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NCT Number: NCT07608237

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.

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fowler Kennedy Sport Medicine Clinic

London, Ontario, N6A 3K7, Canada

Location contact

Ashley Ambrose

CONTACT

[email protected]

5196612111 ext. 87528

Ryan Degen

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Labral Repair

Procedure

Standard arthroscopic osteochondroplasty and concomitant labral repair, using a minimum of two suture anchors.

Labral Reconstruction

Procedure

Standard arthroscopic osteochondroplasty and subsequent labral reconstruction with allograft.

Primary outcomes

  1. International Hip Outcome Tool (iHOT) - 12

    Time frame: Baseline to 2 years post surgical follow-up

Secondary outcomes

  1. Hip Outcome Score- Activities of Daily Living (HOS-ADL)

    Time frame: Baseline to 2 years post surgical follow-up

  2. Hip Outcome Score- Sport Specific Subscale (HOS-SSS)

    Time frame: Baseline to 2 years post surgical follow-up

  3. modified Harris Hip Score (mHHS)

    Time frame: Baseline to 2 years post surgical follow-up

  4. EQ-5D

    Time frame: Baseline to 2 years post surgical follow-up

  5. Cost Diary

    Time frame: 6 weeks to 2 years post surgical follow-up

  6. Patient Satisfaction Scale

    Time frame: 6 weeks to 2 years post surgical follow-up

  7. Post-operative complication rates

    Time frame: 6 weeks to 2 years post surgical follow-up

  8. Subsequent surgery rates

    Time frame: 6 weeks to 2 years post surgical follow-up

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 27, 2026
Registry last updated
May 27, 2026

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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