Research Study to Compare the Addition of Topaz Micro Debridement to the Standard of Care Surgery
CompletedNot applicableNCT01562366
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Greater Trochanteric Pain Syndrome
- Hip Pain Chronic
- Interventions
- Device: Topaz
- Procedure: Iliotibial band release and trochanteric bursectomy
- Sponsor
- Smith & Nephew, Inc.
- Start date
- 2012-04
- Primary completion
- 2016-10
- Sex
- All
- Age range
- from 40 Years to 70 Years
- Results posted
- No results posted in this snapshot
- Countries
- Australia
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Female or male aged between 40-70 years old, females and males are eligible 2. 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 3. Pre-operative MRI and ultrasound with evidence of GTPS within the previous 24 weeks 4. Willing to comply with the protocol and follow-up visits 5. Signed the Independent Ethics Committee (IEC) approved Informed Consent Form Exclusion Criteria: 1. Previous surgery to the hip such as hip replacement, fracture neck of femur fixation, or repair of gluteal tendons 2. Subjects with sero-positive or sero-negative arthropathy 3. Long term steroid use \> 6 weeks 4. Allergy to drugs to be used in the procedure 5. Medical co-morbidities that preclude surgical intervention 6. Inability to understand or respond to the study questionnaires 7. Females who are pregnant, or pregnancy is suspected or planned within the clinical investigation timeframe 8. Subjects who are simultaneously participating in another device or pharmaceutical investigation Intra-operative Exclusion: 1. Abductor tears 2. Severe tendinopathy
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01562366