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

• ClinicalTrials.gov Identifier: NCT01562366
• Recruitment Status: Completed
• First Posted: March 23, 2012
• Last Update Posted: May 25, 2017
• Sponsor: Smith & Nephew, Inc.
• Information provided by (Responsible Party): Smith & Nephew, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Greater Trochanteric Pain Syndrome; Hip Pain Chronic	Device: Topaz; Procedure: Iliotibial band release and trochanteric bursectomy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Health Services Research
• 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
• Study Start Date: April 2012
• Actual Primary Completion Date: October 2016
• Actual Study Completion Date: October 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Modified Harris Hip Score [ Time Frame: 6 months ]
   This is a patient questionnaire used to evaluate hip function following surgery.

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Australia, Victoria

Epworth Private Hospital

Richmond, Victoria, Australia, 3121

Sponsors and Collaborators

Smith & Nephew, Inc.

Investigators

• Principal Investigator: John O'Donnell, M.B., B.S.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Smith & Nephew, Inc.
• ClinicalTrials.gov Identifier: NCT01562366
• Other Study ID Numbers: SM-2012-01
• First Posted: March 23, 2012
• Last Update Posted: May 25, 2017
• Last Verified: May 2017

Keywords provided by Smith & Nephew, Inc.:

Iliotibial Band Release; Trochanteric Bursectomy; Micro debridement

Additional relevant MeSH terms:

Syndrome; Disease; Pathologic Processes