Distal Radius Fracture - Treatment Comparison
| Status: | Terminated |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 10/14/2017 |
| Start Date: | July 2013 |
| End Date: | December 2014 |
PATIENT OUTCOME COMPARISON OF INTRAMEDULLARY LOCKED NAILING VERSUS NONOPERATIVE MANAGEMENT OF EXTRA-ARTICULAR AND MINIMALLY DISPLACED INTRA-ARTICULAR DISTAL RADIUS FRACTURES IN THE ELDERLY
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.
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.
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.
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