Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial for Femoroacetabular Impingement Treatment (FAIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01893034
Recruitment Status : Unknown
Verified December 2013 by University of Oxford.
Recruitment status was:  Recruiting
First Posted : July 8, 2013
Last Update Posted : December 3, 2013
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Femoroacetabular Impingement Procedure: Arthroscopic treatment of femoroacetabular impingement Other: Physiotherapy and activity modification Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Surgical Versus Non-surgical Treatment of Femoroacetabular Impingement
Study Start Date : July 2013
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : July 2017

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



Primary Outcome Measures :
  1. Hip Outcome Score [ Time Frame: 8 months post randomisation (approximately 6 months post intervention) ]
    Hip Outcome Score is a patient reported outcome measure


Secondary Outcome Measures :
  1. Patient Reported Outcome Measures [ Time Frame: Regular intervals up to 38 months post randomisation (approximately 3 years post intervention) ]
  2. Morphological and Physiological MRI [ Time Frame: Regular intervals up to 38 months post randomisation (approximately 3 years post intervention) ]
    • Morphological Parameters
    • Measures of Osteoarthritis

  3. Hip Radiographs [ Time Frame: Regular intervals up to 38 months post randomisation (approximately 3 years post intervention) ]
    • Morphological Parameters
    • Measures of Osteoarthritis

  4. Serum and Urinary Biomarkers of Osteoarthritis [ Time Frame: Regular intervals up to 38 months post randomisation (approximately 3 years post intervention) ]
  5. Clinical Examination [ Time Frame: Regular intervals up to 38 months post randomisation (approximately 3 years post intervention) ]
    • Range of Movement
    • Impingement Tests



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893034


Contacts
Layout table for location contacts
Contact: Antony Palmer, MA BMBCh +441865 227374 antony.palmer@ndorms.ox.ac.uk

Locations
Layout table for location information
United Kingdom
Nuffield Orthopaedic Centre, Oxford University Hospitals Trust Recruiting
Oxford, United Kingdom, OX3 7LD
Principal Investigator: Sion Glyn-Jones, MA MBBS FRCS DPhil         
Royal Berkshire Hospital Recruiting
Reading, United Kingdom, RG1 5AN
Principal Investigator: Tony Andrade, M.Sc., F.R.C.S. (Tr & Orth)         
Sponsors and Collaborators
University of Oxford
Investigators
Layout table for investigator information
Principal Investigator: Sion Glyn-Jones, MA MBBS FRCS DPhil University of Oxford

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01893034     History of Changes
Other Study ID Numbers: FAIT
First Posted: July 8, 2013    Key Record Dates
Last Update Posted: December 3, 2013
Last Verified: December 2013

Keywords provided by University of Oxford:
Femoroacetabular Impingement
Arthroscopy
Physiotherapy
Randomised Controlled Trial

Additional relevant MeSH terms:
Layout table for MeSH terms
Femoracetabular Impingement
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes