- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01623843
Femoroacetabular Impingement RandomiSed Controlled Trial (FIRST)
Femoroacetabular Impingement RandomiSed Controlled Trial (FIRST); Sub-study: Femoroacetabular Impingement RandomiSed Controlled Trial With an Embedded Prospective Cohort (FIRST-EPIC)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Femoroacetabular impingement (FAI) is a condition of the hip where there is a mismatch of the ball and socket in the hip joint. This mismatch creates abnormal contact in the hip which can cause patients to experience hip pain. This can eventually lead to hip damage and osteoarthritis. Hip arthroscopy, a form of minimally invasive surgery has become a popular treatment option. The investigators are conducting a definitive randomized controlled trial (RCT) to determine whether surgical correction of the impingement morphology via arthroscopic osteochondroplasty (shaving of bone) will provide improved clinical results (decreased pain and improved function) in adult FAI patients compared to arthroscopic lavage (washing out of painful inflammation debris) and treating obvious damage of the hip joint.
Like most RCTs, FIRST is designed to demonstrate efficacy (i.e. that an intervention can work theoretically under optimal conditions). In order to address generalizability and improve external validity of the FIRST trial, we are including an external validation cohort using a "RCT with and Embedded ProspectIve Cohort design" (FIRST-EPIC). This pragmatic cohort will allow us to: 1) safeguard against bias attributable to patients declining to take part in the RCT; 2) corroborate or refute whether our efficacy (RCT) population represents the best case scenario (i.e. those with optimal response to osteochondroplasty); 3) evaluate effectiveness of osteochondroplasty and other standard of care treatments for FAI in patients with potentially distinct prognostic factors; and 4) evaluate the cost-effectiveness of the interventions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Nova Scotia
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Halifax, Nova Scotia, Canada
- Dalhousie University
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Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- McMaster University
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Kingston, Ontario, Canada
- Kingston General Hospital
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London, Ontario, Canada
- London Health Sciences
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London, Ontario, Canada
- Fowler Kennedy Sports Medicine Clinic
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Toronto, Ontario, Canada
- St. Michael's Hospital
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Quebec
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Quebec City, Quebec, Canada
- CHU de Québec, L'Hôtel-Dieu de Québec
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Odense, Denmark
- Odense University Hospital
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Tampere, Finland, 33900
- Hatanpää Hospital
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Turku, Finland, 20540
- Turku University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult men or women ages 18 to 50 years
- Hip pain for greater than 6 months with no relief from non-operative means (physiotherapy, non-steroidal anti-inflammatory medication, rest)
- Documentation of failed physiotherapy, including core conditioning of the hip, back, and abdomen
- CAM or Mixed Type FAI as diagnosed on x-rays and magnetic resonance imaging (MRI) or magnetic resonance arthrogram (MRA)
- Temporary relief from an intra-articular hip injection
- Informed consent from participant
- Ability to speak, understand and read in the language of the clinical site
Exclusion Criteria:
- Previous inclusion in a study involving FAI
- Evidence of hip dysplasia (centre edge angle less than 20)
- Presence of advanced hip osteoarthritis (Tonnis Grade 2 or 3)
- Presence of other hip syndromes (concurrent non-FAI related pathology)
- Previous trauma to the affected hip
- Previous surgery on the affected hip or contralateral hip
- Severe acetabular deformities (e.g. acetabular protrusion, coxa profunda, circumferential labral ossification)
- Immunosuppressive medication use
- Chronic pain syndromes
- Significant medical co-morbidities (requiring daily assistance for ADLs)
- History of paediatric hip disease (Legg-Calve-Perthes; slipped capital femoral epiphysis)
- Ongoing litigation or compensation claims secondary to hip problems
Any other reasons given to exclude the patient
- If a patient does not meet the eligibility criteria for the FIRST trial, they may be considered eligible for the FIRST-EPIC sub-study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Arthroscopic Lavage
Participants have three hip portals (antero-lateral, mid anterior, distal antero-lateral) with limited capsulotomy allowing for a complete assessment of the central and peripheral compartments.
The participant has a diagnostic arthroscopy and lavage of the hip joint with three litres of normal saline.
No osteochondroplasty or rim resection is completed in this group.
No instruments are used to treat minor cartilage or labral damage.
The labrum should only be repaired if mechanically unstable once probed with visible displacement or chondrolabral separation.
The labrum will be refixated only if the above criteria for labral instability is met.
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Lavage: inflammation debris caused from continual friction in the hip is washed out.
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Experimental: Arthroscopic Osteochondroplasty
After establishing standard portals, an inter-portal capsulotomy will be completed to allow for complete evaluation of the central compartment of the hip.
