The Arthroscopic Labral Excision or Repair Trial (ALERT)
NCT ID: NCT03257709
Last Updated: 2017-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
96 participants
INTERVENTIONAL
2016-12-31
2019-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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 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
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.
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.
Interventions
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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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Irreparable labral tear
* Previous fracture of femoral neck or acetabulum
* Female patient who is pregnant
* Established osteoarthritis (Kellgren-Lawrence ≥ 2)
* Hip dysplasia
18 Years
75 Years
ALL
No
Sponsors
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Arthritis Research UK
OTHER
The Royal College of Surgeons of England
OTHER
University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Sion Glyn-Jones
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
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Nuffield Orthopaedic Centre, Oxford University Hospitals Trust
Oxford, Oxfordshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRAS 184490
Identifier Type: -
Identifier Source: org_study_id
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