Acetabular Labrum Tear
Conditions
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.
Interventions
PROCEDUREArthroscopic 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).
PROCEDUREArthroscopic 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.
Sponsors
Arthritis Research UK
The Royal College of Surgeons of England
University of Oxford
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Physiologic MRI | 6 Months Post Intervention | T2 relaxation time |
| X Ray | 6 Months Post Intervention | Joint space width |
| Hip Outcome Scores (HOS) | 12, 18 & 24 months post intervention | Hip Outcome Score at 12, 18 and 24 months post-operatively. |
| Clinical Assessment of Function | 6, 12 & 24 months post intervention. | Clinical assessment of range of motion and impingement tests. |
| Health Economics | 6, 12, 18 & 24 months post intervention | Assessment of economic burden associated with disease using EQ5D score |
| Biomarkers of Osteo Arthritis (OA) | At surgery and 6, 12 & 24 months post intervention. | Biomarkers of OA from synovial fluid and serum. |
Countries
United Kingdom
Contacts
Primary ContactJoanna S Burchall
Backup ContactJohn AJ Broomfield
Outcome results
None listed