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

Sponsor
Smith & Nephew, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01562366
Collaborator
(none)
66
Enrollment
1
Location
2
Arms
54
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

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
  • Device: Topaz
  • Procedure: Iliotibial band release and trochanteric bursectomy
 N/A

Study Design

Study Type:
Interventional
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 :
Apr 1, 2012
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Oct 1, 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 Names:
  • 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 Names:
  • Standard of Care

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Modified Harris Hip Score [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 [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 [1 year]

      This is a patient questionnaire designed to evaluate pain.

    3. SF-12 Health Survey [1 year]

      This is a patient questionnaire measuring health-related quality of life.

    4. Duration of surgery between two treatment groups [1 day]

      The total length (time) of surgery will be compared between the two groups.

    5. Ultrasound findings [1 year]

    6. Adverse events [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 70 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Epworth Private Hospital Richmond Victoria Australia 3121

    Sponsors and Collaborators

    • Smith & Nephew, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Smith & Nephew, Inc.
    ClinicalTrials.gov Identifier:
    NCT01562366
    Other Study ID Numbers:
    • SM-2012-01
    First Posted:
    Mar 23, 2012
    Last Update Posted:
    May 25, 2017
    Last Verified:
    May 1, 2017
    Keywords provided by Smith & Nephew, Inc.
    Iliotibial Band Release
    Trochanteric Bursectomy
    Micro debridement
    Additional relevant MeSH terms:
    Bursitis
    Syndrome

    Study Results

    No Results Posted as of May 25, 2017