Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT02481869
Status:
COMPLETED
Last Update Posted:
2021-02-05
First Post:
2015-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Platelet Rich Plasma Injection in Pilon Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069237', 'term': 'Arthrocentesis'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D019152', 'term': 'Paracentesis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cookjl@health.missouri.edu', 'phone': '5738827615', 'title': 'Dr. James Cook', 'organization': 'University of Missouri'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '18 months', 'description': 'AEs and SAEs were assessed via a non-systemic approach. Methods of assessment were self-reporting by participants and collection of information from existing medial records for those subjects who did not regularly return for their follow-up visits.', 'eventGroups': [{'id': 'EG000', 'title': 'Platelet Rich Plasma', 'description': 'At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the PRP will be delivered into the same arthrocentesis needle.\n\nNext the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of PRP. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.\n\nAnother aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of PRP, just an aspiration of both injured and uninjured ankles.\n\nArthrocentesis/PRP: PRP (n=20): single intra-articular injection of 5 ml of a leukocyte-reduced platelet rich plasma (ACP, Arthrex, Naples, FL) at the time of closed reduction and initial stabilization using ankle-s', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 1, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Saline', 'description': 'At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the Saline will be delivered into the same arthrocentesis needle.\n\nNext the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of Saline. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.\n\nAnother aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of Saline, just an aspiration of both injured and uninjured ankles.\n\nArthrocentesis/Saline: Control (n=20): single intra-articular injection of 5 ml of sterile 0.9% saline at the time of closed reduction and initial stabilization using ankle-spanning external fixation', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Post-traumatic Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hardware Loosening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Painful Implants', 'notes': 'Painful Implants requiring removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Platelet Rich Plasma', 'description': 'At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected. Using the same needle, the PRP will be delivered. Next the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of PRP. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.\n\nAnother aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of PRP, just an aspiration of both injured and uninjured ankles. Arthrocentesis/PRP: PRP (n=20): single intra-articular injection of 5 ml of a leukocyte-reduced platelet rich plasma (ACP, Arthrex, Naples, FL) at the time of closed reduction and initial stabilization using ankle-spanning external fixation'}, {'id': 'OG001', 'title': 'Saline', 'description': 'At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the Saline will be delivered into the same arthrocentesis needle.\n\nNext the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of Saline. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.\n\nAnother aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of Saline, just an aspiration of both injured and uninjured ankles.\n\nArthrocentesis/Saline: Control (n=20): single intra-articular injection of 5 ml of sterile 0.9% saline at the time of closed reduction and initial stabilization using ankle-spanning external fixation'}], 'classes': [{'title': 'Fractaline', 'categories': [{'measurements': [{'value': '54.89', 'spread': '44.84', 'groupId': 'OG000'}, {'value': '163.01', 'spread': '163.70', 'groupId': 'OG001'}]}]}, {'title': 'GRO-A', 'categories': [{'measurements': [{'value': '2479.17', 'spread': '1560.321', 'groupId': 'OG000'}, {'value': '2511.32', 'spread': '3171.135', 'groupId': 'OG001'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '37.87', 'spread': '31.249', 'groupId': 'OG000'}, {'value': '71.38', 'spread': '58.70', 'groupId': 'OG001'}]}]}, {'title': 'MCP-3', 'categories': [{'measurements': [{'value': '109.59', 'spread': '81.920', 'groupId': 'OG000'}, {'value': '113.59', 'spread': '121.850', 'groupId': 'OG001'}]}]}, {'title': 'PDGF-AA', 'categories': [{'measurements': [{'value': '763.67', 'spread': '770.151', 'groupId': 'OG000'}, {'value': '284.72', 'spread': '245.856', 'groupId': 'OG001'}]}]}, {'title': 'IL-13', 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.656', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '0.341', 'groupId': 'OG001'}]}]}, {'title': 'PDGF-ABBB', 'categories': [{'measurements': [{'value': '3273.77', 'spread': '2439.361', 'groupId': 'OG000'}, {'value': '2246.71', 'spread': '3416.702', 'groupId': 'OG001'}]}]}, {'title': 'IL-1RA', 'categories': [{'measurements': [{'value': '1759.51', 'spread': '1547.219', 'groupId': 'OG000'}, {'value': '2690.89', 'spread': '2015.254', 'groupId': 'OG001'}]}]}, {'title': 'IL-1B', 'categories': [{'measurements': [{'value': '1.62', 'spread': '1.079', 'groupId': 'OG000'}, {'value': '5.95', 'spread': '8.439', 'groupId': 'OG001'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.378', 'groupId': 'OG000'}, {'value': '1.82', 'spread': '1.756', 'groupId': 'OG001'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '9.08', 