Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT04205656
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-16
First Post:
2019-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Evaluation of PRP and BMC Treatment to Accelerate Healing After ACL Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcomes assessor'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-12', 'studyFirstSubmitDate': '2019-12-04', 'studyFirstSubmitQcDate': '2019-12-17', 'lastUpdatePostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': '18 months', 'description': 'Occurrence of adverse events'}], 'secondaryOutcomes': [{'measure': 'Patient reported outcome questionnaire', 'timeFrame': 'screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery', 'description': 'SF-12 Short Form General Health Survey Patient Satisfaction'}, {'measure': 'Measure signature cellular profile of BMC', 'timeFrame': 'Day of Surgery', 'description': 'Flow cytometer to analyze BMC cell concentrations'}, {'measure': 'Measure plasma levels of pro-inflammatory factors in BMC', 'timeFrame': 'Day of Surgery', 'description': 'Multiplex analysis of pro-inflammatory cytokines and chemokines using Luminex 200®'}, {'measure': 'Measure plasma levels of pro-inflammatory factors in LP-PRP', 'timeFrame': 'Day of Surgery', 'description': 'Multiplex analysis of pro-inflammatory cytokines and chemokines using Luminex 200®'}, {'measure': 'Quantitative Magnetic Resonance Imaging (MRI)', 'timeFrame': 'screening, baseline; 6 and 12 months post-surgery', 'description': 'Images acquired on a 3T Siemens Magnetom Skyra-fit scanner'}, {'measure': 'DSX: three dimensional (3D) to measure motion of the knee using dynamix x-ray software', 'timeFrame': '6 and 12 months post-surgery', 'description': 'Up to three brief X-ray exposures (6 scouts x 3 frames and 2 statics x 5 frames and 24 exposures x 100 frames will be acquired)'}, {'measure': 'Computerized tomography (CT): 3D geometry of bony anatomy using a series of x-rays', 'timeFrame': '6 months post-surgery', 'description': 'single, bilateral knee CT scan using Toshiba Aquilon Premium 160 CT scanner'}, {'measure': 'Patient Reported Outcome questionnaire', 'timeFrame': 'screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery', 'description': 'IKDC - International Knee Documentation Committee Score'}, {'measure': 'Patient Reported Outcome questionnaire', 'timeFrame': 'screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery', 'description': 'WOMAC - Western Ontario \\& McMaster Universities Osteoarthritis Index'}, {'measure': 'Patient Reported Outcome questionnaire', 'timeFrame': 'screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery', 'description': 'Lysholm Score'}, {'measure': 'Patient Reported Outcome questionnaire', 'timeFrame': 'screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery', 'description': 'Tegner Activity Scale'}, {'measure': 'Patient Reported Outcome questionnaire', 'timeFrame': 'screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery', 'description': 'NRS (NUMERICAL RATING SCALE) for Pain'}, {'measure': 'Motion Assessment', 'timeFrame': 'screening, baseline; 6 months post-surgery', 'description': '3D video motion capture'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bone marrow concentrate (BMC)', 'stem cell', 'platelet-rich plasma (PRP)', 'anterior cruciate ligament reconstruction (ACLR)'], 'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomized, placebo-controlled trial to evaluate potential beneficial effects of leukocyte-poor platelet rich plasma and bone marrow concentrate on the healing and health of critical joint tissues in the knee following anterior cruciate ligament (ACL) reconstruction. Bone marrow contains stem cells which can change into cells of various different tissue types, while platelet rich plasma contains growth factors. This trial will compare the two procedures against placebo.', 'detailedDescription': "This is a prospective, randomized, placebo-controlled trial. Patients will be randomized into three groups: Concentrated Bone Marrow Concentrate (BMC), Platelet-Rich Plasma (PRP) or Placebo. BMC subjects will have bone marrow aspirated from the subjects iliac crests and the cellular rich portion will be concentrated and subsequently injected into the subjects' symptomatic knee during ACL reconstruction surgery. PRP subjects will have a venous blood draw and the resulting PRP will be injected into the symptomatic knee during ACL reconstruction surgery. Follow-up visits in person will take place at 2 weeks, 6 months and 12 months after the ACL reconstruction surgery.\n\nThe purpose of this study is to evaluate potential beneficial effects of leukocyte-poor platelet-rich plasma (LP-PRP) and bone marrow concentrate (BMC) on the healing and health of all critical joint tissues (grafts/ligaments, meniscus and cartilage) in the knee following anterior cruciate ligament reconstruction (ACLR). Key aspects of this proposal include our well-developed methodologies to quantify and correlate cytokines, chemokines, growth factors in PRP and progenitor cells in BMC, clinical outcomes and imaging following ACLR. The overarching goal of this randomized control trial is to establish a biological signature of PRP and BMC that will be indicative for optimal recovery after ACLR. The long-term goal of our research is to better understand the efficacy of orthobiologic approaches to improve clinical outcomes, enhance graft healing and mitigate post-traumatic osteoarthritis (PTOA) in a cohort of patients that have undergone ACLR."