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

Hip Pain Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01562366
• Other study ID #: SM-2012-01
• Status: Completed
• Phase: N/A
• First received: March 22, 2012
• Last updated: May 23, 2017
• Start date: April 2012
• Est. completion date: October 2016

Study information

• Verified date: May 2017
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Greater Trochanteric Pain Syndrome
• Hip Pain Chronic
• Syndrome

Intervention

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

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

Locations

Country	Name	City	State
Australia	Epworth Private Hospital	Richmond	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Harris Hip Score	This is a patient questionnaire used to evaluate hip function following surgery.	6 months
Secondary	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
Secondary	Visual Analogue Scale	This is a patient questionnaire designed to evaluate pain.	1 year
Secondary	SF-12 Health Survey	This is a patient questionnaire measuring health-related quality of life.	1 year
Secondary	Duration of surgery between two treatment groups	The total length (time) of surgery will be compared between the two groups.	1 day
Secondary	Ultrasound findings		1 year
Secondary	Adverse events		1 year