Trial for Femoroacetabular Impingement Treatment (FAIT)

December 2, 2013 updated by: University of Oxford

A Randomised Controlled Trial of Surgical Versus Non-surgical Treatment of Femoroacetabular Impingement

Femoroacetabular Impingement (FAI) describes a condition of the hip where additional bone results in the abutment of the femoral neck against the rim of the acetabulum. This gives rise to localised cartilage damage and pain, but also increases the risk of developing osteoarthritis. The purpose of this study is to compare the effectiveness of arthroscopic surgery versus physiotherapy and activity modification for the treatment of this condition.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Oxford, United Kingdom, OX3 7LD
        • Recruiting
        • Nuffield Orthopaedic Centre, Oxford University Hospitals Trust
        • Principal Investigator:
          • Sion Glyn-Jones, MA MBBS FRCS DPhil
      • Reading, United Kingdom, RG1 5AN
        • Recruiting
        • Royal Berkshire Hospital
        • Principal Investigator:
          • Tony Andrade, M.Sc., F.R.C.S. (Tr & Orth)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Symptomatic patients
  • Age 18-60 years
  • Clinical and radiological evidence of FAI
  • Competent to consent

Exclusion Criteria:

  • Prior hip surgery
  • Established osteoarthritis (Kellgren-Lawrence >/= 2)
  • Hip dysplasia (Centre-Edge angle < 20 degrees on radiograph)
  • Completion of physiotherapy programme targeting FAI within past year
  • Co-morbidities that mean surgical intervention is not possible/safe
  • Contraindication to MRI
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conservative treatment
Physiotherapy and activity modification
Other: Physiotherapy and activity modification
Active Comparator: Surgical treatment
Arthroscopic treatment of femoroacetabular impingement
Procedure: Arthroscopic treatment of femoroacetabular impingement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hip Outcome Score
Time Frame: 8 months post randomisation (approximately 6 months post intervention)
Hip Outcome Score is a patient reported outcome measure
8 months post randomisation (approximately 6 months post intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Reported Outcome Measures
Time Frame: Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)
Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)
Morphological and Physiological MRI
Time Frame: Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)
  • Morphological Parameters
  • Measures of Osteoarthritis
Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)
Hip Radiographs
Time Frame: Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)
  • Morphological Parameters
  • Measures of Osteoarthritis
Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)
Serum and Urinary Biomarkers of Osteoarthritis
Time Frame: Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)
Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)
Clinical Examination
Time Frame: Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)
  • Range of Movement
  • Impingement Tests
Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Investigators

  • Principal Investigator: Sion Glyn-Jones, MA MBBS FRCS DPhil, University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

April 1, 2015

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

June 14, 2013

First Submitted That Met QC Criteria

July 1, 2013

First Posted (Estimate)

July 8, 2013

Study Record Updates

Last Update Posted (Estimate)

December 3, 2013

Last Update Submitted That Met QC Criteria

December 2, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAIT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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