Significant and obvious labral tears and cartilage damage will be addressed.
The labrum will be repaired if mechanically unstable once probed with visible displacement or chondrolabral separation.
The acetabular rim will be evaluated and any evident Pincer lesion will be resected using an arthroscopic burr under fluoroscopic guidance.
Following this resection, the labrum will be refixated only if the criteria for labral instability is met.
Following this, a limited capsulotomy will be completed along the head-neck junction of the femoral neck to allow for visualization and treatment of the impingement lesion in the peripheral compartment.
For the FIRST-EPIC sub-study, participants will receive the osteochondroplasty intervention as per standard of care.
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Osteochondroplasty: reshaping the hip ball and socket ("osteoplasty" or "rim trimming").
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Pain (measured using a Visual Analog Scale)
Time Frame: 12 months
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The VAS is one of the most frequently used pain rating scales in clinical practice and research.
The VAS is a validated unidimensional scale that is easy to use, requires no verbal or reading skills, and is sufficiently versatile to be employed in a variety of settings.
The VAS will be administered during routine follow up visits at baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 12 months.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Function (measured using the Hip Outcome Score)
Time Frame: 12 months
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The HOS is a self-administered hip score that was designed to capture hip function and outcomes following surgical therapies such as arthroscopy.
The HOS has been shown to have the greatest clinimetric evidence for use in patients with FAI or labral tears.
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12 months
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Health-related quality of life (measured using the Short-Form 12)
Time Frame: 12 months
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The SF-12 may be self or interview-administered and will help document general health status as well as the burden of illness that FAI presents.
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12 months
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Function and lifestyle (measured using the International Hip Outcome Tool)
Time Frame: 12 months
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The iHOT-12 is a shorter version of the iHOT-33 designed to be easier to complete in routine clinical practice to measure both health-related quality of life and changes after treatment in young, active patients with hip disorders.
This questionnaire has been shown to be valid, reliable, and responsive to change.
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12 months
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Health utility (measured using the Euro-Quol 5 Dimensions)
Time Frame: 12 months
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The EQ-5D is a standardized instrument for use as a measure of health outcome.
The EQ-5D comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).
The EQ-5D has been used in previous studies involving patients with hip pain and has been extensively validated.
Our decision to the use EQ-5D was based upon our interest in collecting health utility data for a formal economic analysis.
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12 months
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Urinary function (measured using the Male/Female Lower Urinary Tract Symptoms questionnaires)
Time Frame: 12 months
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The two validated questionnaires selected that pertain to male and female urinary symptoms are gender specific variations of the International Consultation on Continence Questionnaire (ICIQ).
The ICIQ-MLUTS (male) and ICIQ-FLUTS (female).
These are validated patient-completed questionnaires, which evaluate male and female lower urinary tract symptoms (LUTS), as well as quality of life.
Both questionnaires have demonstrated validity, reliability and responsiveness internally and externally.
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12 months
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Sexual function (measured using the International Index of Erectile Dysfunction and the Female Sexual Function Index)
Time Frame: 12 months
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The FSFI is a brief psychometrically sound and reliable tool that assesses female sexual function, and has proven ability to discriminate between clinical and nonclinical populations.The FSFI is also designed to measure the impact on quality of life.
The IIEF is a brief self-administered questionnaire assessing sexual experience within the previous 4 weeks, consisting of 15 questions designed to address 5 relevant aspects of male sexual function, specifically erectile function, sexual desire, orgasmic function, intercourse satisfaction and overall satisfaction.
This instrument is psychometrically sound with high sensitivity and specificity, which has been validated for administration in research and clinical settings, and across cultures with linguistically validated versions.
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12 months
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Complications / Adverse events
Time Frame: 12 and 24 months
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Includes additional surgery, infection, reduced range of motion, and other adverse events
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12 and 24 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Olufemi Ayeni, MD, MSc, FRCSC, McMaster Univerity
Publications and helpful links
General Publications
- Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
- Ganz R, Parvizi J, Beck M, Leunig M, Notzli H, Siebenrock KA. Femoroacetabular impingement: a cause for osteoarthritis of the hip. Clin Orthop Relat Res. 2003 Dec;(417):112-20. doi: 10.1097/01.blo.0000096804.78689.c2.
- Philippon MJ, Stubbs AJ, Schenker ML, Maxwell RB, Ganz R, Leunig M. Arthroscopic management of femoroacetabular impingement: osteoplasty technique and literature review. Am J Sports Med. 2007 Sep;35(9):1571-80. doi: 10.1177/0363546507300258. Epub 2007 Apr 9.
