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 range

65 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Minimally Displaced Intra-articular Distal Radius Fracture trials