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Trial for Femoroacetabular Impingement Treatment (FAIT)

Primary Purpose

Femoroacetabular Impingement

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Arthroscopic treatment of femoroacetabular impingement
Physiotherapy and activity modification
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoroacetabular Impingement focused on measuring Femoroacetabular Impingement, Arthroscopy, Physiotherapy, Randomised Controlled Trial

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nuffield Orthopaedic Centre, Oxford University Hospitals TrustRecruiting
  • Royal Berkshire HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Conservative treatment

Surgical treatment

Arm Description

Physiotherapy and activity modification

Arthroscopic treatment of femoroacetabular impingement

Outcomes

Primary Outcome Measures

Hip Outcome Score
Hip Outcome Score is a patient reported outcome measure

Secondary Outcome Measures

Patient Reported Outcome Measures
Morphological and Physiological MRI
Morphological Parameters Measures of Osteoarthritis
Hip Radiographs
Morphological Parameters Measures of Osteoarthritis
Serum and Urinary Biomarkers of Osteoarthritis
Clinical Examination
Range of Movement Impingement Tests

Full Information

First Posted
June 14, 2013
Last Updated
December 2, 2013
Sponsor
University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT01893034
Brief Title
Trial for Femoroacetabular Impingement Treatment
Acronym
FAIT
Official Title
A Randomised Controlled Trial of Surgical Versus Non-surgical Treatment of Femoroacetabular Impingement
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoroacetabular Impingement
Keywords
Femoroacetabular Impingement, Arthroscopy, Physiotherapy, Randomised Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conservative treatment
Arm Type
Active Comparator
Arm Description
Physiotherapy and activity modification
Arm Title
Surgical treatment
Arm Type
Active Comparator
Arm Description
Arthroscopic treatment of femoroacetabular impingement
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic treatment of femoroacetabular impingement
Intervention Type
Other
Intervention Name(s)
Physiotherapy and activity modification
Primary Outcome Measure Information:
Title
Hip Outcome Score
Description
Hip Outcome Score is a patient reported outcome measure
Time Frame
8 months post randomisation (approximately 6 months post intervention)
Secondary Outcome Measure Information:
Title
Patient Reported Outcome Measures
Time Frame
Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)
Title
Morphological and Physiological MRI
Description
Morphological Parameters Measures of Osteoarthritis
Time Frame
Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)
Title
Hip Radiographs
Description
Morphological Parameters Measures of Osteoarthritis
Time Frame
Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)
Title
Serum and Urinary Biomarkers of Osteoarthritis
Time Frame
Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)
Title
Clinical Examination
Description
Range of Movement Impingement Tests
Time Frame
Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antony Palmer, MA BMBCh
Phone
+441865 227374
Email
antony.palmer@ndorms.ox.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sion Glyn-Jones, MA MBBS FRCS DPhil
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nuffield Orthopaedic Centre, Oxford University Hospitals Trust
City
Oxford
ZIP/Postal Code
OX3 7LD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sion Glyn-Jones, MA MBBS FRCS DPhil
Facility Name
Royal Berkshire Hospital
City
Reading
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tony Andrade, M.Sc., F.R.C.S. (Tr & Orth)

12. IPD Sharing Statement

Citations:
PubMed Identifier
30733197
Citation
Palmer AJR, Ayyar Gupta V, Fernquest S, Rombach I, Dutton SJ, Mansour R, Wood S, Khanduja V, Pollard TCB, McCaskie AW, Barker KL, Andrade TJMD, Carr AJ, Beard DJ, Glyn-Jones S; FAIT Study Group. Arthroscopic hip surgery compared with physiotherapy and activity modification for the treatment of symptomatic femoroacetabular impingement: multicentre randomised controlled trial. BMJ. 2019 Feb 7;364:l185. doi: 10.1136/bmj.l185. Erratum In: BMJ. 2021 Jan 18;372:m3715.
Results Reference
derived
PubMed Identifier
25431439
Citation
Palmer AJ, Ayyar-Gupta V, Dutton SJ, Rombach I, Cooper CD, Pollard TC, Hollinghurst D, Taylor A, Barker KL, McNally EG, Beard DJ, Andrade AJ, Carr AJ, Glyn-Jones S. Protocol for the Femoroacetabular Impingement Trial (FAIT): a multi-centre randomised controlled trial comparing surgical and non-surgical management of femoroacetabular impingement. Bone Joint Res. 2014 Nov;3(11):321-7. doi: 10.1302/2046-3758.311.2000336.
Results Reference
derived

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Trial for Femoroacetabular Impingement Treatment

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