- Clohisy JC, Carlisle JC, Beaule PE, Kim YJ, Trousdale RT, Sierra RJ, Leunig M, Schoenecker PL, Millis MB. A systematic approach to the plain radiographic evaluation of the young adult hip. J Bone Joint Surg Am. 2008 Nov;90 Suppl 4(Suppl 4):47-66. doi: 10.2106/JBJS.H.00756. No abstract available.
- Bedi A, Chen N, Robertson W, Kelly BT. The management of labral tears and femoroacetabular impingement of the hip in the young, active patient. Arthroscopy. 2008 Oct;24(10):1135-45. doi: 10.1016/j.arthro.2008.06.001.
- Christensen CP, Althausen PL, Mittleman MA, Lee JA, McCarthy JC. The nonarthritic hip score: reliable and validated. Clin Orthop Relat Res. 2003 Jan;(406):75-83. doi: 10.1097/01.blo.0000043047.84315.4b.
- Lincoln M, Johnston K, Muldoon M, Santore R. Combined arthroscopic and modified open approach for cam femoroacetabular impingement: a preliminary experience. Arthroscopy. 2009 Apr;25(4):392-9. doi: 10.1016/j.arthro.2008.12.002.
- Larson CM, Giveans MR. Arthroscopic management of femoroacetabular impingement: early outcomes measures. Arthroscopy. 2008 May;24(5):540-6. doi: 10.1016/j.arthro.2007.11.007. Epub 2008 Jan 7.
- Ng VY, Arora N, Best TM, Pan X, Ellis TJ. Efficacy of surgery for femoroacetabular impingement: a systematic review. Am J Sports Med. 2010 Nov;38(11):2337-45. doi: 10.1177/0363546510365530. Epub 2010 May 20.
- Botser IB, Smith TW Jr, Nasser R, Domb BG. Open surgical dislocation versus arthroscopy for femoroacetabular impingement: a comparison of clinical outcomes. Arthroscopy. 2011 Feb;27(2):270-8. doi: 10.1016/j.arthro.2010.11.008.
- Tannast M, Siebenrock KA, Anderson SE. Femoroacetabular impingement: radiographic diagnosis--what the radiologist should know. AJR Am J Roentgenol. 2007 Jun;188(6):1540-52. doi: 10.2214/AJR.06.0921.
- Anderson SE, Siebenrock KA, Mamisch TC, Tannast M. Femoroacetabular impingement magnetic resonance imaging. Top Magn Reson Imaging. 2009 Jun;20(3):123-8. doi: 10.1097/RMR.0b013e3181d99459.
- Notzli HP, Wyss TF, Stoecklin CH, Schmid MR, Treiber K, Hodler J. The contour of the femoral head-neck junction as a predictor for the risk of anterior impingement. J Bone Joint Surg Br. 2002 May;84(4):556-60. doi: 10.1302/0301-620x.84b4.12014.
- Schenker ML, Martin R, Weiland DE, Philippon MJ. Current trends in hip arthroscopy: a review of injury diagnosis, techniques and outcome scoring. Current opinion in orthopeadics.2005;16:89-94.
- Thorborg K, Roos EM, Bartels EM, Petersen J, Holmich P. Validity, reliability and responsiveness of patient-reported outcome questionnaires when assessing hip and groin disability: a systematic review. Br J Sports Med. 2010 Dec;44(16):1186-96. doi: 10.1136/bjsm.2009.060889. Epub 2009 Aug 6.
- Lodhia P, Slobogean GP, Noonan VK, Gilbart MK. Patient-reported outcome instruments for femoroacetabular impingement and hip labral pathology: a systematic review of the clinimetric evidence. Arthroscopy. 2011 Feb;27(2):279-86. doi: 10.1016/j.arthro.2010.08.002. Epub 2010 Oct 29.
- Kay J, Simunovic N, Ayeni OR; FIRST Investigators, Bhandari M, Bedi A, Jarvinen T, Musahl V, Naudie D, Seppanen M, Slobogean G, Thabane L, Duong A, Skelly M, Shanmugaraj A, Crouch S, Sprague S, Heels-Ansdell D, Buckingham L, Ramsay T, Lee J, Kousa P, Carsen S, Choudur H, Sim Y, Johnston K, Wong I, Murphy R, Sparavalo S, Whelan D, Khan R, Wood GCA, Howells F, Grant H, Zomar B, Pollock M, Willits K, Firth A, Wanlin S, Remtulla A, Kaniki N, Belzile EL, Turmel S, Jorgensen U, Gam-Pedersen A, Sihvonen R, Raivio Sihvonen M, Toivonen Sihvonen P, Pirjetta Routapohja M. Effect of Osteochondroplasty on Time to Reoperation After Arthroscopic Management of Femoroacetabular Impingement: Analysis of a Randomized Controlled Trial. Orthop J Sports Med. 2022 Apr 5;10(4):23259671211041400. doi: 10.1177/23259671211041400. eCollection 2022 Apr.
