Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| MCRA | INDUSTRY |
Not provided
Not provided
Not provided
The goal of this clinical trial is to evaluate the safety and analgesic performance of the ReneuRxâ„¢ device in subjects with moderate to severe chronic lateral hip pain compared to subjects receiving treatment with corticosteroid injection in adults aged 22-80 years. Participants will attend study visits and complete quality of life questionnaires. Participants will be followed for approximately 6-12 months after the study procedure.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triamcinolone acetate | Active Comparator | Corticosteroid injection |
|
| ReneuRx | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone acetate | Drug | A single dose of Triamcinolone 40mg injected directly into the hip joint. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness | The primary endpoint of this study is the proportion of subjects whose hip pain following activity (Timed Up and Go test) is reduced by ≥30% based on the NRS scale at 3 months post treatment | 3-months post treatment |
| Primary Safety | Aggregate serious device-related adverse events through final follow-up visit | Through study completion, an average of 12-months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Effectiveness | Numeric Rating Scales - The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. With 0 being no pain and 10 being the most pain. | Baseline, Day 7, 1-Month, 2-Month, 3-Month, 4-Month, 5-Month, 6-Month, 12-Month |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Endpoint | Patient Specific Functional Scale (PSFS) The Patient-Specific Functional Scale (PSFS) assesses a subject's functional ability to complete an activity. Activities will be rated on an 11-point scale (0-10), where 0 indicates "unable to perform activity" and 10 indicates "able to perform activity at the same level as before injury or problem." The activities will be chosen and approved by both the subject and investigator. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Curd | Contact | 314-480-2244 | david.curd@brixtonbio.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Healthcare Outcomes Performance Company | Sun City | Arizona | 85023 | United States |
Not provided
MULTI-CENTER, RANDOMIZED, CONTROLLED STUDY
Not provided
Not provided
Not provided
| ReneuRx | Device | ReneuRx will be injected around the trochanteric branches of the femoral nerve. |
|
| Secondary Effectiveness | Patient Global Impressions Scale (PGIC) The Patient Global Impression of Change (PGIC) score is a self-reported measure used to assess a patient's perception of their overall improvement or worsening in health status following a specific treatment. It is often used in clinical trials and research studies to gauge the efficacy of interventions from the patient's perspective. The PGIC typically ranges from "very much worse" to "very much improved". | 3 month and 6 month post-treatment |
| Secondary Effectiveness | VISA-G (Victorian Institute of Sports Assessment-Gluteal Score) The Victorian Institute of Sport Assessment (VISA-) Gluteal (G) Questionnaire is a self-report clinical outcome measure used in patients with greater trochanteric pain syndrome (GTPS). It consists of eight questions that measure the domains of pain, function in daily living, and sports activities The VISA-G can be used to evaluate the functional impairment of a patient with a disorder of one or both lower extremities. It can be used to monitor the patient over time and to evaluate the effectiveness of an intervention. | Baseline, Day 7, 1-Month, 2-Month, 3-Month, 4-Month, 5-Month, 6-Month, 12-Month |
| Secondary Effectiveness | Change in Timed-Up and Go (TUG) test scores | 12 months post-treatment |
| Pain Relief | Onset of pain relief defined as time in days to pain reduced by 30% based on NRS score from baseline. | 6-Month, 12-Month |
| 12 months post-treatment |
| Exploratory Endpoints | Patient-Reported Outcome Measurement Information System (PROMIS) 29 score The PROMIS-29 v2. 0 profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. | 12 months post-treatment |
| Emory Orthopedics and Spine Center | Johns Creek | Georgia | 30097 | United States |
|
| Ochsner Health Center | New Orleans | Louisiana | 70121 | United States |
|
| Skylight Health Research | Burlington | Massachusetts | 01803 | United States |
|
| Mass General Brigham | Chestnut Hill | Massachusetts | 02467 | United States |
|
| Virtua Health | Sewell | New Jersey | 08080 | United States |
|
| The Orthopaedic Center | Tulsa | Oklahoma | 74137 | United States |
|
| Rothman Orthopaedics | King of Prussia | Pennsylvania | 19406 | United States |
|
| Pain Diagnostics & Interventional Care | Sewickley | Pennsylvania | 15143 | United States |
|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
|
| All-American Orthopedic & Sports | Houston | Texas | 77058 | United States |
|
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided