Clinical trial NCT03257709: The Arthroscopic Labral Excision or Repair Trial (ALERT)
Official title: The Arthroscopic Labral Excision or Repair Trial (ALERT) - A Randomised Controlled Trial to Determine the Effectiveness of Arthroscopic Hip Labral Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acetabular Labrum Tear
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Arthritis Research UK
name: The Royal College of Surgeons of England
First posted: 2017-08-22
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hip Outcome Score
timeFrame: 6 Months Post Intervention
Secondary outcomes:
measure: Hip Outcome Scores (HOS)
timeFrame: 12, 18 & 24 months post intervention
measure: Physiologic MRI
timeFrame: 6 Months Post Intervention
measure: X Ray
timeFrame: 6 Months Post Intervention
measure: X Ray
timeFrame: 6 Months Post Intervention
measure: Biomarkers of Osteo Arthritis (OA)
timeFrame: At surgery and 6, 12 & 24 months post intervention.
measure: Clinical Assessment of Function
timeFrame: 6, 12 & 24 months post intervention.
measure: Health Economics
timeFrame: 6, 12, 18 & 24 months post intervention
measure: Physiologic MRI
timeFrame: 6 Months Post Intervention
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Nuffield Orthopaedic Centre, Oxford University Hospitals Trust
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Sion Glyn-Jones
role: PRINCIPAL_INVESTIGATOR
References: