The Purpose of This Pilot Study is to Determine Feasibility of a Randomized Controlled Trial Comparing Labral Repair Versus Reconstruction in Patients Over 40 Years of Age Undergoing Hip Arthroscopy for FAIS.

Labral Repair Versus Reconstruction in Symptomatic Femoroacetabular Impingement in Patients Over 40 Years of Age - A Randomized Controlled Trial

The purpose of this pilot study is to determine feasibility of a randomized controlled trial comparing labral repair versus reconstruction in patients over 40 years of age undergoing hip arthroscopy for FAIS. Specifically, we aim to: (1) estimate the proportion of eligible patients providing consent, (2) estimate the magnitude of the between-groups difference in the primary outcome (International Hip Outcome Tool [iHOT] - 33) to aid in sample size calculation for the full study, (3) estimate the compliance in completing the proposed outcome measures to determine the burden of questionnaire completion.

Study Overview

• Status: Not yet recruiting
• Conditions: Femoral Acetabular Impingement
• Intervention / Treatment: Procedure: Labral Repair; Procedure: Labral Reconstruction

Detailed Description

Femoroacetabular impingement syndrome (FAIS) is an increasingly common cause hip pain1. It is known to cause labral pathology and if left untreated, can also contribute to the development of hip osteoarthritis2. While non-operative treatment has been shown to be effective and can improve patients' quality of life, surgical treatment has often been shown to yield superior outcomes, while also potentially decreasing the future risk of osteoarthritis3,4,5,6.

Mid- to long-term outcomes have shown durable results following hip arthroscopy with significant improvements in patient reported outcome measures (PROMs)7,8. Consequently, hip arthroscopy utilization has continued to increase. Several retrospective cohort studies have attempted to identify prognostic variables associated with procedural outcomes9-11. In terms of patient selection, age has historically been identified as a negative prognostic variable, with inferior clinical outcomes observed in patients over the age of 4012,13. However, more recent studies have disputed this finding, suggesting that earlier studies reporting this included patients with concomitant hip osteoarthritis, which was more to blame than their chronological age. Recent case series have reported significant improvements in PROMs in patients over the age of 40 who have minimal concomitant OA (Tönnis 0 or 1), with durable results out to 5 years14-16.

Despite these encouraging results, newer concerns have been raised when it comes to labral treatment in this demographic. It has been suggested that in patients over 40 years of age, the labrum may be too traumatized to allow repair or that it may have diminished healing capacity from repetitive impingement or age-related degeneration 17,18 . As such, there have been proponents of performing a primary labral reconstruction in this patient population, with better associated outcomes18. Others have reported equivocal outcomes between repair and reconstruction for this group19. As such, there is no consensus on the best treatment strategy to manage these patients.

The results of this pilot study will allow us to determine whether a full-scale study will be feasible. We will not move forward with the full study: 1) if the proportion of eligible patients providing consent is <80%; 2) If the 95% confidence intervals around the difference between groups does not include even the possibility of a small, but important effect (0.2 SD); 3) if the proportion of patients completing their one-year follow-up is <85%, then the study is not feasible.

Ultimately, for the full-scale study, we hypothesize that patients treated with labral reconstruction will have significantly better outcome scores compared with patients who underwent a traditional labral repair. If the hypothesized findings are true in the full study, this will change clinical practice patterns by providing objective evidence to guide treatment of labral pathology in patients over the age of 40 undergoing hip arthroscopy for FAIS.

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 3K7
      • Fowler Kennedy Sport Medicine Clinic
      • Contact: Ashley Ambrose; Phone Number: 87528 5196612111; Email: ashley.ambrose@lhsc.on.ca
      • Principal Investigator: Ryan Degen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion:

-Cam or pincer morphology who have failed a trial of conservative treatment

Exclusion:

• Moderate concomitant OA (Tönnis 2+)
• Have had previous hip surgery
• Active joint or systemic infection
• Significant muscle paralysis
• Inflammatory arthropathies
• Significant medical comorbidity that may alter effectiveness of surgical intervention
• Active smoker
• Major medical illness
• Unable to speak and understand English
• Psychiatric illness that precludes informed consent
• Unwilling to be followed for 2 years

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Labral Repair; Standard arthroscopic osteochondroplasty and concomitant labral repair, using a minimum of two suture anchors.	Procedure: Labral Repair; Standard arthroscopic osteochondroplasty and concomitant labral repair, using a minimum of two suture anchors.
Active Comparator: Labral Reconstruction; Standard arthroscopic osteochondroplasty and subsequent labral reconstruction with allograft.	Procedure: Labral Reconstruction; Standard arthroscopic osteochondroplasty and subsequent labral reconstruction with allograft.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
International Hip Outcome Tool (iHOT) - 12	Baseline to 2 years post surgical follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Hip Outcome Score- Activities of Daily Living (HOS-ADL)	Baseline to 2 years post surgical follow-up
Hip Outcome Score- Sport Specific Subscale (HOS-SSS)	Baseline to 2 years post surgical follow-up
modified Harris Hip Score (mHHS)	Baseline to 2 years post surgical follow-up
EQ-5D	Baseline to 2 years post surgical follow-up
Cost Diary	6 weeks to 2 years post surgical follow-up
Patient Satisfaction Scale	6 weeks to 2 years post surgical follow-up
Post-operative complication rates	6 weeks to 2 years post surgical follow-up
Subsequent surgery rates	6 weeks to 2 years post surgical follow-up

Collaborators and Investigators

• Sponsor: Western University, Canada

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: May 19, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: labral repair; labral reconstruction
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathologic Processes; Joint Diseases; Pathological Conditions, Signs and Symptoms; Femoracetabular Impingement
• Other Study ID Numbers: 127777

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No