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

NCT ID: NCT01562366

Last Updated: 2017-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2016-10-31

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.

Conditions

Greater Trochanteric Pain Syndrome; Hip Pain Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Group 1

Group Type: EXPERIMENTAL

Topaz

Intervention Type: DEVICE

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

Group 2

Group Type: ACTIVE_COMPARATOR

Iliotibial band release and trochanteric bursectomy

Intervention Type: PROCEDURE

Standard of Care: An iliotibial band release and trochanteric bursectomy will be performed.

Interventions

Topaz

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

Intervention Type: DEVICE

Iliotibial band release and trochanteric bursectomy

Standard of Care: An iliotibial band release and trochanteric bursectomy will be performed.

Intervention Type: PROCEDURE

Other Intervention Names

Topaz AC-4045-01; Standard of Care

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John O'Donnell, M.B., B.S.

Role: PRINCIPAL_INVESTIGATOR

Locations

Epworth Private Hospital

Richmond, Victoria, Australia

Countries

Australia

References

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.

Reference Type: DERIVED

PMID: 32047828 (View on PubMed)

Other Identifiers

SM-2012-01

Identifier Type: -

Identifier Source: org_study_id