NCT03257709

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2017

Completed
8 months until next milestone

First Posted

Study publicly available on registry

August 22, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

January 4, 2017

Last Update Submit

August 18, 2017

Conditions

Acetabular Labrum Tear

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Hip Outcome Scores (HOS)

    12, 18 & 24 months post intervention

  • Physiologic MRI

    6 Months Post Intervention

  • X Ray

    6 Months Post Intervention

  • X Ray

    6 Months Post Intervention

  • Biomarkers of Osteo Arthritis (OA)

    At surgery and 6, 12 & 24 months post intervention.

  • +3 more secondary outcomes

Study Arms (2)

Arthroscopic acetabular labral repair

ACTIVE COMPARATOR

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

Arthroscopic acetabular labral resection

ACTIVE COMPARATOR

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

Interventions

Arthroscopic acetabular labral repairPROCEDURE

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).

Also known as: Labral Repair, Labral Reconstruction
Arthroscopic acetabular labral repair
Arthroscopic acetabular labral resectionPROCEDURE

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.

Also known as: Labral Resection, Labral Debridement
Arthroscopic acetabular labral resection

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nuffield Orthopaedic Centre, Oxford University Hospitals Trust

Oxford, Oxfordshire, OX3 7LD, United Kingdom

RECRUITING

Study Officials

  • Sion Glyn-Jones

    University of Oxford

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanna S Burchall

CONTACT

01865737694joanna.burchall@ndorms.ox.ac.uk

John AJ Broomfield

CONTACT

01865737694john.broomfield@ndorms.ox.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2017

First Posted

August 22, 2017

Study Start

December 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2019

Last Updated

August 22, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)