Clinical trial NCT01562366: 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
Overall status: COMPLETED
Phase: NA
Conditions: Greater Trochanteric Pain Syndrome
Hip Pain Chronic
Keywords: Iliotibial Band Release
Trochanteric Bursectomy
Micro debridement
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-23
Enrollment: 66
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: Modified Harris Hip Score
timeFrame: 6 months
Secondary outcomes:
measure: The Western Ontario and McMaster Universities Arthritis Index
timeFrame: 1 year
measure: Visual Analogue Scale
timeFrame: 1 year
measure: SF-12 Health Survey
timeFrame: 1 year
measure: Duration of surgery between two treatment groups
timeFrame: 1 day
measure: Ultrasound findings
timeFrame: 1 year
measure: Adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Richmond
country: Australia
facility: Epworth Private Hospital
state: Victoria
Study officials:
name: John O'Donnell, M.B., B.S.
role: PRINCIPAL_INVESTIGATOR
References:
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.