'spread': '20.303', 'groupId': 'OG001'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '2161.64', 'spread': '2590.332', 'groupId': 'OG000'}, {'value': '2206.67', 'spread': '2584.125', 'groupId': 'OG001'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '2373.21', 'spread': '3787.668', 'groupId': 'OG000'}, {'value': '2554.12', 'spread': '4199.522', 'groupId': 'OG001'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '4290373', 'spread': '3708.968', 'groupId': 'OG000'}, {'value': '4152.51', 'spread': '3541.933', 'groupId': 'OG001'}]}]}, {'title': 'MIP-1A', 'categories': [{'measurements': [{'value': '9.70', 'spread': '17.591', 'groupId': 'OG000'}, {'value': '7.44', 'spread': '5.412', 'groupId': 'OG001'}]}]}, {'title': 'MIP-1B', 'categories': [{'measurements': [{'value': '28.26', 'spread': '46.006', 'groupId': 'OG000'}, {'value': '23.11', 'spread': '10.392', 'groupId': 'OG001'}]}]}, {'title': 'TNF-A', 'categories': [{'measurements': [{'value': '6.21', 'spread': '2.408', 'groupId': 'OG000'}, {'value': '6.46', 'spread': '3.316', 'groupId': 'OG001'}]}]}, {'title': 'VEGF', 'categories': [{'measurements': [{'value': '716.06', 'spread': '838.759', 'groupId': 'OG000'}, {'value': '953.47', 'spread': '1077.999', 'groupId': 'OG001'}]}]}, {'title': 'MMP-2', 'categories': [{'measurements': [{'value': '49985.40', 'spread': '24550.313', 'groupId': 'OG000'}, {'value': '61667.25', 'spread': '6011.542', 'groupId': 'OG001'}]}]}, {'title': 'MMP-1', 'categories': [{'measurements': [{'value': '8482.56', 'spread': '6398.284', 'groupId': 'OG000'}, {'value': '10643.50', 'spread': '5011.581', 'groupId': 'OG001'}]}]}, {'title': 'MMP-7', 'categories': [{'measurements': [{'value': '21182.40', 'spread': '19303.296', 'groupId': 'OG000'}, {'value': '43418.25', 'spread': '37425.332', 'groupId': 'OG001'}]}]}, {'title': 'MMP-9', 'categories': [{'measurements': [{'value': '23974.72', 'spread': '36530.879', 'groupId': 'OG000'}, {'value': '7628.05', 'spread': '11921.451', 'groupId': 'OG001'}]}]}, {'title': 'Prostaglandin E2 (PGE2)', 'categories': [{'measurements': [{'value': '709.43', 'spread': '1165.492', 'groupId': 'OG000'}, {'value': '411.76', 'spread': '646.284', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks after external fixation', 'description': 'Inflammatory Biomarkers will be measured (pg/ml) at the time of definitive Fixation', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Presence of Post-traumatic Osteoarthritis 18 Months After Open Reduction Internal Fixation (ORIF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Platelet Rich Plasma', 'description': 'At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the PRP will be delivered into the same arthrocentesis needle.\n\nNext the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of PRP. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.\n\nAnother aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of PRP, just an aspiration of both injured and uninjured ankles.\n\nArthrocentesis/PRP: PRP (n=20): single intra-articular injection of 5 ml of a leukocyte-reduced platelet rich plasma (ACP, Arthrex, Naples, FL) at the time of closed reduction and initial stabilization using ankle-s'}, {'id': 'OG001', 'title': 'Saline', 'description': 'At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the Saline will be delivered into the same arthrocentesis needle.\n\nNext the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of Saline. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.\n\nAnother aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of Saline, just an aspiration of both injured and uninjured ankles.\n\nArthrocentesis/Saline: Control (n=20): single intra-articular injection of 5 ml of sterile 0.9% saline at the time of closed reduction and initial stabilization using ankle-spanning external fixation'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '18 months after ORIF', 'description': 'Post-traumatic Osteoarthritis will be determined from whole-joint Magnetic Resonance Imaging (MRI)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 2 subjects in the Saline group completed the MRI at 18 months after surgery. None of the subjects in the Platelet Rich Plasma (PRP) group completed the MRI'}, {'type': 'SECONDARY', 'title': 'Patient Reported Outcomes (PROs): Ankle-Hindfoot Scale (AOFAS), Short Form Health Survey (SF-12), and Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Platelet Rich Plasma', 'description': 'At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the PRP will be delivered into the same arthrocentesis needle.\n\nNext the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of PRP. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.\n\nAnother aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of PRP, just an aspiration of both injured and uninjured ankles.\n\nArthrocentesis/PRP: PRP (n=20): single intra-articular injection of 5 ml of a leukocyte-reduced platelet rich plasma (ACP, Arthrex, Naples, FL) at the time of closed reduction and initial stabilization using ankle-s'}, {'id': 'OG001', 'title': 'Saline', 'description': 'At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the Saline will be delivered into the same arthrocentesis needle.\n\nNext the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of Saline. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.\n\nAnother aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of Saline, just an aspiration of both injured and uninjured ankles.