Labral Repair vs Reconstruction

ConditionFemoral Acetabular Impingement

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age40+

SponsorWestern University, Canada

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Moderate concomitant OA (Tönnis 2+)

Have had previous hip surgery

Active joint or systemic infection

Significant muscle paralysis

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Labral Repair
Procedure/Surgery
Standard arthroscopic osteochondroplasty and concomitant labral repair, using a minimum of two suture anchors.
Labral Reconstruction
Procedure/Surgery
Standard arthroscopic osteochondroplasty and subsequent labral reconstruction with allograft.

Treatment groups

220 Participants

are divided into 2 treatment groups

Group A: Labral RepairActive comparator 1 intervention

Group B: Labral ReconstructionActive comparator 1 intervention