Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-02-27 @ 10:05 AM
Study NCT ID:
NCT02990234
Status:
COMPLETED
Last Update Posted:
2017-12-02
First Post:
2016-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Capsular Repair in FAI Impingement Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D025981', 'term': 'Hip Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-29', 'studyFirstSubmitDate': '2016-12-05', 'studyFirstSubmitQcDate': '2016-12-08', 'lastUpdatePostDateStruct': {'date': '2017-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Marx activity score', 'timeFrame': 'Baseline, 6weeks, 12weeks, 6months, 1Year, 2Years'}, {'measure': 'Change in Range of Motion', 'timeFrame': 'Baseline, 14days, 6weeks, 12weeks, 6months, 1Year, 2Years'}, {'measure': 'Change in X-rays', 'timeFrame': '6weeks, 6months, 1Year', 'description': 'XR will be used for initial evaluation and for post op resection assessment and long-term OA changes. X-rays will be done post-operatively at 6 weeks, 6 months and 1 year time-frames. All these x-rays are normally performed as standard of care.'}, {'measure': 'Change in MRI', 'timeFrame': '6weeks, 6months', 'description': 'MRI will be conducted at 6 weeks and 6 months post op to evaluate capsular healing status (primary radiological outcome measure), intra articular adhesions, extra articular scarring, labrum/cartilage status and resection assessment. This MRI will be paid by department funds.'}], 'primaryOutcomes': [{'measure': 'Change in iHOT Version 12', 'timeFrame': 'Baseline, 6weeks, 12weeks, 6months, 1Year, 2Years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Capsular Repair', 'FAI', 'Hip'], 'conditions': ['Hip Injuries']}, 'referencesModule': {'references': [{'pmid': '20678712', 'type': 'BACKGROUND', 'citation': 'Bowman KF Jr, Fox J, Sekiya JK. A clinically relevant review of hip biomechanics. Arthroscopy. 2010 Aug;26(8):1118-29. doi: 10.1016/j.arthro.2010.01.027.'}, {'pmid': '16822891', 'type': 'BACKGROUND', 'citation': 'Byrd JW. Hip arthroscopy. J Am Acad Orthop Surg. 2006 Jul;14(7):433-44. doi: 10.5435/00124635-200607000-00006. No abstract available.'}, {'pmid': '16638493', 'type': 'BACKGROUND', 'citation': 'Philippon MJ, Schenker ML. Arthroscopy for the treatment of femoroacetabular impingement in the athlete. Clin Sports Med. 2006 Apr;25(2):299-308, ix. doi: 10.1016/j.csm.2005.12.006.'}, {'pmid': '16376242', 'type': 'BACKGROUND', 'citation': 'Kelly BT, Weiland DE, Schenker ML, Philippon MJ. Arthroscopic labral repair in the hip: surgical technique and review of the literature. Arthroscopy. 2005 Dec;21(12):1496-504. doi: 10.1016/j.arthro.2005.08.013.'}, {'pmid': '19122095', 'type': 'BACKGROUND', 'citation': 'Ranawat AS, McClincy M, Sekiya JK. Anterior dislocation of the hip after arthroscopy in a patient with capsular laxity of the hip. A case report. J Bone Joint Surg Am. 2009 Jan;91(1):192-7. doi: 10.2106/JBJS.G.01367. No abstract available.'}, {'pmid': '19341927', 'type': 'BACKGROUND', 'citation': 'Matsuda DK. Acute iatrogenic dislocation following hip impingement arthroscopic surgery. Arthroscopy. 2009 Apr;25(4):400-4. doi: 10.1016/j.arthro.2008.12.011. Epub 2009 Feb 1.'}, {'pmid': '19341928', 'type': 'BACKGROUND', 'citation': 'Benali Y, Katthagen BD. Hip subluxation as a complication of arthroscopic debridement. Arthroscopy. 2009 Apr;25(4):405-7. doi: 10.1016/j.arthro.2009.01.012.'}, {'pmid': '18442685', 'type': 'BACKGROUND', 'citation': 'Ilizaliturri VM Jr, Byrd JW, Sampson TG, Guanche CA, Philippon MJ, Kelly BT, Dienst M, Mardones R, Shonnard P, Larson CM. A geographic zone method to describe intra-articular pathology in hip arthroscopy: cadaveric study and preliminary report. Arthroscopy. 2008 May;24(5):534-9. doi: 10.1016/j.arthro.2007.11.019. Epub 2008 Feb 1.'}]}, 'descriptionModule': {'briefSummary': "The Investigator's hypothesis is that capsular repair (after CAM or mixed Femoroacetabular Impingement (FAI) surgery) requiring moderate capsulotomy, would result in similar patient outcomes in the short, mid and long term, both clinically and radiographically, compared to those without capsular repair. The objective of this clinical trial is to evaluate the clinical efficacy with regards to pain, range of motion and return to work and activities of daily living. Secondary objective is to evaluate radiographic characteristics between both groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '51 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female patients aged between 16-51 years of age.\n2. Healthy patients undergoing hip arthroscopy due to Cam or mixed FAI\n3. No major osteoarthritic (OA) changes according to X-Ray and surgery observation (Tonnis 0-1)\n4. No previous hip surgery\n5. No other influential disabilities in lower limbs\n6. No chronic use of NSAID, analgesics, steroids or chemotherapy drugs\n7. Base line activity level (Tegner 3 and above)\n\nExclusion Criteria:\n\n1. Patients with concomitant disease that may affect joints\n2. Patients with major ligamentous laxity\n3. Patients who have undergone only minor vertical capsulotomy (as in small pincer only lesions)\n4. Patients with extreme range of motion needs (such as ballet dancers)\n5. Patients suffering from connective tissue disease\n6. Patients suffering from bilateral symptomatic FAI that are being operated on for their first hip\n7. Patients with relative or proven dysplastic hip determined by center edge angle and/or extreme version abnormalities as measured on apical CT/MR cuts and pelvic XR\n8. Patients who needed Ilio-Psoas release\n9. Patients whose cartilage hip status was defined as advanced OA during surgery\n10. Patients who following surgery would be instructed to avoid full weight bearing on the operated hip for more than 4 weeks\n11. Concomitant use of PRP (platelet rich plasma) or hyaluronic acid during the surgical procedure\n12. Patients with preoperative hip stiffness'}, 'identificationModule': {'nctId': 'NCT02990234', 'briefTitle': 'Capsular Repair in FAI Impingement Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'The Efficacy of Capsular Repair in Arthroscopic Femoroacetabular', 'orgStudyIdInfo': {'id': '13-2310'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Capsular Repair', 'description': 'Capsular Repair arm. The first hip is randomized, opposite treatment on second hip. One Hip will receive the capsular repair while the other hip will not.', 'interventionNames': ['Procedure: Capsular Repair']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'No Capsular Repair', 'description': 'Placebo arm. One hip is randomized to capsular repair while the other hip has no capsular repair.', 'interventionNames': ['Procedure: No Capsular Repair']}], 'interventions': [{'name': 'Capsular Repair', 'type': 'PROCEDURE', 'armGroupLabels': ['Capsular Repair']}, {'name': 'No Capsular Repair', 'type': 'PROCEDURE', 'armGroupLabels': ['No Capsular Repair']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Omer Mei-Dan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}