ClinicalTrials.gg
Not yet recruitingNCT07608237Updated Aug 31, 2026

Labral Repair vs Reconstruction

An interventional study of Labral Repair and Labral Reconstruction in Femoral Acetabular Impingement, sponsored by Western University, Canada. Not yet recruiting at 1 site in Canada. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by Western University, Canada · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
40 Years and older
Sex
All
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Study summary

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, the investigators 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.

Read the detailed description

Femoroacetabular impingement syndrome (FAIS) is an increasingly common cause hip pain. It is known to cause labral pathology and if left untreated, can also contribute to the development of hip osteoarthritis. 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 osteoarthritis.

Mid- to long-term outcomes have shown durable results following hip arthroscopy with significant improvements in patient reported outcome measures (PROMs). Consequently, hip arthroscopy utilization has continued to increase. Several retrospective cohort studies have attempted to identify prognostic variables associated with procedural outcomes. 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 40. 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. As such, there have been proponents of performing a primary labral reconstruction in this patient population, with better associated outcomes. Others have reported equivocal outcomes between repair and reconstruction for this group. As such, there is no consensus on the best treatment strategy to manage these patients.

The results of this pilot study will allow the investigators to determine whether a full-scale study will be feasible. The investigators 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, the investigators 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.

02

Conditions studied

  • Femoral Acetabular Impingement

Keywords

  • labral repair
  • labral reconstruction
03

In context

Femoracetabular Impingement

116 studies on the registry are indexed under Femoracetabular Impingement; 37 are open to participants now.

This study's planned enrollment of 220 is above the median of 73 across 70 interventional studies indexed under Femoracetabular Impingement.

Browse Femoracetabular Impingement studies →

Lead sponsor

Western University, Canada is the lead sponsor of 224 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
  • Unwilling to be followed for 2 years
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
220 participants (estimated)

Study arms

  • Active comparator
    Labral Repair

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

    Procedure: Labral Repair

  • Active comparator
    Labral Reconstruction

    Standard arthroscopic osteochondroplasty and subsequent labral reconstruction with allograft.

    Procedure: Labral Reconstruction

Interventions

  • ProcedureLabral Repair

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

  • ProcedureLabral Reconstruction

    Standard arthroscopic osteochondroplasty and subsequent labral reconstruction with allograft.

06

What researchers measure

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

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Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07608237
Responsible party
Sponsor
First posted
May 27, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 30, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Aug 31, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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