\n\nArthrocentesis/Saline: Control (n=20): single intra-articular injection of 5 ml of sterile 0.9% saline at the time of closed reduction and initial stabilization using ankle-spanning external fixation'}], 'classes': [{'title': 'SF-12 Physical Score', 'categories': [{'measurements': [{'value': '24.11', 'spread': '1.95', 'groupId': 'OG000'}, {'value': '28.96', 'spread': '4.62', 'groupId': 'OG001'}]}]}, {'title': 'SF-12 Mental Score', 'categories': [{'measurements': [{'value': '58.06', 'spread': '12.24', 'groupId': 'OG000'}, {'value': '48.97', 'spread': '10.47', 'groupId': 'OG001'}]}]}, {'title': 'AOFAS Pain Score', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '6.60', 'spread': '7.092', 'groupId': 'OG001'}]}]}, {'title': 'AOFAS Total Score', 'categories': [{'measurements': [{'value': '15.00', 'spread': '21.213', 'groupId': 'OG000'}, {'value': '15.00', 'spread': '10.000', 'groupId': 'OG001'}]}]}, {'title': 'AOFAS Function Score', 'categories': [{'measurements': [{'value': '15.00', 'spread': '21.213', 'groupId': 'OG000'}, {'value': '19.50', 'spread': '4.933', 'groupId': 'OG001'}]}]}, {'title': 'VAS Score', 'categories': [{'measurements': [{'value': '5.12', 'spread': '4.66', 'groupId': 'OG000'}, {'value': '5.86', 'spread': '2.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks after ORIF', 'description': "The AOFAS is a standardized evaluation of the clinical status of the ankle-hindfoot. In uses both subjective \\& objective information. Patients report their pain (40 possible points), physicians assess alignment (10 possible points) \\& the patient and physician work together to complete the function portion (50 possible points). Total scores range from 0-100, with healthy ankles receiving 100.\n\nThe SF-12 assesses the impact of health on an individual's everyday life. The 2 scores are reported from the SF12 - a mental componet score (MCS) and a physical component score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations (SD). The US average PCS-12 and MCS are both 50 points. The US population SD is 10 points. So each 10 increment of 10 point or above or below 50, corresponds to 1 SD away from the average.\n\nVAS measures the amount of pain a patient feels on a continuum from 0=no pain to 100=worst pain.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Reported Outcomes (PROs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Platelet Rich Plasma', 'description': 'At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the PRP will be delivered into the same arthrocentesis needle.\n\nNext the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of PRP. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.\n\nAnother aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of PRP, just an aspiration of both injured and uninjured ankles.\n\nArthrocentesis/PRP: PRP (n=20): single intra-articular injection of 5 ml of a leukocyte-reduced platelet rich plasma (ACP, Arthrex, Naples, FL) at the time of closed reduction and initial stabilization using ankle-s'}, {'id': 'OG001', 'title': 'Saline', 'description': 'At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the Saline will be delivered into the same arthrocentesis needle.\n\nNext the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of Saline. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.\n\nAnother aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of Saline, just an aspiration of both injured and uninjured ankles.\n\nArthrocentesis/Saline: Control (n=20): single intra-articular injection of 5 ml of sterile 0.9% saline at the time of closed reduction and initial stabilization using ankle-spanning external fixation'}], 'classes': [{'title': 'SF-12 Physical Score', 'categories': [{'measurements': [{'value': '27.47', 'spread': '11.34', 'groupId': 'OG000'}, {'value': '34.39', 'spread': '2.60', 'groupId': 'OG001'}]}]}, {'title': 'SF-12 Mental Score', 'categories': [{'measurements': [{'value': '49.09', 'spread': '13.16', 'groupId': 'OG000'}, {'value': '41.48', 'spread': '5.79', 'groupId': 'OG001'}]}]}, {'title': 'AOFAS Pain Score', 'categories': [{'measurements': [{'value': '15.00', 'spread': '21.213', 'groupId': 'OG000'}, {'value': '25.00', 'spread': '5.774', 'groupId': 'OG001'}]}]}, {'title': 'AOFAS Total Score', 'categories': [{'measurements': [{'value': '15.00', 'spread': '28.75', 'groupId': 'OG000'}, {'value': '21.213', 'spread': '8.808', 'groupId': 'OG001'}]}]}, {'title': 'AOFAS Function Score', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '3.75', 'spread': '3.775', 'groupId': 'OG001'}]}]}, {'title': 'VAS Score', 'categories': [{'measurements': [{'value': '5.50', 'spread': '6.36', 'groupId': 'OG000'}, {'value': '3.33', 'spread': '1.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after ORIF', 'description': "The AOFAS is a standardized evaluation of the clinical status of the ankle-hindfoot. In uses both subjective \\& objective information. Patients report their pain (40 possible points), physicians assess alignment (10 possible points) \\& the patient and physician work together to complete the function portion (50 possible points). Total scores range from 0-100, with healthy ankles receiving 100.\n\nThe SF-12 assesses the impact of health on an individual's everyday life. The 2 scores are reported from the SF12 - a mental componet score (MCS) and a physical component score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations (SD). The US average PCS-12 and MCS are both 50 points. The US population SD is 10 points. So each 10 increment of 10 point or above or below 50, corresponds to 1 SD away from the average.\n\nVAS measures the amount of pain a patient feels on a continuum from 0=no pain to 100=worst pain.