NCT03257709

The Arthroscopic Labral Excision or Repair Trial (ALERT)

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acetabular Labrum Tear

Interventions

Type	Name	Description
PROCEDURE	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).
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.

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-12-01
• Completion: 2019-12-01
• First posted: 2017-08-22
• Last updated: 2017-08-22

Locations

1 site across 1 country: United Kingdom