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria: Subjects will be included if all the following criteria are met:\n\n1. Age 16-50 years at the time of Anterior Cruciate Ligament Reconstruction (ACLR) surgery;\n2. Acute ACL injury within 6 months of scheduled ACLR surgery;\n3. Scheduled for unilateral, primary ACLR with a BTB (bone-patellar tendon-bone) autograft;\n4. The following concomitant injuries are allowed:\n\n 1. Meniscal injuries of all types, grades and regardless of surgical treatment;\n 2. Articular chondral injury that can be addressed with debridement or chondroplasty;\n 3. Tibial impaction fractures;\n 4. Non-operative sprains/injuries of MCL or LCL;\n5. Willing and able to comply with all required post-operative visits, biomotion and imaging tests, the self-completion of questionnaires and other trial procedures.\n\nExclusion Criteria: Subjects will be excluded if any of the following criteria are met:\n\n1. Inability to provide informed consent;\n2. Women who are pregnant;\n3. Previous surgery for either knee except in cases of prior diagnostic arthroscopy and/or minimal debridement;\n4. Significant osteoarthritis (OA) of the knee (e.g. grade 4 with cystic changes and/or significant osteophytes);\n5. Concomitant cartilage restoration procedure in the operative knee;\n6. Biologic treatment (e.g. PRP, BMC, prolotherapy, etc.) in the operative knee within 6 months of ACLR surgery;\n7. Steroid injections in the operative knee within 3 months of ACLR surgery;\n8. Open growth plates (determined by the treating physician based on standard-of-care preoperative knee radiographs);\n9. History of deep vein thrombosis (DVT) or pulmonary embolism (PE) that requires additional anticoagulation beyond usual post-operative standard of care;\n10. Current or known history of significant active autoimmune disease (i.e. rheumatoid arthritis and SLE);\n11. Incompatible MRI hardware/devices and/or inability to safely undergo MRI per the MRI safety screening questionnaire;\n12. Known balance or vestibular disorders, if in the opinion of the Principal Investigator or delegated clinician may affect ability to safely comply with study procedures;\n13. History of significant radiation exposure, e.g. due to radiation therapy or occupational exposure;\n14. Active malignancy of any type or history of a malignancy within 2 years of informed consent (with the exception of subjects with a history of treated basal or squamous cell carcinoma);\n15. Concurrent or previous participation in another clinical trial within 30 days prior to informed consent;\n\n 1. Concurrent enrollment in DOD Project 4, Vail Health Hospital IRB # 2018-20, is allowed while subjects on this study are in the 18-month follow-up period;\n 2. Concurrent enrollment in non-interventional registry studies or blood-banking/biomarker studies is allowed;\n16. History of substance abuse (drug or alcohol) that may interfere with the subject's ability to cooperate and comply with the trial procedures;\n17. Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Principal Investigator or delegated clinician, would make the subject inappropriate for entry into this trial.\n\n Subjects will be withdrawn from the study (Screen Failures) after providing informed consent and/or at the time of ACLR surgery if they meet any of the following criteria:\n18. Concurrent reconstruction of any knee ligaments other than the ACL;\n19. ACLR which requires the following concomitant treatments: bone plating, metal implants (with the exception of titanium interference screws) or microfracture;\n20. Inability to collect sufficient research samples (e.g. less than the minimum required amount of BMA is harvested, or clotting occurs)."}, 'identificationModule': {'nctId': 'NCT04205656', 'briefTitle': 'Prospective Evaluation of PRP and BMC Treatment to Accelerate Healing After ACL Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Steadman Philippon Research Institute'}, 'officialTitle': 'Prospective Evaluation of Platelet-Rich Plasma and Bone Marrow Concentrate Treatment to Accelerate Healing After Anterior Cruciate Ligament Reconstruction', 'orgStudyIdInfo': {'id': '2019-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Leukocyte-Poor Platelet Rich Plasma (LP-PRP)', 'description': 'Participants will have a knee injected with Platelet-Rich Plasma (PRP) obtained from a venous whole blood draw from the vein.', 'interventionNames': ['Biological: Leukocyte-Poor Platelet Rich Plasma (LP-PRP)']}, {'type': 'EXPERIMENTAL', 'label': 'Bone Marrow Concentrate (BMC)', 'description': 'Participants will have a knee injected with BMC stem cells harvested from the iliac crest', 'interventionNames': ['Biological: Bone Marrow Concentrate (BMC)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Patients randomized in the placebo arm will undergo their standard of care treatment and will not receive LP-PRP or BMC.', 'interventionNames': ['Other: Control group (Placebo)']}], 'interventions': [{'name': 'Leukocyte-Poor Platelet Rich Plasma (LP-PRP)', 'type': 'BIOLOGICAL', 'description': 'Participants will have a knee injected with Platelet-Rich Plasma (PRP) obtained from a venous whole blood draw from the vein.', 'armGroupLabels': ['Leukocyte-Poor Platelet Rich Plasma (LP-PRP)']}, {'name': 'Bone Marrow Concentrate (BMC)', 'type': 'BIOLOGICAL', 'description': 'Participants will have a knee injected with BMC stem cells harvested from the iliac crest', 'armGroupLabels': ['Bone Marrow Concentrate (BMC)']}, {'name': 'Control group (Placebo)', 'type': 'OTHER', 'description': 'Participants will undergo ACLR surgery with no injection into their knee.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81657-5242', 'city': 'Vail', 'state': 'Colorado', 'country': 'United States', 'facility': '181 West Meadow Drive, Suite 1000', 'geoPoint': {'lat': 39.64026, 'lon': -106.3742}}], 'overallOfficials': [{'name': 'Peter Millett, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Steadman Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Steadman Philippon Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}, {'name': 'Office of Naval Research (ONR)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}