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Reported Outcomes (PROs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Platelet Rich Plasma', 'description': 'At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the PRP will be delivered into the same arthrocentesis needle.\n\nNext the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of PRP. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.\n\nAnother aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of PRP, just an aspiration of both injured and uninjured ankles.\n\nArthrocentesis/PRP: PRP (n=20): single intra-articular injection of 5 ml of a leukocyte-reduced platelet rich plasma (ACP, Arthrex, Naples, FL) at the time of closed reduction and initial stabilization using ankle-s'}, {'id': 'OG001', 'title': 'Saline', 'description': 'At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the Saline will be delivered into the same arthrocentesis needle.\n\nNext the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of Saline. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.\n\nAnother aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of Saline, just an aspiration of both injured and uninjured ankles.\n\nArthrocentesis/Saline: Control (n=20): single intra-articular injection of 5 ml of sterile 0.9% saline at the time of closed reduction and initial stabilization using ankle-spanning external fixation'}], 'classes': [{'title': 'SF-12 Physical Score', 'categories': [{'measurements': [{'value': '37.210', 'groupId': 'OG000'}, {'value': '42.11', 'spread': '8.4', 'groupId': 'OG001'}]}]}, {'title': 'SF-12 Mental Score', 'categories': [{'measurements': [{'value': '60.1', 'groupId': 'OG000'}, {'value': '48.67', 'spread': '13.24', 'groupId': 'OG001'}]}]}, {'title': 'AOFAS Pain Score', 'categories': [{'measurements': [{'value': '40.00', 'groupId': 'OG000'}, {'value': '30.00', 'spread': '8.16', 'groupId': 'OG001'}]}]}, {'title': 'AOFAS Total Score', 'categories': [{'measurements': [{'value': '45.00', 'groupId': 'OG000'}, {'value': '39.25', 'spread': '11.383', 'groupId': 'OG001'}]}]}, {'title': 'AOFAS Function Score', 'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000'}, {'value': '9.25', 'spread': '7.042', 'groupId': 'OG001'}]}]}, {'title': 'VAS Score', 'categories': [{'measurements': [{'value': '1.000', 'groupId': 'OG000'}, {'value': '1.7625', 'spread': '1.017', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks after ORIF', 'description': "The AOFAS is a standardized evaluation of the clinical status of the ankle-hindfoot. In uses both subjective \\& objective information. Patients report their pain (40 possible points), physicians assess alignment (10 possible points) \\& the patient and physician work together to complete the function portion (50 possible points). Total scores range from 0-100, with healthy ankles receiving 100.\n\nThe SF-12 assesses the impact of health on an individual's everyday life. The 2 scores are reported from the SF12 - a mental componet score (MCS) and a physical component score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations (SD). The US average PCS-12 and MCS are both 50 points. The US population SD is 10 points. So each 10 increment of 10 point or above or below 50, corresponds to 1 SD away from the average.\n\nVAS measures the amount of pain a patient feels on a continuum from 0=no pain to 100=worst pain.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Reported Outcomes (PROs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Platelet Rich Plasma', 'description': 'At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the PRP will be delivered into the same arthrocentesis needle.\n\nNext the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of PRP. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.\n\nAnother aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of PRP, just an aspiration of both injured and uninjured ankles.\n\nArthrocentesis/PRP: PRP (n=20): single intra-articular injection of 5 ml of a leukocyte-reduced platelet rich plasma (ACP, Arthrex, Naples, FL) at the time of closed reduction and initial stabilization using ankle-s'}, {'id': 'OG001', 'title': 'Saline', 'description': 'At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the Saline will be delivered into the same arthrocentesis needle.\n\nNext the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of Saline. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.\n\nAnother aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of Saline, just an aspiration of both injured and uninjured ankles.\n\nArthrocentesis/Saline: Control (n=20): single intra-articular injection of 5 ml of sterile 0.9% saline at the time of closed reduction and initial stabilization using ankle-spanning external fixation'}], 'classes': [{'title': 'SF-12 Physical Score', 'categories': [{'measurements': [{'value': '50.62', 'groupId': 'OG000'}, {'value': '46.54', 'spread': '8.91', 'groupId': 'OG001'}]}]}, {'title': 'SF-12 Mental Score', 'categories': [{'measurements': [{'value': '61.18', 'groupId': 'OG000'}, {'value': '39.29', 'spread': '7.27', 'groupId': 'OG001'}]}]}, {'title': 'AOFAS Pain Score', 'categories': [{'measurements': [{'value': '30.00', 'groupId': 'OG000'}, {'value': '25.00', 'spread': '7.071', 'groupId': 'OG001'}]}]}, {'title': 'AOFAS Total Score', 'categories': [{'measurements': [{'value': '45.00', 'groupId': 'OG000'}, {'value': '39.50', 'spread': '10.607', 'groupId': 'OG001'}]}]}, {'title': 'AOFAS Function Score', 'categories': [{'measurements': [{'value': '15.00', 'groupId': 'OG000'}, {'value': '14.50', 'spread': '3.536', 'groupId': 'OG001'}]}]}, {'title': 'VAS Score', 'categories': [{'measurements': [{'value': '1.000', 'groupId': 'OG000'}, {'value': '3.87', 'spread': '2.50', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months after ORIF', 'description': "The AOFAS is a standardized evaluation of the clinical status of the ankle-hindfoot. In uses both subjective \\& objective information. Patients report their pain (40 possible points), physicians assess alignment (10 possible points) \\& the patient and physician work together to complete the function portion (50 possible points). Total scores range from 0-100, with healthy ankles receiving 100.