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.

NCT07608237 | Not Yet Recruiting

• 1 other identifier: 127777
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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, we 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.

Conditions

Femoral Acetabular Impingement

Keywords

labral repair; labral reconstruction

Outcome Measures

Primary Outcomes (1)

• International Hip Outcome Tool (iHOT) - 12

  Baseline to 2 years post surgical follow-up

Secondary Outcomes (8)

• Hip Outcome Score- Activities of Daily Living (HOS-ADL)

  Baseline to 2 years post surgical follow-up

• Hip Outcome Score- Sport Specific Subscale (HOS-SSS)

  Baseline to 2 years post surgical follow-up

• modified Harris Hip Score (mHHS)

  Baseline to 2 years post surgical follow-up

• EQ-5D

  Baseline to 2 years post surgical follow-up

• Cost Diary

  6 weeks to 2 years post surgical follow-up

Study Arms (2)

Labral Repair

ACTIVE COMPARATOR

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

Procedure: Labral Repair

Labral Reconstruction

ACTIVE COMPARATOR

Standard arthroscopic osteochondroplasty and subsequent labral reconstruction with allograft.

Procedure: Labral Reconstruction

Interventions

Labral Repair PROCEDURE

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

Labral Repair

Labral Reconstruction PROCEDURE

Standard arthroscopic osteochondroplasty and subsequent labral reconstruction with allograft.

Labral Reconstruction

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 informed consent
• Unwilling to be followed for 2 years

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

Fowler Kennedy Sport Medicine Clinic

London, Ontario, N6A 3K7, Canada

Location

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 27, 2026

Record last verified: 2026-05

Locations

CA (1)