Minimally Displaced Intra-articular Distal Radius Fracture
Conditions
Brief summary
This is a prospective multi-site study. Subjects with distal radius fractures will be enrolled. Subjects will be treated surgically with a Sonoma WRx™ 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.
Interventions
DEVICESurgical Treatment
Patients will be treated for distal radius fractures surgically with a WRx™ Intramedullary Nail
DEVICENon surgical Treatment (Cast or splint)
Patients will be treated for distal radius fractures non surgically with a cast or splint
Sponsors
Sonoma Orthopedic Products, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Closed extra-articular distal radius fracture or a minimally displaced intra-articular fracture * Fracture classified as an AO/OTA A2, A3, C1 or C2 with or without an ulnar styloid fracture * Must be treated within the first 14 days of injury, * Male or female greater than or equal to 65 years of age. * Able to understand the requirements of the study, provide a written informed consent and comply with the study protocol * Ability to understand and provide written authorization for use and disclosure of personal health information * Fracture that can be treated closed with or without closed reduction
Exclusion criteria
* Concomitant contralateral or ipsilateral upper extremity fractures * Ipsilateral ulna (excluding styloid) fracture * Open fracture * Previous ipsilateral distal radius fracture in the 2 years prior to enrollment with deformity * Unstable distal radioulnar joint after fracture fixation * Fractures where the transverse fracture line is less than 10mm from the distal radius joint surface * Artery or Nerve injury secondary to fracture * History of alcoholism * Currently on chemotherapy or radiation therapy * Currently on worker's compensation * Rheumatoid arthritis or other inflammatory arthropathies. * History of chronic pain issues or psychiatric disorder that precludes reliable follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Composite Patient Outcomes Over Time | Data will be collected at 2, 6, 12, 26, 52 weeks | Patient outcomes will be measured with the DASH, PRWE and a patient questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Composite Functional Outcomes Over Time | Data will be collected at 2, 6, 12, 26, 52 weeks | Measurements of range of motion, strength and fracture healing will be used to determine functional outcomes. |
Countries
United States
Outcome results
None listed