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
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.
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.
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 →Western University, Canada is the lead sponsor of 224 studies on the registry; 56 are open to participants now.
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-Cam or pincer morphology who have failed a trial of conservative treatment
Exclusion:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard arthroscopic osteochondroplasty and concomitant labral repair, using a minimum of two suture anchors.
Procedure: Labral Repair
Standard arthroscopic osteochondroplasty and subsequent labral reconstruction with allograft.
Procedure: Labral Reconstruction
Standard arthroscopic osteochondroplasty and concomitant labral repair, using a minimum of two suture anchors.
Standard arthroscopic osteochondroplasty and subsequent labral reconstruction with allograft.
International Hip Outcome Tool (iHOT) - 12
Time frame: Baseline to 2 years post surgical follow-up
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
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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