Research Study to Compare the Addition of Topaz Micro Debridement to the Standard of Care Surgery

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Greater Trochanteric Pain Syndrome, Hip Pain Chronic

Intervention / Treatment
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* Device: Topaz
* Procedure: Iliotibial band release and trochanteric bursectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female or male aged between 40-70 years old, females and males are eligible 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 Pre-operative MRI and ultrasound with evidence of GTPS within the previous 24 weeks Willing to comply with the protocol and follow-up visits Signed the Independent Ethics Committee (IEC) approved Informed Consent Form Exclusion Criteria: Previous surgery to the hip such as hip replacement, fracture neck of femur fixation, or repair of gluteal tendons Subjects with sero-positive or sero-negative arthropathy Long term steroid use > 6 weeks Allergy to drugs to be used in the procedure Medical co-morbidities that preclude surgical intervention Inability to understand or respond to the study questionnaires Females who are pregnant, or pregnancy is suspected or planned within the clinical investigation timeframe Subjects who are simultaneously participating in another device or pharmaceutical investigation Intra-operative Exclusion: Abductor tears Severe tendinopathy

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br> | Device: Topaz<br>* Radiofrequency micro debridement with Topaz will be used to treat the gluteal tendons following standard of care procedure<br>* Other names: Topaz AC-4045-01;|
| Active Comparator: Group 2<br> | Procedure: Iliotibial band release and trochanteric bursectomy<br>* Standard of Care: An iliotibial band release and trochanteric bursectomy will be performed.<br>* Other names: Standard of Care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Harris Hip Score | This is a patient questionnaire used to evaluate hip function following surgery. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Western Ontario and McMaster Universities Arthritis Index | This is a patient questionnaire used to evaluate rheumatic symptoms, stiffness, pain and how it affects the ability to function. | 1 year | 
| Visual Analogue Scale | This is a patient questionnaire designed to evaluate pain. | 1 year | 
| SF-12 Health Survey | This is a patient questionnaire measuring health-related quality of life. | 1 year | 
| Duration of surgery between two treatment groups | The total length (time) of surgery will be compared between the two groups. | 1 day | 
| Ultrasound findings |  | 1 year | 
| Adverse events |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iliotibial Band Release, Trochanteric Bursectomy, Micro debridement