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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01562366
Recruitment Status : Completed
First Posted : March 23, 2012
Last Update Posted : May 25, 2017
Information provided by (Responsible Party):
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.

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

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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

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

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01562366

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Australia, Victoria
Epworth Private Hospital
Richmond, Victoria, Australia, 3121
Sponsors and Collaborators
Smith & Nephew, Inc.
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Principal Investigator: John O'Donnell, M.B., B.S.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Smith & Nephew, Inc. Identifier: NCT01562366    
Other Study ID Numbers: SM-2012-01
First Posted: March 23, 2012    Key Record Dates
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:
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Pathologic Processes