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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental |
| |
| Group 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topaz | Device | Radiofrequency micro debridement with Topaz will be used to treat the gluteal tendons following standard of care procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Harris Hip Score | This is a patient questionnaire used to evaluate hip function following surgery. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Visual Analogue Scale |
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Inclusion Criteria:
Exclusion Criteria:
Intra-operative Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| John O'Donnell, M.B., B.S. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Epworth Private Hospital | Richmond | Victoria | 3121 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32047828 | Derived | 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. |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Iliotibial band release and trochanteric bursectomy | Procedure | Standard of Care: An iliotibial band release and trochanteric bursectomy will be performed. |
|
|
This is a patient questionnaire designed to evaluate pain.
| 1 year |
| SF-12 Health Survey | This is a patient questionnaire measuring health-related quality of life. | 1 year |
| Duration of surgery between two treatment groups | The total length (time) of surgery will be compared between the two groups. | 1 day |
| Ultrasound findings | 1 year |
| Adverse events | 1 year |