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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by ArthroCare Corporation
Sponsor:
Information provided by (Responsible Party):
ArthroCare Corporation
ClinicalTrials.gov Identifier:
NCT01562366
First received: March 22, 2012
Last updated: June 6, 2014
Last verified: June 2014

March 22, 2012
June 6, 2014
April 2012
December 2014   (final data collection date for primary outcome measure)
Modified Harris Hip Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
This is a patient questionnaire used to evaluate hip function following surgery.
Same as current
Complete list of historical versions of study NCT01562366 on ClinicalTrials.gov Archive Site
  • The Western Ontario and McMaster Universities Arthritis Index [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    This is a patient questionnaire designed to evaluate pain.
  • SF-12 Health Survey [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    This is a patient questionnaire measuring health-related quality of life.
  • Duration of surgery between two treatment groups [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The total length (time) of surgery will be compared between the two groups.
  • Ultrasound findings [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Health Services Research
  • Greater Trochanteric Pain Syndrome
  • Hip Pain
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
66
June 2015
December 2014   (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
Both
40 Years to 70 Years
No
Contact: Jackie Amador, BA (512) 895-1094 jackie.amador@arthrocare.com
Contact: Ilona Andresen, BS (512)-391-3956 ilona.andresen@arthrocare.com
Australia
 
NCT01562366
SM-2012-01
No
ArthroCare Corporation
ArthroCare Corporation
Not Provided
Principal Investigator: John O'Donnell, M.B., B.S., FRACS, FAOA
ArthroCare Corporation
June 2014

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