NCT01562366

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 23, 2012

Completed
9 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

May 25, 2017

Status Verified

May 1, 2017

Enrollment Period

4.5 years

First QC Date

March 22, 2012

Last Update Submit

May 23, 2017

Conditions

Greater Trochanteric Pain SyndromeHip Pain Chronic

Keywords

Iliotibial Band ReleaseTrochanteric BursectomyMicro debridement

Outcome Measures

Primary Outcomes (1)

  • Modified Harris Hip Score

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

    6 months

Secondary Outcomes (6)

  • The Western Ontario and McMaster Universities Arthritis Index

    1 year

  • Visual Analogue Scale

    1 year

  • SF-12 Health Survey

    1 year

  • Duration of surgery between two treatment groups

    1 day

  • Ultrasound findings

    1 year

  • +1 more secondary outcomes

Study Arms (2)

Group 1

EXPERIMENTAL
Device: Topaz

Group 2

ACTIVE COMPARATOR
Procedure: Iliotibial band release and trochanteric bursectomy

Interventions

TopazDEVICE

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

Also known as: Topaz AC-4045-01
Group 1
Iliotibial band release and trochanteric bursectomyPROCEDURE

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

Also known as: Standard of Care
Group 2

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Abductor tears
  • Severe tendinopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Epworth Private Hospital

Richmond, Victoria, 3121, Australia

Location

Related Publications (1)

  • 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.

    PMID: 32047828DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • John O'Donnell, M.B., B.S.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2012

First Posted

March 23, 2012

Study Start

April 1, 2012

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

May 25, 2017

Record last verified: 2017-05

Locations

AU(1)