Capsular Repair in FAI Impingement Surgery

The Efficacy of Capsular Repair in Arthroscopic Femoroacetabular

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.

Study Overview

• Status: Completed
• Conditions: Hip Injuries
• Intervention / Treatment: Procedure: Capsular Repair; Procedure: No Capsular Repair

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 51 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with concomitant disease that may affect joints
2. Patients with major ligamentous laxity
3. Patients who have undergone only minor vertical capsulotomy (as in small pincer only lesions)
4. Patients with extreme range of motion needs (such as ballet dancers)
5. Patients suffering from connective tissue disease
6. Patients suffering from bilateral symptomatic FAI that are being operated on for their first hip
7. 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
8. Patients who needed Ilio-Psoas release
9. Patients whose cartilage hip status was defined as advanced OA during surgery
10. Patients who following surgery would be instructed to avoid full weight bearing on the operated hip for more than 4 weeks
11. Concomitant use of PRP (platelet rich plasma) or hyaluronic acid during the surgical procedure
12. Patients with preoperative hip stiffness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Capsular Repair; 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
Placebo Comparator: No Capsular Repair; Placebo arm. One hip is randomized to capsular repair while the other hip has no capsular repair.	Procedure: No Capsular Repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in iHOT Version 12	Baseline, 6weeks, 12weeks, 6months, 1Year, 2Years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	6weeks, 6months, 1Year
Change in MRI	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.	6weeks, 6months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver

Publications and helpful links

General Publications

• 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.
• Byrd JW. Hip arthroscopy. J Am Acad Orthop Surg. 2006 Jul;14(7):433-44. doi: 10.5435/00124635-200607000-00006. No abstract available.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: December 5, 2016
• First Submitted That Met QC Criteria: December 8, 2016
• First Posted (Estimate): December 13, 2016

Study Record Updates

• Last Update Posted (Actual): December 2, 2017
• Last Update Submitted That Met QC Criteria: November 29, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Hip; FAI; Capsular Repair
• Additional Relevant MeSH Terms: Wounds and Injuries; Hip Injuries
• Other Study ID Numbers: 13-2310

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO