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

Not Applicable

Completed

• Conditions: Greater Trochanteric Pain Syndrome; Hip Pain Chronic
• Interventions: Procedure: Iliotibial band release and trochanteric bursectomy; Device: Topaz

• Registration Number: NCT01562366
• Lead Sponsor: Smith & Nephew, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-03-22
• Study First Posted: 2012-03-23
• Study Start: 2012-04
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-23
• Last Update Posted: 2017-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Iliotibial band release and trochanteric bursectomy	-
Group 1	Topaz	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale	1 year	This is a patient questionnaire designed to evaluate pain.
Ultrasound findings	1 year
SF-12 Health Survey	1 year	This is a patient questionnaire measuring health-related quality of life.
Adverse events	1 year
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.
Duration of surgery between two treatment groups	1 day	The total length (time) of surgery will be compared between the two groups.

Trial Locations

Locations (1)

Epworth Private Hospital; 🇦🇺 Richmond, Victoria, Australia