NCT01893034

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.

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
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

June 14, 2013

Completed
17 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

December 3, 2013

Status Verified

December 1, 2013

Enrollment Period

1.8 years

First QC Date

June 14, 2013

Last Update Submit

December 2, 2013

Conditions

Keywords

Femoroacetabular ImpingementArthroscopyPhysiotherapyRandomised Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Hip Outcome Score

    Hip Outcome Score is a patient reported outcome measure

    8 months post randomisation (approximately 6 months post intervention)

Secondary Outcomes (5)

  • Patient Reported Outcome Measures

    Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)

  • Morphological and Physiological MRI

    Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)

  • Hip Radiographs

    Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)

  • Serum and Urinary Biomarkers of Osteoarthritis

    Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)

  • Clinical Examination

    Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)

Study Arms (2)

Conservative treatment

ACTIVE COMPARATOR

Physiotherapy and activity modification

Other: Physiotherapy and activity modification

Surgical treatment

ACTIVE COMPARATOR

Arthroscopic treatment of femoroacetabular impingement

Procedure: Arthroscopic treatment of femoroacetabular impingement

Interventions

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nuffield Orthopaedic Centre, Oxford University Hospitals Trust

Oxford, OX3 7LD, United Kingdom

RECRUITING

Royal Berkshire Hospital

Reading, RG1 5AN, United Kingdom

RECRUITING

Related Publications (3)

  • Palmer A, Fernquest S, Rombach I, Harin A, Mansour R, Dutton S, Dijkstra HP, Andrade T, Glyn-Jones S; FAIT Study Group. Medium-term results of arthroscopic hip surgery compared with physiotherapy and activity modification for the treatment of femoroacetabular impingement syndrome: a multi-centre randomised controlled trial. Br J Sports Med. 2025 Jan 2;59(2):109-117. doi: 10.1136/bjsports-2023-107712.

  • 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.

  • 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.

MeSH Terms

Conditions

Femoracetabular Impingement

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Sion Glyn-Jones, MA MBBS FRCS DPhil

    University of Oxford

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antony Palmer, MA BMBCh

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2013

First Posted

July 8, 2013

Study Start

July 1, 2013

Primary Completion

April 1, 2015

Study Completion

July 1, 2017

Last Updated

December 3, 2013

Record last verified: 2013-12

Locations