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Low Enrollment
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This is a prospective multi-site study. Subjects with distal radius fractures will be enrolled. Subjects will be treated surgically with a Sonoma WRxâ„¢ device or managed non-operatively with a splint or cast. Subjects will be enrolled in each group according to physician's standard of care (either casting/splinting or surgery) for distal radius fractures. Subjects will be enrolled based on the study's inclusion/exclusion criteria with a final qualifying decision made by a group of three independent adjudicators. The final qualifying review should allow for similar patient groups within each arm of the study due to the variability that can arise in fracture classification. Review by the adjudicators should be completed within 1 week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WRxâ„¢ Intramedullary Nail | Experimental | Patients in this arm of the study will be treated with a minimally invasive WRxâ„¢ Intramedullary Nail for their wrist fracture. |
|
| Non surgical treatment (Cast) | Active Comparator | Patients in this arm of the study will be treated with a cast for their wrist fracture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical Treatment | Device | Patients will be treated for distal radius fractures surgically with a WRxâ„¢ Intramedullary Nail |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Composite Patient Outcomes Over Time | Patient outcomes will be measured with the DASH, PRWE and a patient questionnaire. | Data will be collected at 2, 6, 12, 26, 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Composite Functional Outcomes Over Time | Measurements of range of motion, strength and fracture healing will be used to determine functional outcomes. | Data will be collected at 2, 6, 12, 26, 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cadence Health | Winfield | Illinois | 60190 | United States | ||
| University of Missouri |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 16, 2016 | |
| Reset | May 23, 2016 | |
| Release | Oct 12, 2016 | |
| Reset | Dec 5, 2016 | |
| Release | Apr 28, 2017 | |
| Unrelease | Yes |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 16, 2016 | May 23, 2016 | |||
| Oct 12, 2016 |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D013165 | Splints |
| ID | Term |
|---|---|
| D016267 | External Fixators |
| D009984 | Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
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| Non surgical Treatment (Cast or splint) | Device | Patients will be treated for distal radius fractures non surgically with a cast or splint |
|
| Columbia |
| Missouri |
| 65211 |
| United States |
| John Peter Smith Hospital | Fort Worth | Texas | 76107 | United States |
| Dec 5, 2016 |
| Apr 28, 2017 | Yes |
| D004864 |
| Equipment and Supplies |
| D053831 | Surgical Fixation Devices |