Research Study to Compare the Addition of Topaz Micro Debridement to the Standard of Care Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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.|