Femoroacetabular ImpingementFAITNCT01893034
Trial for Femoroacetabular Impingement Treatment
A study testing Arthroscopic treatment of femoroacetabular impingement and Physiotherapy and activity modification in people with Femoroacetabular Impingement, run by University of Oxford at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Femoroacetabular Impingement
- What is being tested?
- Arthroscopic treatment of femoroacetabular impingement and Physiotherapy and activity modification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jul 2013to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Symptomatic patients
- Age 18-60 years
- Clinical and radiological evidence of FAI
- Competent to consent
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Nuffield Orthopaedic Centre, Oxford University Hospitals Trust
Oxford, OX3 7LD
Sion Glyn-Jones, MA MBBS FRCS DPhil
- Recruiting
Royal Berkshire Hospital
Reading, RG1 5AN
Tony Andrade, M.Sc., F.R.C.S. (Tr & Orth)
About this study
Official title: 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.
- Conditions
- Femoroacetabular Impingement
- Being tested
- Arthroscopic treatment of femoroacetabular impingement, Physiotherapy and activity modification
- Keywords
- Femoroacetabular Impingement, Arthroscopy, Physiotherapy, Randomised Controlled Trial
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic treatment of femoroacetabular impingementProcedure or surgery
Physiotherapy and activity modificationOther
| Study group | Role | What they receive |
|---|---|---|
| Conservative treatment | Active comparator | Physiotherapy and activity modification Receives: Other: Physiotherapy and activity modification |
| Surgical treatment | Active comparator | Arthroscopic treatment of femoroacetabular impingement Receives: Procedure: Arthroscopic treatment of femoroacetabular impingement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip Outcome Score
Hip Outcome Score is a patient reported outcome measure
Measured: 8 months post randomisation (approximately 6 months post intervention)
Secondary outcomes (5)
Patient Reported Outcome Measures
Measured: Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)
Morphological and Physiological MRI
- Morphological Parameters
- Measures of Osteoarthritis
Measured: Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)
Hip Radiographs
- Morphological Parameters
- Measures of Osteoarthritis
Measured: Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)
Serum and Urinary Biomarkers of Osteoarthritis
Measured: Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)
Clinical Examination
- Range of Movement
- Impingement Tests
Measured: Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionApr 2015 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Femoroacetabular ImpingementStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sion Glyn-Jones, MA MBBS FRCS DPhil, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893034
- Sponsor's protocol ID
- FAIT
- Acronym
- FAIT
- Status last verified
- Dec 2013
- First submitted
- 14 Jun 2013
- Last updated
- 3 Dec 2013
- Results posted
- No
Publications
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.
PubMed 39592214Palmer 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.
PubMed 30733197Palmer 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.
PubMed 25431439
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Surgical Versus Non-surgical Treatment of Femoroacetabular Impingement
- ClinicalTrials.gov ID
- NCT01893034
- Acronym / sponsor ID
- FAIT / FAIT
- Conditions
- Femoroacetabular Impingement
- Keywords
- Femoroacetabular Impingement, Arthroscopy, Physiotherapy, Randomised Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 8 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative treatment | Active comparator | Other: Physiotherapy and activity modificationPhysiotherapy and activity modification |
| Surgical treatment | Active comparator | Procedure: Arthroscopic treatment of femoroacetabular impingementArthroscopic treatment of femoroacetabular impingement |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Symptomatic patients
- Age 18-60 years
- Clinical and radiological evidence of FAI
- Competent to consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic treatment of femoroacetabular impingement | Procedure or surgery | Surgical treatment |
| Physiotherapy and activity modification | Other | Conservative treatment |
Primary outcome
Hip Outcome Score
Time frame: 8 months post randomisation (approximately 6 months post intervention)
Hip Outcome Score is a patient reported outcome measure
5 secondary outcomes
Patient Reported Outcome Measures
Time frame: 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)
Hip Radiographs
Time frame: 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)
Clinical Examination
Time frame: Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2013.
- Derived from this study: PubMed 39592214Palmer 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.
- Derived from this study: PubMed 30733197Palmer 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.
- Derived from this study: PubMed 25431439Palmer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sion Glyn-Jones, MA MBBS FRCS DPhil principal investigator
University of Oxford
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic treatment of femoroacetabular impingement and Physiotherapy and activity modification in people with Femoroacetabular Impingement, run by University of Oxford at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antony Palmer, MA BMBCh (+441865 227374, antony.palmer@ndorms.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hip Outcome Score (time frame: 8 months post randomisation (approximately 6 months post intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01893034, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2013.