Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-04-18 @ 3:57 AM
Study NCT ID:
NCT02811003
Status:
COMPLETED
Last Update Posted:
2022-11-04
First Post:
2016-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Achilles Tendon Repair With Bioinductive Implant
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052256', 'term': 'Tendinopathy'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'samantha.andrews@smith-nephew.com', 'phone': '978.971.8990', 'title': 'Samantha Andrews', 'organization': 'Smith+Nephew, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the time of surgery through 24 month follow-up.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment', 'description': 'Treatment with Rotation Medical Bioinductive Implant\n\nRotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 4, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Numbness', 'notes': 'Not related to study device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inversion Injury', 'notes': 'Not related to study device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetes', 'notes': 'Not related to study device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pacemaker Implanted', 'notes': 'Not related to study device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Muscle, tendon and ligament injury', 'notes': 'Not related to study device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'New Tissue Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Treatment with Rotation Medical Bioinductive Implant\n\nRotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy'}], 'classes': [{'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.40', 'spread': '1.08', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.70', 'spread': '0.78', 'groupId': 'OG000'}]}]}, {'title': '24 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.50', 'spread': '0.92', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3, 12, and 24 months', 'description': 'Measurement of new tissue thickness in millimeters will be made from sagittal magnetic resonance imaging (MRI) at the level of the bone anchor. These measurements were made distal to the attachment of the Achilles tendon, which do not include the thickness of the repaired tendon; therefore, these thicknesses represent the thickness of the newly induced tissue only.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The 3-month MRI for 1 participant did not include the necessary images for thickness measurement; thus, there were only 18 measurements at 3 months. The 12-month MRIs for 3 participants did not include the necessary images for thickness measurement, therefore, there were only 13 measurements at 12 months. The 24-month MRIs for 1 participant did not include the necessary images for thickness measurement, therefore, there were only 15 measurements at 24 months.'}, {'type': 'PRIMARY', 'title': 'MRI Measurements of Tendon Thickening (Combined Tendon and New Tissue)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Treatment with Rotation Medical Bioinductive Implant\n\nRotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy'}], 'classes': [{'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.20', 'spread': '2.47', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.80', 'spread': '4.58', 'groupId': 'OG000'}]}]}, {'title': '24 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.40', 'spread': '2.84', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3, 12, and 24 months', 'description': 'Combined measurement of tendon and new tissue thickness in millimeters will be made from sagittal magnetic resonance imaging (MRI) at the insertion (approximately 5-10mm proximal to the bone anchor).', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The 3-month MRI for 1 participant did not include the necessary images for thickness measurement; thus, there were only 18 measurements at 3 months. The 12-month MRIs for 3 participants did not include the necessary images for thickness measurement, therefore, there were only 13 measurements at 12 months. The 24-month MRIs for 1 participant did not include the necessary images for thickness measurement, therefore, there were only 15 measurements at 24 months.'}, {'type': 'PRIMARY', 'title': 'Tear Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Treatment with Rotation Medical Bioinductive Implant\n\nRotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy'}], 'classes': [{'categories': [{'title': 'No Tear', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Tear', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'following surgery to end of treatment at 24 months', 'description': 'Tear rate in the deep portion of the repair at the calcaneus following Achilles surgery will be assessed at each follow-up visit using magnetic resonance imaging (MRI).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Device Implant Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Treatment with Rotation Medical Bioinductive Implant\n\nRotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy'}], 'classes': [{'categories': [{'measurements': [{'value': '5.40', 'spread': '1.57', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Intraoperatively, up to 9 minutes', 'description': 'Time in minutes from introduction of the bioinductive implant into the surgical field to completion of the last staple', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Procedure Technical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Treatment with Rotation Medical Bioinductive Implant\n\nRotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy'}], 'classes': [{'categories': [{'title': 'Device Successfully Implanted', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': 'Device Not Successfully Implanted', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraoperatively, up to 9 minutes', 'description': 'The number of participants where the device was successfully delivered and affixed to target tendon location (i.e., study device was successfully implanted).