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
  Purpose

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 Intervention Phase
Greater Trochanteric Pain Syndrome
Hip Pain
Device: Topaz
Procedure: Iliotibial band release and trochanteric bursectomy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by ArthroCare Corporation:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 66
Study Start Date: April 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01562366

Contacts
Contact: Jackie Amador, BA (512) 895-1094 jackie.amador@arthrocare.com
Contact: Ilona Andresen, BS (512)-391-3956 ilona.andresen@arthrocare.com

Locations
Australia, Victoria
Epworth Private Hospital Recruiting
Richmond, Victoria, Australia, 3121
Contact: Jess O'Donnell    0412920786    research@johnodonnell.com.au   
Principal Investigator: John O'Donnell, M.B, B.S. FRACS FAOA         
Sub-Investigator: Parminder J Singh, M.B., B.S.,MRCS, FRCS, MS         
Sponsors and Collaborators
ArthroCare Corporation
Investigators
Principal Investigator: John O'Donnell, M.B., B.S., FRACS, FAOA
  More Information

No publications provided

Responsible Party: ArthroCare Corporation
ClinicalTrials.gov Identifier: NCT01562366     History of Changes
Other Study ID Numbers: SM-2012-01
Study First Received: March 22, 2012
Last Updated: June 6, 2014
Health Authority: Australia: International Standards Organization
Australia: Independent Ethics Committee

Keywords provided by ArthroCare Corporation:
Iliotibial Band Release
Trochanteric Bursectomy
Micro debridement

Additional relevant MeSH terms:
Somatoform Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 01, 2014