\n\nThe SF-12 assesses the impact of health on an individual's everyday life. The 2 scores are reported from the SF12 - a mental componet score (MCS) and a physical component score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations (SD). The US average PCS-12 and MCS are both 50 points. The US population SD is 10 points. So each 10 increment of 10 point or above or below 50, corresponds to 1 SD away from the average.\n\nVAS measures the amount of pain a patient feels on a continuum from 0=no pain to 100=worst pain.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Reported Outcomes (PROs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Platelet Rich Plasma', 'description': 'At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the PRP will be delivered into the same arthrocentesis needle.\n\nNext the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of PRP. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.\n\nAnother aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of PRP, just an aspiration of both injured and uninjured ankles.\n\nArthrocentesis/PRP: PRP (n=20): single intra-articular injection of 5 ml of a leukocyte-reduced platelet rich plasma (ACP, Arthrex, Naples, FL) at the time of closed reduction and initial stabilization using ankle-s'}, {'id': 'OG001', 'title': 'Saline', 'description': 'At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the Saline will be delivered into the same arthrocentesis needle.\n\nNext the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of Saline. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.\n\nAnother aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of Saline, just an aspiration of both injured and uninjured ankles.\n\nArthrocentesis/Saline: Control (n=20): single intra-articular injection of 5 ml of sterile 0.9% saline at the time of closed reduction and initial stabilization using ankle-spanning external fixation'}], 'classes': [{'title': 'SF-12 Physical Score', 'categories': [{'measurements': [{'value': '51.14', 'spread': '5.9', 'groupId': 'OG001'}]}]}, {'title': 'SF-12 Mental Score', 'categories': [{'measurements': [{'value': '41.13', 'spread': '24.88', 'groupId': 'OG001'}]}]}, {'title': 'AOFAS Pain Score', 'categories': [{'measurements': [{'value': '30.00', 'spread': '0.000', 'groupId': 'OG001'}]}]}, {'title': 'AOFAS Total Score', 'categories': [{'measurements': [{'value': '46.50', 'spread': '2.121', 'groupId': 'OG001'}]}]}, {'title': 'AOFAS Function Score', 'categories': [{'measurements': [{'value': '16.50', 'spread': '2.121', 'groupId': 'OG001'}]}]}, {'title': 'VAS Score', 'categories': [{'measurements': [{'value': '1.4250', 'spread': '0.60104', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months after ORIF', 'description': "The AOFAS is a standardized evaluation of the clinical status of the ankle-hindfoot. In uses both subjective \\& objective information. Patients report their pain (40 possible points), physicians assess alignment (10 possible points) \\& the patient and physician work together to complete the function portion (50 possible points). Total scores range from 0-100, with healthy ankles receiving 100.\n\nThe SF-12 assesses the impact of health on an individual's everyday life. The 2 scores are reported from the SF12 - a mental componet score (MCS) and a physical component score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations (SD). The US average PCS-12 and MCS are both 50 points. The US population SD is 10 points. So each 10 increment of 10 point or above or below 50, corresponds to 1 SD away from the average.\n\nVAS measures the amount of pain a patient feels on a continuum from 0=no pain to 100=worst pain.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 2 subjects in the saline group completed the PRO for the 12 months follow up time-frame. All the subjects in the PRP group were lost to follow up'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Platelet Rich Plasma', 'description': 'At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the PRP will be delivered into the same arthrocentesis needle.\n\nNext the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of PRP. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.\n\nAnother aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of PRP, just an aspiration of both injured and uninjured ankles.\n\nArthrocentesis/PRP: PRP (n=20): single intra-articular injection of 5 ml of a leukocyte-reduced platelet rich plasma (ACP, Arthrex, Naples, FL) at the time of closed reduction and initial stabilization using ankle-s'}, {'id': 'FG001', 'title': 'Saline', 'description': 'At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the Saline will be delivered into the same arthrocentesis needle.\n\nNext the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of Saline. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.\n\nAnother aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of Saline, just an aspiration of both injured and uninjured ankles.