Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-04 @ 6:00 AM
Study NCT ID:
NCT01893034
Status:
UNKNOWN
Last Update Posted:
2013-12-03
First Post:
2013-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial for Femoroacetabular Impingement Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057925', 'term': 'Femoracetabular Impingement'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-12-02', 'studyFirstSubmitDate': '2013-06-14', 'studyFirstSubmitQcDate': '2013-07-01', 'lastUpdatePostDateStruct': {'date': '2013-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hip Outcome Score', 'timeFrame': '8 months post randomisation (approximately 6 months post intervention)', 'description': 'Hip Outcome Score is a patient reported outcome measure'}], 'secondaryOutcomes': [{'measure': 'Patient Reported Outcome Measures', 'timeFrame': 'Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)'}, {'measure': 'Morphological and Physiological MRI', 'timeFrame': 'Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)', 'description': '* Morphological Parameters\n* Measures of Osteoarthritis'}, {'measure': 'Hip Radiographs', 'timeFrame': 'Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)', 'description': '* Morphological Parameters\n* Measures of Osteoarthritis'}, {'measure': 'Serum and Urinary Biomarkers of Osteoarthritis', 'timeFrame': 'Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)'}, {'measure': 'Clinical Examination', 'timeFrame': 'Regular intervals up to 38 months post randomisation (approximately 3 years post intervention)', 'description': '* Range of Movement\n* Impingement Tests'}]}, 'conditionsModule': {'keywords': ['Femoroacetabular Impingement', 'Arthroscopy', 'Physiotherapy', 'Randomised Controlled Trial'], 'conditions': ['Femoroacetabular Impingement']}, 'referencesModule': {'references': [{'pmid': '39592214', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '30733197', 'type': 'DERIVED', '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.'}, {'pmid': '25431439', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic patients\n* Age 18-60 years\n* Clinical and radiological evidence of FAI\n* Competent to consent\n\nExclusion Criteria:\n\n* Prior hip surgery\n* Established osteoarthritis (Kellgren-Lawrence \\>/= 2)\n* Hip dysplasia (Centre-Edge angle \\< 20 degrees on radiograph)\n* Completion of physiotherapy programme targeting FAI within past year\n* Co-morbidities that mean surgical intervention is not possible/safe\n* Contraindication to MRI\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01893034', 'acronym': 'FAIT', 'briefTitle': 'Trial for Femoroacetabular Impingement Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'A Randomised Controlled Trial of Surgical Versus Non-surgical Treatment of Femoroacetabular Impingement', 'orgStudyIdInfo': {'id': 'FAIT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conservative treatment', 'description': 'Physiotherapy and activity modification', 'interventionNames': ['Other: Physiotherapy and activity modification']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surgical treatment', 'description': 'Arthroscopic treatment of femoroacetabular impingement', 'interventionNames': ['Procedure: Arthroscopic treatment of femoroacetabular impingement']}], 'interventions': [{'name': 'Arthroscopic treatment of femoroacetabular impingement', 'type': 'PROCEDURE', 'armGroupLabels': ['Surgical treatment']}, {'name': 'Physiotherapy and activity modification', 'type': 'OTHER', 'armGroupLabels': ['Conservative treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 7LD', 'city': 'Oxford', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Sion Glyn-Jones, MA MBBS FRCS DPhil', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nuffield Orthopaedic Centre, Oxford University Hospitals Trust', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'RG1 5AN', 'city': 'Reading', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Tony Andrade, M.Sc., F.R.C.S. (Tr & Orth)', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Berkshire Hospital', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}], 'centralContacts': [{'name': 'Antony Palmer, MA BMBCh', 'role': 'CONTACT', 'email': 'antony.palmer@ndorms.ox.ac.uk', 'phone': '+441865 227374'}], 'overallOfficials': [{'name': 'Sion Glyn-Jones, MA MBBS FRCS DPhil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oxford'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}