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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03257709
Study type Interventional
Source University of Oxford
Contact Joanna S Burchall
Phone 01865737694
Email joanna.burchall@ndorms.ox.ac.uk
Status Recruiting
Phase N/A
Start date December 2016
Completion date December 2019

See also
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