Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-01-24 @ 8:16 PM
Study NCT ID:
NCT01562366
Status:
COMPLETED
Last Update Posted:
2017-05-25
First Post:
2012-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research Study to Compare the Addition of Topaz Micro Debridement to the Standard of Care Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-23', 'studyFirstSubmitDate': '2012-03-22', 'studyFirstSubmitQcDate': '2012-03-22', 'lastUpdatePostDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Harris Hip Score', 'timeFrame': '6 months', 'description': 'This is a patient questionnaire used to evaluate hip function following surgery.'}], 'secondaryOutcomes': [{'measure': 'The Western Ontario and McMaster Universities Arthritis Index', 'timeFrame': '1 year', 'description': 'This is a patient questionnaire used to evaluate rheumatic symptoms, stiffness, pain and how it affects the ability to function.'}, {'measure': 'Visual Analogue Scale', 'timeFrame': '1 year', 'description': 'This is a patient questionnaire designed to evaluate pain.'}, {'measure': 'SF-12 Health Survey', 'timeFrame': '1 year', 'description': 'This is a patient questionnaire measuring health-related quality of life.'}, {'measure': 'Duration of surgery between two treatment groups', 'timeFrame': '1 day', 'description': 'The total length (time) of surgery will be compared between the two groups.'}, {'measure': 'Ultrasound findings', 'timeFrame': '1 year'}, {'measure': 'Adverse events', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Iliotibial Band Release', 'Trochanteric Bursectomy', 'Micro debridement'], 'conditions': ['Greater Trochanteric Pain Syndrome', 'Hip Pain Chronic']}, 'referencesModule': {'references': [{'pmid': '32047828', 'type': 'DERIVED', 'citation': "Blakey CM, O'Donnell J, Klaber I, Singh P, Arora M, Takla A, Fitzpatrick J. Radiofrequency Microdebridement as an Adjunct to Arthroscopic Surgical Treatment for Recalcitrant Gluteal Tendinopathy: A Double-Blind, Randomized Controlled Trial. Orthop J Sports Med. 2020 Jan 24;8(1):2325967119895602. doi: 10.1177/2325967119895602. eCollection 2020 Jan."}]}, 'descriptionModule': {'briefSummary': 'Compare the surgical use of Topaz with the Standard Of Care in the treatment of Greater Trochanteric Pain Syndrome (a type of hip pain). The hypothesis is that there is a difference between the two treatment groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female or male aged between 40-70 years old, females and males are eligible\n2. A history of \\> 6 months of conservative care treatment for lateral hip pain, including but not limited to local anaesthetic and steroid injections into the trochanteric bursa\n3. Pre-operative MRI and ultrasound with evidence of GTPS within the previous 24 weeks\n4. Willing to comply with the protocol and follow-up visits\n5. Signed the Independent Ethics Committee (IEC) approved Informed Consent Form\n\nExclusion Criteria:\n\n1. Previous surgery to the hip such as hip replacement, fracture neck of femur fixation, or repair of gluteal tendons\n2. Subjects with sero-positive or sero-negative arthropathy\n3. Long term steroid use \\> 6 weeks\n4. Allergy to drugs to be used in the procedure\n5. Medical co-morbidities that preclude surgical intervention\n6. Inability to understand or respond to the study questionnaires\n7. Females who are pregnant, or pregnancy is suspected or planned within the clinical investigation timeframe\n8. Subjects who are simultaneously participating in another device or pharmaceutical investigation\n\nIntra-operative Exclusion:\n\n1. Abductor tears\n2. Severe tendinopathy'}, 'identificationModule': {'nctId': 'NCT01562366', 'briefTitle': 'Research Study to Compare the Addition of Topaz Micro Debridement to the Standard of Care Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Smith & Nephew, Inc.'}, 'officialTitle': 'A Randomised, Controlled, Double-blind Clinical Investigation on the Efficacy and Safety of Radiofrequency Micro Debridement, Topaz, in Recalcitrant Greater Trochanteric Pain Syndrome (GTPS) vs. Standard of Care', 'orgStudyIdInfo': {'id': 'SM-2012-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'interventionNames': ['Device: Topaz']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'interventionNames': ['Procedure: Iliotibial band release and trochanteric bursectomy']}], 'interventions': [{'name': 'Topaz', 'type': 'DEVICE', 'otherNames': ['Topaz AC-4045-01'], 'description': 'Radiofrequency micro debridement with Topaz will be used to treat the gluteal tendons following standard of care procedure', 'armGroupLabels': ['Group 1']}, {'name': 'Iliotibial band release and trochanteric bursectomy', 'type': 'PROCEDURE', 'otherNames': ['Standard of Care'], 'description': 'Standard of Care: An iliotibial band release and trochanteric bursectomy will be performed.', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3121', 'city': 'Richmond', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Epworth Private Hospital', 'geoPoint': {'lat': -37.81819, 'lon': 145.00176}}], 'overallOfficials': [{'name': "John O'Donnell, M.B., B.S.", 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Smith & Nephew, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}