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

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 Overview

• Status: Completed
• Conditions: Hip Pain Chronic; Greater Trochanteric Pain Syndrome
• Intervention / Treatment: Device: Topaz; Procedure: Iliotibial band release and trochanteric bursectomy

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Richmond, Victoria, Australia, 3121
      • Epworth Private Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Standard of Care
Experimental: Group 1	Device: Topaz; Radiofrequency micro debridement with Topaz will be used to treat the gluteal tendons following standard of care procedure; Other Names: Topaz AC-4045-01

What is the study measuring?

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
Adverse events		1 year
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

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Principal Investigator: John O'Donnell, M.B., B.S.

Publications and helpful links

General Publications

• Blakey CM, O'Donnell J, Klaber I, Singh P, Arora M, Takla A, Fitzpatrick J. Radiofrequency Microdebridement as an Adjunct to Arthroscopic Surgical Treatment for Recalcitrant Gluteal Tendinopathy: A Double-Blind, Randomized Controlled Trial. Orthop J Sports Med. 2020 Jan 24;8(1):2325967119895602. doi: 10.1177/2325967119895602. eCollection 2020 Jan.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: March 22, 2012
• First Submitted That Met QC Criteria: March 22, 2012
• First Posted (Estimate): March 23, 2012

Study Record Updates

• Last Update Posted (Actual): May 25, 2017
• Last Update Submitted That Met QC Criteria: May 23, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Iliotibial Band Release; Trochanteric Bursectomy; Micro debridement
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Joint Diseases; Musculoskeletal Diseases; Syndrome; Bursitis
• Other Study ID Numbers: SM-2012-01