Capsular Repair in FAI Impingement Surgery

NCT02990234 | Completed

• 1 other identifier: 13-2310
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hip Injuries

Keywords

Capsular Repair; FAI; Hip

Outcome Measures

Primary Outcomes (1)

• Change in iHOT Version 12

  Baseline, 6weeks, 12weeks, 6months, 1Year, 2Years

Other Outcomes (4)

• Change in Marx activity score

  Baseline, 6weeks, 12weeks, 6months, 1Year, 2Years

• Change in Range of Motion

  Baseline, 14days, 6weeks, 12weeks, 6months, 1Year, 2Years

• Change in X-rays

  6weeks, 6months, 1Year

Study Arms (2)

Capsular Repair

ACTIVE COMPARATOR

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.

Procedure: Capsular Repair

No Capsular Repair

PLACEBO COMPARATOR

Placebo arm. One hip is randomized to capsular repair while the other hip has no capsular repair.

Procedure: No Capsular Repair

Interventions

Capsular Repair PROCEDURE

Capsular Repair

No Capsular Repair PROCEDURE

No Capsular Repair

Eligibility Criteria

• Age: 16 Years - 51 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female patients aged between 16-51 years of age.
• Healthy patients undergoing hip arthroscopy due to Cam or mixed FAI
• No major osteoarthritic (OA) changes according to X-Ray and surgery observation (Tonnis 0-1)
• No previous hip surgery
• No other influential disabilities in lower limbs
• No chronic use of NSAID, analgesics, steroids or chemotherapy drugs
• Base line activity level (Tegner 3 and above)

You may not qualify if:

• Patients with concomitant disease that may affect joints
• Patients with major ligamentous laxity
• Patients who have undergone only minor vertical capsulotomy (as in small pincer only lesions)
• Patients with extreme range of motion needs (such as ballet dancers)
• Patients suffering from connective tissue disease
• Patients suffering from bilateral symptomatic FAI that are being operated on for their first hip
• 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
• Patients who needed Ilio-Psoas release
• Patients whose cartilage hip status was defined as advanced OA during surgery
• Patients who following surgery would be instructed to avoid full weight bearing on the operated hip for more than 4 weeks
• Concomitant use of PRP (platelet rich plasma) or hyaluronic acid during the surgical procedure
• Patients with preoperative hip stiffness

Sponsors & Collaborators

• University of Colorado, Denver: lead

Related Publications (8)

• 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: 20678712 BACKGROUND

• 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: 16822891 BACKGROUND

• 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: 16638493 BACKGROUND

• 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: 16376242 BACKGROUND

• 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: 19122095 BACKGROUND

• 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: 19341927 BACKGROUND

• 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: 19341928 BACKGROUND

• 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.

  PMID: 18442685 BACKGROUND

MeSH Terms

Conditions

Hip Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Omer Mei-Dan, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 13, 2016
• Study Start: March 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: December 2, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share