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Femoral Acetabular ImpingementNCT07608237

Labral Repair vs Reconstruction

A study testing Labral Repair and Labral Reconstruction in people with Femoral Acetabular Impingement, run by Western University, Canada at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Femoral Acetabular Impingement
What is being tested?
Labral Repair and Labral Reconstruction
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
1 siteCanada
Study dates
1 Sep 2026to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 11Show fewer
  • Active smoker
  • Major medical illness
  • Unable to speak and understand English
  • Psychiatric illness that precludes informed consent
  • Unwilling to be followed for 2 years

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site
  • Fowler Kennedy Sport Medicine Clinic

    London, Ontario, N6A 3K7

    Ashley Ambrose, 5196612111 ext. 87528, ashley.ambrose@lhsc.on.ca

    Ryan Degen

Other trials in Canada

About this study

Official title: 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, 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.

Being tested
Labral Repair, Labral Reconstruction
Keywords
labral repair, labral reconstruction
Medical subject headings
Femoracetabular Impingement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Labral RepairProcedure or surgery

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

  • Labral ReconstructionProcedure or surgery

    Standard arthroscopic osteochondroplasty and subsequent labral reconstruction with allograft.

Study groups in NCT07608237
Study groupRoleWhat they receive
Labral RepairActive comparatorStandard arthroscopic osteochondroplasty and concomitant labral repair, using a minimum of two suture anchors.
Receives: Procedure: Labral Repair
Labral ReconstructionActive comparatorStandard arthroscopic osteochondroplasty and subsequent labral reconstruction with allograft.
Receives: Procedure: Labral Reconstruction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. International Hip Outcome Tool (iHOT) - 12

    Measured: Baseline to 2 years post surgical follow-up

Secondary outcomes (8)
  1. Hip Outcome Score- Activities of Daily Living (HOS-ADL)

    Measured: Baseline to 2 years post surgical follow-up

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

    Measured: Baseline to 2 years post surgical follow-up

  3. modified Harris Hip Score (mHHS)

    Measured: Baseline to 2 years post surgical follow-up

  4. EQ-5D

    Measured: Baseline to 2 years post surgical follow-up

  5. Cost Diary

    Measured: 6 weeks to 2 years post surgical follow-up

  6. Patient Satisfaction Scale

    Measured: 6 weeks to 2 years post surgical follow-up

  7. Post-operative complication rates

    Measured: 6 weeks to 2 years post surgical follow-up

  8. Subsequent surgery rates

    Measured: 6 weeks to 2 years post surgical follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07608237
Sponsor's protocol ID
127777
Status last verified
May 2026
First submitted
19 May 2026
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Labral Repair and Labral Reconstruction in people with Femoral Acetabular Impingement, run by Western University, Canada at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

International Hip Outcome Tool (iHOT) - 12 (time frame: Baseline to 2 years post surgical follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.

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