The Arthroscopic Labral Excision or Repair Trial (ALERT)

Acetabular Labrum Tear Clinical 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03257709
• Other study ID #: IRAS 184490
• Status: Recruiting
• Phase: N/A
• First received: January 4, 2017
• Last updated: August 18, 2017
• Start date: December 2016
• Est. completion date: December 2019

Study information

• Verified date: August 2017
• Source: University of Oxford
• Contact: Joanna S Burchall
• Phone: 01865737694
• Email: joanna.burchall[@]ndorms.ox.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: December 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acetabular Labrum Tear

Intervention

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).
• 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.

Locations

Country	Name	City	State
United Kingdom	Nuffield Orthopaedic Centre, Oxford University Hospitals Trust	Oxford	Oxfordshire

Sponsors (3)

Lead Sponsor	Collaborator
University of Oxford	Arthritis Research UK, The Royal College of Surgeons of England

Country where clinical trial is conducted

United Kingdom, 

Outcome

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