Back to resultsResearch Study to Compare the Addition of Topaz Micro Debridement to the Standard of Care Surgery
Primary Purpose
Greater Trochanteric Pain Syndrome, Hip Pain Chronic
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Topaz
Iliotibial band release and trochanteric bursectomy
Sponsored by
About this trial
This is an interventional health services research trial for Greater Trochanteric Pain Syndrome focused on measuring Iliotibial Band Release, Trochanteric Bursectomy, Micro debridement
Eligibility Criteria
Inclusion Criteria:
- Female or male aged between 40-70 years old, females and males are eligible
- 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
- Pre-operative MRI and ultrasound with evidence of GTPS within the previous 24 weeks
- Willing to comply with the protocol and follow-up visits
- Signed the Independent Ethics Committee (IEC) approved Informed Consent Form
Exclusion Criteria:
- Previous surgery to the hip such as hip replacement, fracture neck of femur fixation, or repair of gluteal tendons
- Subjects with sero-positive or sero-negative arthropathy
- Long term steroid use > 6 weeks
- Allergy to drugs to be used in the procedure
- Medical co-morbidities that preclude surgical intervention
- Inability to understand or respond to the study questionnaires
- Females who are pregnant, or pregnancy is suspected or planned within the clinical investigation timeframe
- Subjects who are simultaneously participating in another device or pharmaceutical investigation
Intra-operative Exclusion:
- Abductor tears
- Severe tendinopathy
Sites / Locations
- Epworth Private Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
Outcomes
Primary Outcome Measures
Modified Harris Hip Score
This is a patient questionnaire used to evaluate hip function following surgery.
Secondary Outcome Measures
The Western Ontario and McMaster Universities Arthritis Index
This is a patient questionnaire used to evaluate rheumatic symptoms, stiffness, pain and how it affects the ability to function.
Visual Analogue Scale
This is a patient questionnaire designed to evaluate pain.
SF-12 Health Survey
This is a patient questionnaire measuring health-related quality of life.
Duration of surgery between two treatment groups
The total length (time) of surgery will be compared between the two groups.
Ultrasound findings
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01562366
Brief Title
Research Study to Compare the Addition of Topaz Micro Debridement to the Standard of Care Surgery
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 Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smith & Nephew, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Greater Trochanteric Pain Syndrome, Hip Pain Chronic
Keywords
Iliotibial Band Release, Trochanteric Bursectomy, Micro debridement
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Title
Group 2
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Topaz
Other Intervention Name(s)
Topaz AC-4045-01
Intervention Description
Radiofrequency micro debridement with Topaz will be used to treat the gluteal tendons following standard of care procedure
Intervention Type
Procedure
Intervention Name(s)
Iliotibial band release and trochanteric bursectomy
Other Intervention Name(s)
Standard of Care
Intervention Description
Standard of Care: An iliotibial band release and trochanteric bursectomy will be performed.
Primary Outcome Measure Information:
Title
Modified Harris Hip Score
Description
This is a patient questionnaire used to evaluate hip function following surgery.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The Western Ontario and McMaster Universities Arthritis Index
Description
This is a patient questionnaire used to evaluate rheumatic symptoms, stiffness, pain and how it affects the ability to function.
Time Frame
1 year
Title
Visual Analogue Scale
Description
This is a patient questionnaire designed to evaluate pain.
Time Frame
1 year
Title
SF-12 Health Survey
Description
This is a patient questionnaire measuring health-related quality of life.
Time Frame
1 year
Title
Duration of surgery between two treatment groups
Description
The total length (time) of surgery will be compared between the two groups.
Time Frame
1 day
Title
Ultrasound findings
Time Frame
1 year
Title
Adverse events
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female or male aged between 40-70 years old, females and males are eligible
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
Pre-operative MRI and ultrasound with evidence of GTPS within the previous 24 weeks
Willing to comply with the protocol and follow-up visits
Signed the Independent Ethics Committee (IEC) approved Informed Consent Form
Exclusion Criteria:
Previous surgery to the hip such as hip replacement, fracture neck of femur fixation, or repair of gluteal tendons
Subjects with sero-positive or sero-negative arthropathy
Long term steroid use > 6 weeks
Allergy to drugs to be used in the procedure
Medical co-morbidities that preclude surgical intervention
Inability to understand or respond to the study questionnaires
Females who are pregnant, or pregnancy is suspected or planned within the clinical investigation timeframe
Subjects who are simultaneously participating in another device or pharmaceutical investigation
Intra-operative Exclusion:
Abductor tears
Severe tendinopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John O'Donnell, M.B., B.S.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Epworth Private Hospital
City
Richmond
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
32047828
Citation
Blakey CM, O'Donnell J, Klaber I, Singh P, Arora M, Takla A, Fitzpatrick J. Radiofrequency Microdebridement as an Adjunct to Arthroscopic Surgical Treatment for Recalcitrant Gluteal Tendinopathy: A Double-Blind, Randomized Controlled Trial. Orthop J Sports Med. 2020 Jan 24;8(1):2325967119895602. doi: 10.1177/2325967119895602. eCollection 2020 Jan.
Results Reference
derived
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Research Study to Compare the Addition of Topaz Micro Debridement to the Standard of Care Surgery
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