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.
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
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.
- Conditions
- Femoral Acetabular Impingement
- 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 group | Role | What they receive |
|---|---|---|
| Labral Repair | Active comparator | Standard arthroscopic osteochondroplasty and concomitant labral repair, using a minimum of two suture anchors. Receives: Procedure: Labral Repair |
| Labral Reconstruction | Active comparator | Standard 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.
International Hip Outcome Tool (iHOT) - 12
Measured: Baseline to 2 years post surgical follow-up
Secondary outcomes (8)
Hip Outcome Score- Activities of Daily Living (HOS-ADL)
Measured: Baseline to 2 years post surgical follow-up
Hip Outcome Score- Sport Specific Subscale (HOS-SSS)
Measured: Baseline to 2 years post surgical follow-up
modified Harris Hip Score (mHHS)
Measured: Baseline to 2 years post surgical follow-up
EQ-5D
Measured: Baseline to 2 years post surgical follow-up
Cost Diary
Measured: 6 weeks to 2 years post surgical follow-up
Patient Satisfaction Scale
Measured: 6 weeks to 2 years post surgical follow-up
Post-operative complication rates
Measured: 6 weeks to 2 years post surgical follow-up
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.
- First posted27 May 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Acetabular ImpingementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Labral Repair Versus Reconstruction in Symptomatic Femoroacetabular Impingement in Patients Over 40 Years of Age - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07608237
- Acronym / sponsor ID
- 127777
- Conditions
- Femoral Acetabular Impingement
- Keywords
- labral repair, labral reconstruction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Labral Repair | Active comparator | Procedure: Labral RepairStandard arthroscopic osteochondroplasty and concomitant labral repair, using a minimum of two suture anchors. |
| Labral Reconstruction | Active comparator | Procedure: Labral ReconstructionStandard arthroscopic osteochondroplasty and subsequent labral reconstruction with allograft. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Cam or pincer morphology who have failed a trial of conservative treatment
Key exclusion criteria (11 listed)
- Moderate concomitant OA (Tönnis 2+)
- Have had previous hip surgery
- Active joint or systemic infection
- Significant muscle paralysis
- Inflammatory arthropathies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Labral RepairStandard arthroscopic osteochondroplasty and concomitant labral repair, using a minimum of two suture anchors. | Procedure or surgery | Labral Repair |
| Labral ReconstructionStandard arthroscopic osteochondroplasty and subsequent labral reconstruction with allograft. | Procedure or surgery | Labral Reconstruction |
Primary outcome
International Hip Outcome Tool (iHOT) - 12
Time frame: Baseline to 2 years post surgical follow-up
8 secondary outcomes
Hip Outcome Score- Activities of Daily Living (HOS-ADL)
Time frame: Baseline to 2 years post surgical follow-up
Hip Outcome Score- Sport Specific Subscale (HOS-SSS)
Time frame: Baseline to 2 years post surgical follow-up
modified Harris Hip Score (mHHS)
Time frame: Baseline to 2 years post surgical follow-up
EQ-5D
Time frame: Baseline to 2 years post surgical follow-up
Cost Diary
Time frame: 6 weeks to 2 years post surgical follow-up
Patient Satisfaction Scale
Time frame: 6 weeks to 2 years post surgical follow-up
Post-operative complication rates
Time frame: 6 weeks to 2 years post surgical follow-up
Subsequent surgery rates
Time frame: 6 weeks to 2 years post surgical follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.