Greater Trochanteric Pain SyndromeNCT01562366
Research Study to Compare the Addition of Topaz Micro Debridement to the Standard of Care Surgery
A study testing Topaz and Iliotibial band release and trochanteric bursectomy in people with Greater Trochanteric Pain Syndrome and Hip Pain Chronic, run by Smith & Nephew, Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Greater Trochanteric Pain Syndrome, Hip Pain Chronic
- What is being tested?
- Topaz and Iliotibial band release and trochanteric bursectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2012to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Being tested
- Topaz, Iliotibial band release and trochanteric bursectomy
- Keywords
- Iliotibial Band Release, Trochanteric Bursectomy, Micro debridement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopazDevice
Also called Topaz AC-4045-01
Radiofrequency micro debridement with Topaz will be used to treat the gluteal tendons following standard of care procedure
Iliotibial band release and trochanteric bursectomyProcedure or surgery
Also called Standard of Care
Standard of Care: An iliotibial band release and trochanteric bursectomy will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Device: Topaz |
| Group 2 | Active comparator | Not described Receives: Procedure: Iliotibial band release and trochanteric bursectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Harris Hip Score
This is a patient questionnaire used to evaluate hip function following surgery.
Measured: 6 months
Secondary outcomes (6)
The Western Ontario and McMaster Universities Arthritis Index
This is a patient questionnaire used to evaluate rheumatic symptoms, stiffness, pain and how it affects the ability to function.
Measured: 1 year
Visual Analogue Scale
This is a patient questionnaire designed to evaluate pain.
Measured: 1 year
SF-12 Health Survey
This is a patient questionnaire measuring health-related quality of life.
Measured: 1 year
Duration of surgery between two treatment groups
The total length (time) of surgery will be compared between the two groups.
Measured: 1 day
Ultrasound findings
Measured: 1 year
Adverse events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Greater Trochanteric Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John O'Donnell, M.B., B.S., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562366
- Sponsor's protocol ID
- SM-2012-01
- Status last verified
- May 2017
- First submitted
- 22 Mar 2012
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32047828
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01562366
- Acronym / sponsor ID
- SM-2012-01
- Keywords
- Iliotibial Band Release, Trochanteric Bursectomy, Micro debridement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 23 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Topaz |
| Group 2 | Active comparator | Procedure: Iliotibial band release and trochanteric bursectomy |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TopazAlso: Topaz AC-4045-01Radiofrequency micro debridement with Topaz will be used to treat the gluteal tendons following standard of care procedure | Device | Group 1 |
| Iliotibial band release and trochanteric bursectomyAlso: Standard of CareStandard of Care: An iliotibial band release and trochanteric bursectomy will be performed. | Procedure or surgery | Group 2 |
Primary outcome
Modified Harris Hip Score
Time frame: 6 months
This is a patient questionnaire used to evaluate hip function following surgery.
6 secondary outcomes
The Western Ontario and McMaster Universities Arthritis Index
Time frame: 1 year
Visual Analogue Scale
Time frame: 1 year
SF-12 Health Survey
Time frame: 1 year
Duration of surgery between two treatment groups
Time frame: 1 day
Ultrasound findings
Time frame: 1 year
Adverse events
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
- Derived from this study: PubMed 32047828Blakey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John O'Donnell, M.B., B.S. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topaz and Iliotibial band release and trochanteric bursectomy in people with Greater Trochanteric Pain Syndrome and Hip Pain Chronic, run by Smith & Nephew, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Harris Hip Score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01562366, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2017.