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Distal Radius Fracture - Treatment Comparison

NCT01883063 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2015-04-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Sonoma Orthopedic Products, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01883063 on ClinicalTrials.gov