The Arthroscopic Labral Excision or Repair Trial (ALERT)

Study Overview
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Brief Summary
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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
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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. Arm 2 Arthroscopic acetabular labral resection 48 patients per arm (total 96 patients) will be selected from outpatient clinics and the operative waiting list (pre-operative assessment clinics) at the Nuffield Orthopaedic Centre, Oxford. The surgeries will be conducted using routine instrumentation in use at the centre. STUDY PROCEDURES Recruitment All patients will undergo surgery in accordance with established practice regardless of their treatment allocation. Arthroscopy will be performed using standard anterior and lateral portals for insertion of instruments. All patients will undergo arthroscopic evaluation of the entire joint. Subsequent procedures will vary according to treatment allocation: Arm 1 - 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). Arm 2 - 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.

Official Title
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The Arthroscopic Labral Excision or Repair Trial (ALERT) - A Randomised Controlled Trial to Determine the Effectiveness of Arthroscopic Hip Labral Surgery

Conditions
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Acetabular Labrum Tear

Intervention / Treatment
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* Procedure: Arthroscopic acetabular labral repair
* Procedure: Arthroscopic acetabular labral resection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arthroscopic acetabular labral repair<br>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). | Procedure: Arthroscopic acetabular labral repair<br>* 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).<br>* Other names: Labral Reconstruction;|
| Active Comparator: Arthroscopic acetabular labral resection<br>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. | Procedure: Arthroscopic acetabular labral resection<br>* 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.<br>* Other names: Labral Debridement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip Outcome Score | Change in Hip Outcome Score (Activities of Daily Living Subscale) at 6 months post intervention from baseline. | 6 Months Post Intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip Outcome Scores (HOS) | Hip Outcome Score at 12, 18 and 24 months post-operatively. | 12, 18 & 24 months post intervention | 
| Physiologic MRI | T2 relaxation time | 6 Months Post Intervention | 
| X Ray | Joint space width | 6 Months Post Intervention | 
| X Ray | Kellgren-Lawrence score | 6 Months Post Intervention | 
| Biomarkers of Osteo Arthritis (OA) | Biomarkers of OA from synovial fluid and serum. | At surgery and 6, 12 & 24 months post intervention. | 
| Clinical Assessment of Function | Clinical assessment of range of motion and impingement tests. | 6, 12 & 24 months post intervention. | 
| Health Economics | Assessment of economic burden associated with disease using EQ5D score | 6, 12, 18 & 24 months post intervention | 
| Physiologic MRI | T1 Rho | 6 Months Post Intervention |