Research Study to Compare the Addition of Topaz Micro Debridement to the Standard of Care Surgery
|ClinicalTrials.gov Identifier: NCT01562366|
Recruitment Status : Completed
First Posted : March 23, 2012
Last Update Posted : May 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Greater Trochanteric Pain Syndrome Hip Pain Chronic||Device: Topaz Procedure: Iliotibial band release and trochanteric bursectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||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|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
|Experimental: Group 1||
Radiofrequency micro debridement with Topaz will be used to treat the gluteal tendons following standard of care procedure
Other Name: Topaz AC-4045-01
|Active Comparator: Group 2||
Procedure: Iliotibial band release and trochanteric bursectomy
Standard of Care: An iliotibial band release and trochanteric bursectomy will be performed.
Other Name: Standard of Care
- Modified Harris Hip Score [ Time Frame: 6 months ]This is a patient questionnaire used to evaluate hip function following surgery.
- The Western Ontario and McMaster Universities Arthritis Index [ Time Frame: 1 year ]This is a patient questionnaire used to evaluate rheumatic symptoms, stiffness, pain and how it affects the ability to function.
- Visual Analogue Scale [ Time Frame: 1 year ]This is a patient questionnaire designed to evaluate pain.
- SF-12 Health Survey [ Time Frame: 1 year ]This is a patient questionnaire measuring health-related quality of life.
- Duration of surgery between two treatment groups [ Time Frame: 1 day ]The total length (time) of surgery will be compared between the two groups.
- Ultrasound findings [ Time Frame: 1 year ]
- Adverse events [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562366
|Epworth Private Hospital|
|Richmond, Victoria, Australia, 3121|
|Principal Investigator:||John O'Donnell, M.B., B.S.|