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CAM Boot Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Treatment with Rotation Medical Bioinductive Implant\n\nRotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy'}], 'classes': [{'categories': [{'measurements': [{'value': '76.30', 'spread': '29.32', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week following surgery to 12 months', 'description': 'Cumulative number of days spent in a controlled ankle motion walking boot (CAM boot).', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The calculated mean time wearing the boot was based on only 16 patients because 3 patients who wore the boot more than 90 days did not report the actual date they stopped wearing the boot; therefore, the actual time wearing the boot was greater than the calculated mean.'}, {'type': 'SECONDARY', 'title': 'Rehabilitation Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Treatment with Rotation Medical Bioinductive Implant\n\nRotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy'}], 'classes': [{'categories': [{'measurements': [{'value': '17.90', 'spread': '8.33', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks following surgery to end of treatment at 24 months', 'description': 'Rehabilitation measured by the cumulative number of completed rehabilitation or physical therapy (PT) visits to treat index Achilles.', 'unitOfMeasure': 'visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed indicates participants that provided data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Treatment with Rotation Medical Bioinductive Implant\n\nRotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy'}], 'classes': [{'categories': [{'measurements': [{'value': '167.80', 'spread': '68.04', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'following surgery to end of treatment at 24 months', 'description': 'Recovery will be measured by days to return to normal daily activity (i.e. full, unrestricted activity).', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed indicates participants that provided data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Participant Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Treatment with Rotation Medical Bioinductive Implant\n\nRotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy'}], 'classes': [{'categories': [{'title': 'Very dissatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Dissatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Neither satisfied nor dissatisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Satisfied', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Very satisfied', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Participant Satisfaction will determined based on the response to the statement "I am satisfied with the results of my surgery." The response will be assessed with a 5-point Likert scale, which has 1 - very dissatisfied, 2 - dissatisfied, 3 - neither satisfied nor dissatisfied, 4 - satisfied, 5 - very satisfied', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed that provided data for this outcome measure'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': 'Treatment with Rotation Medical Bioinductive Implant\n\nRotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'There were a total of 20 participants enrolled in the study. The first participant was implanted on 7 June 2016 and the final participant was implanted on 11 August 2017. All participants who were consented and who proceeded to surgery were successfully implanted.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment', 'description': 'Treatment with Rotation Medical Bioinductive Implant\n\nRotation Medical Bioinductive Implant: Placement of bioinductive implant over repair of insertional Achilles tendinopathy'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.60', 'spread': '6.76', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Caucasian', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '68.30', 'spread': '4.50', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'inches', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '213.30', 'spread': '38.58', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pounds (lb)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Study ankle', 'classes': [{'categories': [{'title': 'Left', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Right', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking history', 'classes': [{'categories': [{'title': 'Never', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Former', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Current', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of Achilles pain', 'classes': [{'categories': [{'measurements': [{'value': '18.10', 'spread': '11.92', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-02-12', 'size': 996286, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-08-24T13:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-10', 'studyFirstSubmitDate': '2016-06-14', 'resultsFirstSubmitDate': '2022-07-26', 'studyFirstSubmitQcDate': '2016-06-20', 'lastUpdatePostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-10', 'studyFirstPostDateStruct': {'date': '2016-06-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'New Tissue Thickness', 'timeFrame': '3, 12, and 24 months', 'description': 'Measurement of new tissue thickness in millimeters will be made from sagittal magnetic resonance imaging (MRI) at the level of the bone anchor. These measurements were made distal to the attachment of the Achilles tendon, which do not include the thickness of the repaired tendon; therefore, these thicknesses represent the thickness of the newly induced tissue only.'}, {'measure': 'MRI Measurements of Tendon Thickening (Combined Tendon and New Tissue)', 'timeFrame': '3, 12, and 24 months', 'description': 'Combined measurement of tendon and new tissue thickness in millimeters will be made from sagittal magnetic resonance imaging (MRI) at the insertion (approximately 5-10mm proximal to the bone anchor).'