- Femoroacetabular Impingement Randomized Controlled Trial (FIRST) Investigators, Ayeni OR, Karlsson J, Heels-Ansdell D, Thabane L, Musahl V, Simunovic N, Duong A, Bhandari M, Bedi A, Jarvinen T, Naudie D, Seppanen M, Slobogean G, Skelly M, Shanmugaraj A, Crouch S, Sprague S, Buckingham L, Ramsay T, Lee J, Kousa P, Carsen S, Choudur H, Sim Y, Johnston K, Sprague S, Wong I, Murphy R, Sparavalo S, Whelan D, Khan R, Wood GCA, Howells F, Grant H, Naudie D, Zomar B, Pollock M, Willits K, Firth A, Wanlin S, Remtulla A, Kaniki N, Belzile EL, Turmel S, Jorgensen U, Gam-Pedersen A, Hatanpaa T, Sihvonen R, Raivio M, Toivonen P, Routapohja MP. Osteochondroplasty and Labral Repair for the Treatment of Young Adults With Femoroacetabular Impingement: A Randomized Controlled Trial. Am J Sports Med. 2021 Jan;49(1):25-34. doi: 10.1177/0363546520952804. Epub 2020 Sep 24.
- Simunovic N, Heels-Ansdell D, Thabane L, Ayeni OR; FIRST Investigators. Femoroacetabular Impingement Randomised controlled Trial (FIRST) - a multi-centre randomized controlled trial comparing arthroscopic lavage and arthroscopic osteochondroplasty on patient important outcomes and quality of life in the treatment of young adult (18-50 years) femoroacetabular impingement: a statistical analysis plan. Trials. 2018 Oct 29;19(1):588. doi: 10.1186/s13063-018-2965-0.
- FIRST Investigators. A multi-centre randomized controlled trial comparing arthroscopic osteochondroplasty and lavage with arthroscopic lavage alone on patient important outcomes and quality of life in the treatment of young adult (18-50) femoroacetabular impingement. BMC Musculoskelet Disord. 2015 Mar 20;16:64. doi: 10.1186/s12891-015-0500-y.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FIRST-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Femoroacetabular Impingement
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Ottawa Hospital Research InstituteCompleted
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Schulthess KlinikCompletedSymptomatic Femoroacetabular ImpingementSwitzerland
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Ottawa Hospital Research InstituteCompletedFemoroacetabular Hip Impingement SyndromeCanada
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Ramsay Générale de SantéRamsay santéRecruiting
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Horsens HospitalUniversity of Aarhus; La Trobe UniversityNot yet recruitingFemoroacetabular Impingement
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American Hip InstituteStryker OrthopaedicsRecruitingFemoroacetabular ImpingementUnited States
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Hospital for Special Surgery, New YorkNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)RecruitingFemoroacetabular ImpingementUnited States
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Universitaire Ziekenhuizen KU LeuvenActive, not recruitingFemoroacetabular ImpingementBelgium
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McMaster UniversityCanadian Institutes of Health Research (CIHR); McMaster Surgical Association; Arthroscopy Association of North America and other collaboratorsActive, not recruitingFemoroacetabular ImpingementCanada, Netherlands, Korea, Republic of
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The Hawkins FoundationTerminated
Clinical Trials on Arthroscopic Lavage
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CM Chungmu HospitalCompletedRotator Cuff SyndromeKorea, Republic of
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The Affiliated Hospital of Qingdao UniversityCompletedRotator Cuff TearsChina
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Ain Shams UniversityNot yet recruitingHip Injuries | Femoro Acetabular Impingement | Acetabular Labral TearEgypt
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University Hospital, AkershusOslo University Hospital; Diakonhjemmet Hospital; Haukeland University Hospital; Alesund Hospital and other collaboratorsCompleted
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US Department of Veterans AffairsCompleted
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Peking University Third HospitalNot yet recruitingCruciate Ligament RuptureChina
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Pei-Yuan Lee, MDAeon Biotechnology CorporationUnknown
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University of Colorado, DenverCompletedPain, Postoperative | Femoro Acetabular ImpingementUnited States