The Arthroscopic Labral Excision or Repair Trial (ALERT)

Not Applicable

• Conditions: Acetabular Labrum Tear
• Interventions: Procedure: Arthroscopic acetabular labral repair; Procedure: Arthroscopic acetabular labral resection

• Registration Number: NCT03257709
• Lead Sponsor: University of Oxford

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-01-04
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-18
• Last Update Submitted: 2017-08-18
• Study First Posted: 2017-08-22
• Last Update Posted: 2017-08-22
• Primary Completion: 2017-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arthroscopic acetabular labral repair	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).
Arthroscopic acetabular labral resection	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.

Primary Outcome Measures

Name	Time	Method
Hip Outcome Score	6 Months Post Intervention	Change in Hip Outcome Score (Activities of Daily Living Subscale) at 6 months post intervention from baseline.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nuffield Orthopaedic Centre, Oxford University Hospitals Trust; 🇬🇧 Oxford, Oxfordshire, United Kingdom