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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01562366

Enrollment

Registered

2012-03-23

Start date

2012-04-30

Completion date

2016-10-31

Last updated

2017-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Greater Trochanteric Pain Syndrome, Hip Pain Chronic

Keywords

Iliotibial Band Release, Trochanteric Bursectomy, Micro debridement

Brief summary

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.

Interventions

DEVICETopaz

Radiofrequency micro debridement with Topaz will be used to treat the gluteal tendons following standard of care procedure

PROCEDUREIliotibial band release and trochanteric bursectomy

Standard of Care: An iliotibial band release and trochanteric bursectomy will be performed.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026