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

Smith & Nephew

Status: Completed

Conditions: Hip Pain Chronic; Greater Trochanteric Pain Syndrome

Treatments: Procedure: Iliotibial band release and trochanteric bursectomy; Device: Topaz

Study type: Interventional

Funder types: Industry

Identifiers

NCT01562366

SM-2012-01

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups

Group 1

Experimental group

Treatment:

Device: Topaz

Group 2

Active Comparator group

Treatment:

Procedure: Iliotibial band release and trochanteric bursectomy