\n\nArthrocentesis/Saline: Control (n=20): single intra-articular injection of 5 ml of sterile 0.9% saline at the time of closed reduction and initial stabilization using ankle-spanning external fixation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Plan for total enrollment of n=40 with n=20 in the PRP arm and n=20 in the saline arm'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Platelet Rich Plasma', 'description': 'At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. A needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected. Using the same needle, the PRP will be delivered into the joint.\n\nNext the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of PRP. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.\n\nAnother aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of PRP, just an aspiration of both injured and uninjured ankles.\n\nArthrocentesis/PRP: PRP (n=20): single intra-articular injection of 5 ml of a leukocyte-reduced platelet rich plasma (ACP, Arthrex, Naples, FL) at the time of closed reduction and initial stabilization using ankle-spanning external fixation'}, {'id': 'BG001', 'title': 'Saline', 'description': 'At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the Saline will be delivered into the same arthrocentesis needle.\n\nNext the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of Saline. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.\n\nAnother aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of Saline, just an aspiration of both injured and uninjured ankles.\n\nArthrocentesis/Saline: Control (n=20): single intra-articular injection of 5 ml of sterile 0.9% saline at the time of closed reduction and initial stabilization using ankle-spanning external fixation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.66', 'spread': '11.77', 'groupId': 'BG000'}, {'value': '48.88', 'spread': '17.97', 'groupId': 'BG001'}, {'value': '44.47', 'spread': '15.43', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-30', 'size': 151750, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-06-04T14:40', 'hasProtocol': True}, {'date': '2016-08-30', 'size': 139622, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-06-04T14:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-13', 'studyFirstSubmitDate': '2015-06-11', 'resultsFirstSubmitDate': '2020-08-11', 'studyFirstSubmitQcDate': '2015-06-24', 'lastUpdatePostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-13', 'studyFirstPostDateStruct': {'date': '2015-06-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation', 'timeFrame': '2 weeks after external fixation', 'description': 'Inflammatory Biomarkers will be measured (pg/ml) at the time of definitive Fixation'}, {'measure': 'Number of Participants With Presence of Post-traumatic Osteoarthritis 18 Months After Open Reduction Internal Fixation (ORIF)', 'timeFrame': '18 months after ORIF', 'description': 'Post-traumatic Osteoarthritis will be determined from whole-joint Magnetic Resonance Imaging (MRI)'}], 'secondaryOutcomes': [{'measure': 'Patient Reported Outcomes (PROs): Ankle-Hindfoot Scale (AOFAS), Short Form Health Survey (SF-12), and Visual Analog Scale (VAS)', 'timeFrame': '2 weeks after ORIF', 'description': "The AOFAS is a standardized evaluation of the clinical status of the ankle-hindfoot. In uses both subjective \\& objective information. Patients report their pain (40 possible points), physicians assess alignment (10 possible points) \\& the patient and physician work together to complete the function portion (50 possible points). Total scores range from 0-100, with healthy ankles receiving 100.\n\nThe SF-12 assesses the impact of health on an individual's everyday life. The 2 scores are reported from the SF12 - a mental componet score (MCS) and a physical component score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations (SD). The US average PCS-12 and MCS are both 50 points. The US population SD is 10 points. So each 10 increment of 10 point or above or below 50, corresponds to 1 SD away from the average.\n\nVAS measures the amount of pain a patient feels on a continuum from 0=no pain to 100=worst pain."}, {'measure': 'Patient Reported Outcomes (PROs)', 'timeFrame': '6 weeks after ORIF', 'description': "The AOFAS is a standardized evaluation of the clinical status of the ankle-hindfoot. In uses both subjective \\& objective information. Patients report their pain (40 possible points), physicians assess alignment (10 possible points) \\& the patient and physician work together to complete the function portion (50 possible points). Total scores range from 0-100, with healthy ankles receiving 100.\n\nThe SF-12 assesses the impact of health on an individual's everyday life. The 2 scores are reported from the SF12 - a mental componet score (MCS) and a physical component score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations (SD). The US average PCS-12 and MCS are both 50 points. The US population SD is 10 points. So each 10 increment of 10 point or above or below 50, corresponds to 1 SD away from the average.\n\nVAS measures the amount of pain a patient feels on a continuum from 0=no pain to 100=worst pain."}, {'measure': 'Patient Reported Outcomes (PROs)', 'timeFrame': '12 weeks after ORIF', 'description': "The AOFAS is a standardized evaluation of the clinical status of the ankle-hindfoot. In uses both subjective \\& objective information. Patients report their pain (40 possible points), physicians assess alignment (10 possible points) \\& the patient and physician work together to complete the function portion (50 possible points). Total scores range from 0-100, with healthy ankles receiving 100.