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Capsular Repair in FAI Impingement Surgery

Primary Purpose

Hip Injuries

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Capsular Repair

No Capsular Repair

About this trial

This is an interventional treatment trial for Hip Injuries focused on measuring Capsular Repair, FAI, Hip

Eligibility Criteria

16 Years - 51 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Capsular Repair

No Capsular Repair

Arm 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.

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

Outcomes

Primary Outcome Measures

Change in iHOT Version 12

Secondary Outcome Measures

Full Information

NCT ID

NCT02990234

First Posted

December 5, 2016

Last Updated

November 29, 2017

Sponsor

University of Colorado, Denver

1. Study Identification

Unique Protocol Identification Number

NCT02990234

Brief Title

Capsular Repair in FAI Impingement Surgery

Official Title

The Efficacy of Capsular Repair in Arthroscopic Femoroacetabular

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

March 2014 (Actual)

Primary Completion Date

October 2017 (Actual)

Study Completion Date

October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Colorado, Denver

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hip Injuries

Keywords

Capsular Repair, FAI, Hip

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Capsular Repair

Arm Type

Active Comparator

Arm 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.

Arm Title

No Capsular Repair

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Capsular Repair

Intervention Type

Procedure

Intervention Name(s)

No Capsular Repair

Primary Outcome Measure Information:

Title

Change in iHOT Version 12

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Change in Marx activity score

Time Frame

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

Title

Change in Range of Motion

Time Frame

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

Title

Change in X-rays

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.

Time Frame

6weeks, 6months, 1Year

Title

Change in MRI

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.

Time Frame

6weeks, 6months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

51 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Omer Mei-Dan, MD

Organizational Affiliation

University of Colorado, Denver

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

20678712

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.

Results Reference

background

PubMed Identifier

16822891

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.

Results Reference

background

PubMed Identifier

16638493

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.

Results Reference

background

PubMed Identifier

16376242

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.

Results Reference

background

PubMed Identifier

19122095

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.

Results Reference

background

PubMed Identifier

19341927

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.

Results Reference

background

PubMed Identifier

19341928

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.

Results Reference

background

PubMed Identifier

18442685

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.

Results Reference

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Capsular Repair in FAI Impingement Surgery

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