CompletedNot Applicable

External Fixation Vs. Volar Plate for Distal Radius Fractures: Functional Outcomes

Nepal42 participantsStarted 2019-12-23

Plain-language summary

The goal of this prospective comparative clinical trial is to evaluate the effectiveness of external fixation versus volar locking plates in the management of unstable intra-articular distal radius fractures in adults over 18 years old. The main questions it aims to answer are: Does the use of a volar locking plate result in better functional outcomes, as measured by the Green and O'Brien scoring system modified by Cooney, compared to external fixation? What are the differences in intraoperative and postoperative parameters, including complications, between the two methods? Researchers will compare outcomes in two groups: one receiving external fixation and the other undergoing open reduction and internal fixation with volar locking plates. Participants will: Undergo surgical intervention (external fixation or ORIF with volar plates) performed by experienced orthopedic surgeons. Follow a postoperative rehabilitation plan, including active and passive range of motion exercises. Attend follow-ups at 6, 12, and 24 weeks to assess pain, range of motion, fracture union, and complications.

Who can participate

Age range

18 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: * Patients aged 18 years or older. * Diagnosed with recent (\<1 week) intra-articular distal end radius fractures. * Willing and able to provide informed consent. Exclusion Criteria: * Open fractures classified as Gustilo grade II or higher. * Fracture avulsion or dislocation. * Vascular injury associated with the fracture. * Extra-articular fractures of the distal radius. * Preexisting joint or carpal bone disease affecting rehabilitation. * Patients unwilling to provide consent.

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

Functional Outcomes Assessed by the Green and O'Brien Scoring System Modified by Cooney

Timeframe: 24 weeks post-surgery

Trial details

NCT IDNCT06738693

SponsorB.P. Koirala Institute of Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-09-12

View on ClinicalTrials.gov More Radius Fractures trials