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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.

March 22, 2012
March 23, 2012
May 25, 2017
April 2012
October 2016   (Final data collection date for primary outcome measure)
Modified Harris Hip Score [ Time Frame: 6 months ]
This is a patient questionnaire used to evaluate hip function following surgery.
Same as current
Complete list of historical versions of study NCT01562366 on Archive Site
  • 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.
  • Visual Analogue Scale [ Time Frame: 1 year ]
    This is a patient questionnaire designed to evaluate pain.
  • SF-12 Health Survey [ Time Frame: 1 year ]
    This is a patient questionnaire measuring health-related quality of life.
  • Duration of surgery between two treatment groups [ Time Frame: 1 day ]
    The total length (time) of surgery will be compared between the two groups.
  • Ultrasound findings [ Time Frame: 1 year ]
  • Adverse events [ Time Frame: 1 year ]
Same as current
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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.
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
  • Greater Trochanteric Pain Syndrome
  • Hip Pain Chronic
  • 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
  • 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
  • Experimental: Group 1
    Intervention: Device: Topaz
  • Active Comparator: Group 2
    Intervention: Procedure: Iliotibial band release and trochanteric bursectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2016
October 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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Smith & Nephew, Inc.
Smith & Nephew, Inc.
Not Provided
Principal Investigator: John O'Donnell, M.B., B.S.
Smith & Nephew, Inc.
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP