NCT01883063

Distal Radius Fracture - Treatment Comparison

PATIENT OUTCOME COMPARISON OF INTRAMEDULLARY LOCKED NAILING VERSUS NONOPERATIVE MANAGEMENT OF EXTRA-ARTICULAR AND MINIMALLY DISPLACED INTRA-ARTICULAR DISTAL RADIUS FRACTURES IN THE ELDERLY

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Sonoma Orthopedic Products, Inc. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Minimally Displaced Intra-articular Distal Radius Fracture

Interventions

Type	Name	Description
DEVICE	Surgical Treatment	Patients will be treated for distal radius fractures surgically with a WRx™ Intramedullary Nail
DEVICE	Non surgical Treatment (Cast or splint)	Patients will be treated for distal radius fractures non surgically with a cast or splint

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-06-21
• Last updated: 2015-04-14

Locations

3 sites across 1 country: United States