The Arthroscopic Labral Excision or Repair Trial (ALERT) (ALERT)

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 Overview

• Status: Unknown
• Conditions: Acetabular Labrum Tear
• Intervention / Treatment: Procedure: Arthroscopic acetabular labral repair; Procedure: Arthroscopic acetabular labral resection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joanna S Burchall; Phone Number: 01865737694; Email: joanna.burchall@ndorms.ox.ac.uk
• Study Contact Backup: Name: John AJ Broomfield; Phone Number: 01865737694; Email: john.broomfield@ndorms.ox.ac.uk

Study Locations

• United Kingdom
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 7LD
      • Recruiting
      • Nuffield Orthopaedic Centre, Oxford University Hospitals Trust
      • Contact: Joanna Burchall; Phone Number: 01865737694; Email: joanna.burchall@ndorms.px.ac.uk
      • Contact: John Broomfield; Phone Number: 01865737694; Email: john.broomfield@ndorms.ox.ac.uk
      • Principal Investigator: Sion Glyn-Jones

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Procedure: 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).; Other Names: Labral Repair; Labral Reconstruction
Active Comparator: 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.	Procedure: 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 Names: Labral Resection; Labral Debridement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hip Outcome Score	Change in Hip Outcome Score (Activities of Daily Living Subscale) at 6 months post intervention from baseline.	6 Months Post Intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hip Outcome Scores (HOS)	Hip Outcome Score at 12, 18 and 24 months post-operatively.	12, 18 & 24 months post intervention
Physiologic MRI	T2 relaxation time	6 Months Post Intervention
X Ray	Joint space width	6 Months Post Intervention
X Ray	Kellgren-Lawrence score	6 Months Post Intervention
Biomarkers of Osteo Arthritis (OA)	Biomarkers of OA from synovial fluid and serum.	At surgery and 6, 12 & 24 months post intervention.
Clinical Assessment of Function	Clinical assessment of range of motion and impingement tests.	6, 12 & 24 months post intervention.
Health Economics	Assessment of economic burden associated with disease using EQ5D score	6, 12, 18 & 24 months post intervention
Physiologic MRI	T1 Rho	6 Months Post Intervention

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: Arthritis Research UK; The Royal College of Surgeons of England
• Investigators: Principal Investigator: Sion Glyn-Jones, University of Oxford

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: January 4, 2017
• First Submitted That Met QC Criteria: August 18, 2017
• First Posted (Actual): August 22, 2017

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 18, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: IRAS 184490

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No