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

NCT01562366 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2017-05-25

No results posted yet for this study

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

Interventions

DEVICE

Topaz

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

PROCEDURE

Iliotibial band release and trochanteric bursectomy

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

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • John O'Donnell, M.B., B.S.

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01562366 on ClinicalTrials.gov