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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01562366




Registration number
NCT01562366
Ethics application status
Date submitted
22/03/2012
Date registered
23/03/2012
Date last updated
25/05/2017

Titles & IDs
Public title
Research Study to Compare the Addition of Topaz Micro Debridement to the Standard of Care Surgery
Scientific 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
Secondary ID [1] 0 0
SM-2012-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Greater Trochanteric Pain Syndrome 0 0
Hip Pain Chronic 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Topaz
Treatment: Surgery - Iliotibial band release and trochanteric bursectomy

Experimental: Group 1 -

Active Comparator: Group 2 -


Treatment: Devices: Topaz
Radiofrequency micro debridement with Topaz will be used to treat the gluteal tendons following standard of care procedure

Treatment: Surgery: Iliotibial band release and trochanteric bursectomy
Standard of Care: An iliotibial band release and trochanteric bursectomy will be performed.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Modified Harris Hip Score
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
The Western Ontario and McMaster Universities Arthritis Index
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Visual Analogue Scale
Timepoint [2] 0 0
1 year
Secondary outcome [3] 0 0
SF-12 Health Survey
Timepoint [3] 0 0
1 year
Secondary outcome [4] 0 0
Duration of surgery between two treatment groups
Timepoint [4] 0 0
1 day
Secondary outcome [5] 0 0
Ultrasound findings
Timepoint [5] 0 0
1 year
Secondary outcome [6] 0 0
Adverse events
Timepoint [6] 0 0
1 year

Eligibility
Key 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
Minimum age
40 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Health Services Research
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2016
Sample size
Target
Accrual to date
Final
66
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Epworth Private Hospital - Richmond
Recruitment postcode(s) [1] 0 0
3121 - Richmond

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Smith & Nephew, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01562366
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John O'Donnell, M.B., B.S.
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01562366