Acetabular Labrum Tear Clinical Trial
Official title:
The Arthroscopic Labral Excision or Repair Trial (ALERT) - A Randomised Controlled Trial to Determine the Effectiveness of Arthroscopic Hip Labral Surgery
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.
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.
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