The Arthroscopic Labral Excision or Repair Trial (ALERT) - A Randomised Controlled Trial to Determine the Effectiveness of Arthroscopic Hip Labral Surgery
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Oxford
- Enrollment
- 96
- Locations
- 2
- Primary Endpoint
- Hip Outcome Score
Study Overview
Brief Summary
This study compares two established surgical treatments for acetabular labral tears. Patients will be prospectively recruited and randomised to either labral repair or debridement. All patients will be followed for 2 years after intervention with a primary outcome assessment at 6 months.
Detailed Description
STUDY DESIGN
Study design This will be a two-arm randomised controlled parallel group superiority study and will take place in a hospital setting. Stratification will be performed for sex and age by means of a minimisation technique during randomisation for each subject entering the trial.
Study population:
Adults between 18 and 75 years of age diagnosed with symptomatic acetabular labral tears demonstrated on MRI arthrogram but without radiographic evidence of OA ie: Kellgren & Lawrence grade less than 2 randomly selected from the Nuffield Orthopaedic Centre outpatient clinics.
Arm 1 Arthroscopic acetabular labral repair.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Willing and able to give informed consent for participation in the study.
- •Male or Female, aged between 18 and 75 years.
- •Symptomatic labral tear with evidence of labral tear on MRI.
- •No radiographic evidence of OA (Kellgren-Lawrence Grade < 2)
Exclusion Criteria
- •Previous ipsilateral hip surgery
- •Irreparable labral tear
- •Previous fracture of femoral neck or acetabulum
- •Female patient who is pregnant
- •Established osteoarthritis (Kellgren-Lawrence ≥ 2)
- •Hip dysplasia
Arms & Interventions
Arthroscopic acetabular labral repair
Acetabular labral tear will be identified and reattached using suture anchors until a stable repair is achieved. If evidence of FAI is present ie: a cam or pincer lesion is identified then this will be treated with osteochondroplasty (cam) or acetabular rim recession (pincer).
Intervention: Arthroscopic acetabular labral repair (Procedure)
Arthroscopic acetabular labral resection
The acetabular labral tear will be identified and its' limits defined. The torn portion of labrum will be resected to a stable edge. As with arm 1 there will be treatment of FAI if identified.
Intervention: Arthroscopic acetabular labral resection (Procedure)
Outcomes
Primary Outcomes
Hip Outcome Score
Time Frame: 6 Months Post Intervention
Change in Hip Outcome Score (Activities of Daily Living Subscale) at 6 months post intervention from baseline.
Secondary Outcomes
- Health Economics(6, 12, 18 & 24 months post intervention)
- X Ray(6 Months Post Intervention)
- Biomarkers of Osteo Arthritis (OA)(At surgery and 6, 12 & 24 months post intervention.)
- Hip Outcome Scores (HOS)(12, 18 & 24 months post intervention)
- Clinical Assessment of Function(6, 12 & 24 months post intervention.)
- Physiologic MRI(6 Months Post Intervention)