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Completed

NCT Number: NCT02990234

Capsular Repair in FAI Impingement Surgery

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.

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Key information

Conditions

Hip Injuries Wounds and Injuries

Age range

16 year–51 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capsular Repair

Procedure

No Capsular Repair

Procedure

Primary outcomes

  1. Change in iHOT Version 12

    Time frame: Baseline, 6weeks, 12weeks, 6months, 1Year, 2Years

Other outcomes

  1. Change in Marx activity score

    Time frame: Baseline, 6weeks, 12weeks, 6months, 1Year, 2Years

  2. Change in Range of Motion

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

  3. Change in X-rays

    Time frame: 6weeks, 6months, 1Year

    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.

  4. Change in MRI

    Time frame: 6weeks, 6months

    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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

The Efficacy of Capsular Repair in Arthroscopic Femoroacetabular

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 13, 2016
Registry last updated
Dec 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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