\n\nThe SF-12 assesses the impact of health on an individual's everyday life. The 2 scores are reported from the SF12 - a mental componet score (MCS) and a physical component score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations (SD). The US average PCS-12 and MCS are both 50 points. The US population SD is 10 points. So each 10 increment of 10 point or above or below 50, corresponds to 1 SD away from the average.\n\nVAS measures the amount of pain a patient feels on a continuum from 0=no pain to 100=worst pain."}, {'measure': 'Patient Reported Outcomes (PROs)', 'timeFrame': '6 months after ORIF', 'description': "The AOFAS is a standardized evaluation of the clinical status of the ankle-hindfoot. In uses both subjective \\& objective information. Patients report their pain (40 possible points), physicians assess alignment (10 possible points) \\& the patient and physician work together to complete the function portion (50 possible points). Total scores range from 0-100, with healthy ankles receiving 100.\n\nThe SF-12 assesses the impact of health on an individual's everyday life. The 2 scores are reported from the SF12 - a mental componet score (MCS) and a physical component score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations (SD). The US average PCS-12 and MCS are both 50 points. The US population SD is 10 points. So each 10 increment of 10 point or above or below 50, corresponds to 1 SD away from the average.\n\nVAS measures the amount of pain a patient feels on a continuum from 0=no pain to 100=worst pain."}, {'measure': 'Patient Reported Outcomes (PROs)', 'timeFrame': '12 months after ORIF', 'description': "The AOFAS is a standardized evaluation of the clinical status of the ankle-hindfoot. In uses both subjective \\& objective information. Patients report their pain (40 possible points), physicians assess alignment (10 possible points) \\& the patient and physician work together to complete the function portion (50 possible points). Total scores range from 0-100, with healthy ankles receiving 100.\n\nThe SF-12 assesses the impact of health on an individual's everyday life. The 2 scores are reported from the SF12 - a mental componet score (MCS) and a physical component score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations (SD). The US average PCS-12 and MCS are both 50 points. The US population SD is 10 points. So each 10 increment of 10 point or above or below 50, corresponds to 1 SD away from the average.\n\nVAS measures the amount of pain a patient feels on a continuum from 0=no pain to 100=worst pain."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Closed', 'unilateral', 'pilon'], 'conditions': ['Fracture']}, 'referencesModule': {'references': [{'pmid': '12571307', 'type': 'BACKGROUND', 'citation': 'Marsh JL, Weigel DP, Dirschl DR. Tibial plafond fractures. How do these ankles function over time? J Bone Joint Surg Am. 2003 Feb;85(2):287-95.'}, {'pmid': '16912423', 'type': 'BACKGROUND', 'citation': 'Martin JA, Buckwalter JA. Post-traumatic osteoarthritis: the role of stress induced chondrocyte damage. Biorheology. 2006;43(3,4):517-21.'}, {'pmid': '16649187', 'type': 'BACKGROUND', 'citation': 'Green DM, Noble PC, Ahuero JS, Birdsall HH. Cellular events leading to chondrocyte death after cartilage impact injury. Arthritis Rheum. 2006 May;54(5):1509-17. doi: 10.1002/art.21812.'}, {'pmid': '15232421', 'type': 'BACKGROUND', 'citation': 'Guilak F, Fermor B, Keefe FJ, Kraus VB, Olson SA, Pisetsky DS, Setton LA, Weinberg JB. The role of biomechanics and inflammation in cartilage injury and repair. Clin Orthop Relat Res. 2004 Jun;(423):17-26. doi: 10.1097/01.blo.0000131233.83640.91.'}, {'pmid': '24155495', 'type': 'BACKGROUND', 'citation': 'Franklin SP, Cook JL. Prospective trial of autologous conditioned plasma versus hyaluronan plus corticosteroid for elbow osteoarthritis in dogs. Can Vet J. 2013 Sep;54(9):881-4.'}, {'pmid': '25005436', 'type': 'BACKGROUND', 'citation': 'Waters NP, Stoker AM, Carson WL, Pfeiffer FM, Cook JL. Biomarkers affected by impact velocity and maximum strain of cartilage during injury. J Biomech. 2014 Sep 22;47(12):3185-95. doi: 10.1016/j.jbiomech.2014.06.015. Epub 2014 Jun 21.'}, {'pmid': '24858662', 'type': 'BACKGROUND', 'citation': 'Waters NP, Stoker AM, Pfeiffer FM, Cook JL. Biomarkers Affected by Impact Severity during Osteochondral Injury. J Knee Surg. 2015 Jun;28(3):191-200. doi: 10.1055/s-0034-1376329. Epub 2014 May 23.'}, {'pmid': '22303754', 'type': 'BACKGROUND', 'citation': 'Garner BC, Stoker AM, Kuroki K, Evans R, Cook CR, Cook JL. Using animal models in osteoarthritis biomarker research. J Knee Surg. 2011 Dec;24(4):251-64. doi: 10.1055/s-0031-1297361.'}, {'pmid': '21076249', 'type': 'BACKGROUND', 'citation': 'Thomas TP, Anderson DD, Mosqueda TV, Van Hofwegen CJ, Hillis SL, Marsh JL, Brown TD. Objective CT-based metrics of articular fracture severity to assess risk for posttraumatic osteoarthritis. J Orthop Trauma. 2010 Dec;24(12):764-9. doi: 10.1097/BOT.0b013e3181d7a0aa.'