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OpenTrials
Completed

NCT Number: NCT01562366

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

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.

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Epworth Private Hospital

Richmond, Victoria, 3121, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female or male aged between 40-70 years old, females and males are eligible
  • 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
  • Pre-operative MRI and ultrasound with evidence of GTPS within the previous 24 weeks
  • Willing to comply with the protocol and follow-up visits
  • Signed the Independent Ethics Committee (IEC) approved Informed Consent Form

Exclusion criteria

  • Previous surgery to the hip such as hip replacement, fracture neck of femur fixation, or repair of gluteal tendons
  • Subjects with sero-positive or sero-negative arthropathy
  • Long term steroid use > 6 weeks
  • Allergy to drugs to be used in the procedure
  • Medical co-morbidities that preclude surgical intervention
  • Inability to understand or respond to the study questionnaires
  • Females who are pregnant, or pregnancy is suspected or planned within the clinical investigation timeframe
  • Subjects who are simultaneously participating in another device or pharmaceutical investigation

Intra-operative Exclusion:

  • Abductor tears
  • Severe tendinopathy

Treatment and study plan

Topaz

Device

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

Other names: Topaz AC-4045-01

Iliotibial band release and trochanteric bursectomy

Procedure

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

Other names: Standard of Care

Primary outcomes

  1. Modified Harris Hip Score

    Time frame: 6 months

    This is a patient questionnaire used to evaluate hip function following surgery.

Secondary outcomes

  1. The Western Ontario and McMaster Universities Arthritis Index

    Time frame: 1 year

    This is a patient questionnaire used to evaluate rheumatic symptoms, stiffness, pain and how it affects the ability to function.

  2. Visual Analogue Scale

    Time frame: 1 year

    This is a patient questionnaire designed to evaluate pain.

  3. SF-12 Health Survey

    Time frame: 1 year

    This is a patient questionnaire measuring health-related quality of life.

  4. Duration of surgery between two treatment groups

    Time frame: 1 day

    The total length (time) of surgery will be compared between the two groups.

  5. Ultrasound findings

    Time frame: 1 year

  6. Adverse events

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Smith & Nephew, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 23, 2012
Registry last updated
May 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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