TerminatedNot Applicable

Distal Radius Fracture - Treatment Comparison

Stopped: Low Enrollment

United States9 participantsStarted 2013-07

Plain-language 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.

Who can participate

Age range65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in Composite Patient Outcomes Over Time

Timeframe: Data will be collected at 2, 6, 12, 26, 52 weeks

Trial details

NCT IDNCT01883063

SponsorSonoma Orthopedic Products, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-12