}, {'measure': 'Tear Rate', 'timeFrame': 'following surgery to end of treatment at 24 months', 'description': 'Tear rate in the deep portion of the repair at the calcaneus following Achilles surgery will be assessed at each follow-up visit using magnetic resonance imaging (MRI).'}], 'secondaryOutcomes': [{'measure': 'Device Implant Time', 'timeFrame': 'Intraoperatively, up to 9 minutes', 'description': 'Time in minutes from introduction of the bioinductive implant into the surgical field to completion of the last staple'}, {'measure': 'Number of Participants With Procedure Technical Success', 'timeFrame': 'Intraoperatively, up to 9 minutes', 'description': 'The number of participants where the device was successfully delivered and affixed to target tendon location (i.e., study device was successfully implanted).'}, {'measure': 'CAM Boot Time', 'timeFrame': '1 week following surgery to 12 months', 'description': 'Cumulative number of days spent in a controlled ankle motion walking boot (CAM boot).'}, {'measure': 'Rehabilitation Visits', 'timeFrame': '4 weeks following surgery to end of treatment at 24 months', 'description': 'Rehabilitation measured by the cumulative number of completed rehabilitation or physical therapy (PT) visits to treat index Achilles.'}, {'measure': 'Time to Recovery', 'timeFrame': 'following surgery to end of treatment at 24 months', 'description': 'Recovery will be measured by days to return to normal daily activity (i.e. full, unrestricted activity).'}, {'measure': 'Participant Satisfaction', 'timeFrame': '12 months', 'description': 'Participant Satisfaction will determined based on the response to the statement "I am satisfied with the results of my surgery." The response will be assessed with a 5-point Likert scale, which has 1 - very dissatisfied, 2 - dissatisfied, 3 - neither satisfied nor dissatisfied, 4 - satisfied, 5 - very satisfied'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Insertional Achilles'], 'conditions': ['Tendinopathy']}, 'descriptionModule': {'briefSummary': 'To evaluate bioinduction of new tissue and tendon healing after implantation of the Rotation Medical Bioinductive Implant used as adjunct to surgical repair in the treatment of insertional Achilles tendonitis.', 'detailedDescription': 'This is a prospective, non-randomized, single-arm study conducted under a common protocol designed to evaluate long-term outcomes following open treatment and implantation of the Rotation Medical Bioinductive Implant to treat insertional Achilles tendinopathy.\n\nUp to 20 subjects will be enrolled and treated with the Rotation Medical Bioinductive Implant.\n\nEnrollment is anticipated to take up to 12 months and all subjects will be followed for two years after surgery. Therefore, the overall study duration is estimated to be 36 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. At least 21 years of age\n2. Insertional Achilles tendonitis requiring surgery that has failed conservative management, which consist of:\n\n A. Shoe modification B. Nonsteroidal anti-inflammatory drugs C. Physical Therapy with/without modalities\n3. Chronic Achilles tendon pain lasting longer than 3 months\n4. MRI or X-ray of the ankle within 60 days prior to the study procedure\n5. Willing to comply with the prescribed post-operative rehabilitation program\n6. Willing to be available for each protocol-required follow-up examination\n7. Able to understand the informed consent process, including regulatory requirements such as HIPAA authorization, and document informed consent prior to completion of any study-related procedures\n8. Ability to read, understand, and complete subject-reported outcomes in English\n\nExclusion Criteria:\n\n1. Achilles tendon rupture\n2. Previous Achilles tendon surgery on the index ankle\n3. Genetic collagen disease\n4. History of auto-immune or immunodeficiency disorders\n5. History of chronic inflammatory disorders\n6. Oral steroid use in last 2 months or injectable steroid use in last 4 weeks\n7. History of heavy smoking (\\> 1 pack per day) within last 6 months\n8. Hypersensitivity to bovine-derived materials\n9. Hypersensitivity to Polylactic Acid (PLA) and Polyetheretherketone (PEEK) materials\n10. Metal implants, fillings, shrapnel, and/or screws\n11. Females of child-bearing potential who are pregnant or plan to become pregnant during the course of the study\n12. Currently involved in any injury litigation or worker's compensation claims relating to the index ankle\n13. Enrolled, or plans to enroll, in another clinical trial during this study that would affect the outcomes of this study\n14. History of non-compliance with medical treatment, physical therapy/rehabilitation, or clinical study participation\n15. History of cognitive or mental health status that interferes with study participation"}, 'identificationModule': {'nctId': 'NCT02811003', 'briefTitle': 'Achilles Tendon Repair With Bioinductive Implant', 'organization': {'class': 'INDUSTRY', 'fullName': 'Smith & Nephew, Inc.'}, 'officialTitle': 'Evaluation of the Rotation Medical Bioinductive Implant for Insertional Achilles Tendinopathy', 'orgStudyIdInfo': {'id': '3672-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Treatment with Rotation Medical Bioinductive Implant', 'interventionNames': ['Device: Rotation Medical Bioinductive Implant']}], 'interventions': [{'name': 'Rotation Medical Bioinductive Implant', 'type': 'DEVICE', 'description': 'Placement of bioinductive implant over repair of insertional Achilles tendinopathy', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21218', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'MedStar Union Memorial Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny Health Network', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Gregory P Guyton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MedStar Union Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Smith & Nephew, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}