}]}, 'descriptionModule': {'briefSummary': "Patients who sustain broken ankles have a very high risk of developing arthritis soon after injury (within 2 years). This arthritis can cause increased pain and a decrease level of function, especially if the injury occurs at an early age. During and shortly after ankle injury, there is an inflammatory chemical process that takes place in the ankle that can cause damage to the cartilage in the ankle joint. The investigators want to use what is called Platelet Rich Plasma (PRP), which is produced from a small amount of the patient's own blood, to inject into the injured ankle to see if they can decrease the inflammation that happens after the injury and to see if they can decrease arthritis.", 'detailedDescription': "Patients who sustain broken ankles have a very high risk of developing arthritis soon after their injury (within 2 years). This arthritis can cause increased pain and decreased level of function, especially if the injury occurs at an early age. During and shortly after the ankle injury, there is an inflammatory chemical processes that take place in the ankle that can cause damage to the cartilage in the ankle joint. Currently the treatment for this injury is doing surgery is a two step process. When the patient has an ankle fracture, surgeons will stabilize the fracture with an external fixation device to allow ankle swelling to decrease which has been shown improve outcomes within a few hours. After about 10 days the patient will come back for their final surgery in which surgeons will open the ankle joint and make sure that the joint lines up and fix it with plates and screws.\n\nThere is no intervention that is done with regards to the physiologic process that goes on inside the ankle joint when the ankle is injured. This is what the investigators intend to study. There is a very large destructive process that may contribute with the early development to arthritis.\n\nThe investigators would like to see the effect of this inflammatory response with the addition of platelet rich plasma (PRP) which is produced from a small vial of the patient's own blood. PRP has been used safely in patients with osteoarthritis and has been shown to slow the progression and improve pain scores. PRP is made by spinning the patient's blood in a centrifuge which separates the blood cells from each other. The bloods cells that are anti-inflammatory in nature are taken and placed in another syringe. This is a blinded randomized control study. There will be two groups in which the patients will randomize into: PRP group, or Normal Saline Group. In both groups, the investigator's plan is to withdraw joint fluid from both the injured and uninjured ankle at the time of the first surgery as to analyze the joint fluid from both ankles.\n\nParticipants who are randomized into the PRP group will receive PRP in the injured ankle at the time of the first surgery when the external fixator is placed. Participants who are randomized into the Normal Saline group will receive Normal Saline in the injured ankle at the time of the first surgery when the external fixator is placed.\n\nAfter 7-14 days the participant will return and have their second surgery for definitive fixation. At the time of surgery, joint fluid will again be taken out of the joint for analysis to see if the PRP decreased the anti-inflammatory cells decreased inflammation. After the second surgery the participant will be followed up in the clinic in a regular manner."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Closed unilateral pilon fracture\n\nExclusion Criteria:\n\n* Patients who are younger than 18 years of age\n* Open pilon fracture\n* Patients with contralateral lower extremity injury\n* Patients unable to comply with the follow-up appointments\n* Patients who had previous ankle injury to the currently injured ankle\n* Patients who are pregnant\n* Prisoners'}, 'identificationModule': {'nctId': 'NCT02481869', 'briefTitle': 'Platelet Rich Plasma Injection in Pilon Fractures', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Does Early Platelet Rich Plasma Injection Decrease the Risk of Post-traumatic Arthritis in Pilon Fractures Undergoing Two-staged Open Reduction With Internal Fixation?', 'orgStudyIdInfo': {'id': '2002117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arthrocentesis/PRP', 'description': 'At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the PRP will be delivered into the same arthrocentesis needle.\n\nNext the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of PRP. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.\n\nAnother aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of PRP, just an aspiration of both injured and uninjured ankles.', 'interventionNames': ['Biological: Arthrocentesis/PRP']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arthrocentesis/Saline', 'description': 'At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the Saline will be delivered into the same arthrocentesis needle.\n\nNext the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of Saline. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.\n\nAnother aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of Saline, just an aspiration of both injured and uninjured ankles.', 'interventionNames': ['Drug: Arthrocentesis/Saline']}], 'interventions': [{'name': 'Arthrocentesis/PRP', 'type': 'BIOLOGICAL', 'otherNames': ['platelet-rich plasma'], 'description': 'PRP (n=20): single intra-articular injection of 5 ml of a leukocyte-reduced platelet rich plasma (ACP, Arthrex, Naples, FL) at the time of closed reduction and initial stabilization using ankle-spanning external fixation', 'armGroupLabels': ['Arthrocentesis/PRP']}, {'name': 'Arthrocentesis/Saline', 'type': 'DRUG', 'otherNames': ['saline'], 'description': 'Control (n=20): single intra-articular injection of 5 ml of sterile 0.9% saline at the time of closed reduction and initial stabilization using ankle-spanning external fixation', 'armGroupLabels': ['Arthrocentesis/Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'overallOfficials': [{'name': 'Brett D Crist, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Missouri-Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Co-Director of Trauma Services, Co-Director Orthopaedic Trauma Fellowship, Department of Orthopaedic Surgery', 'investigatorFullName': 'Brett Crist', 'investigatorAffiliation': 'University of Missouri-Columbia'}}}}