Lets Agree to Disagree on Operative vs Nonoperative Treatment for Distal Radius Fractures in the Elderly (LADON Radius)
NCT05631314 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 110
Last updated 2022-11-30
Summary
The primary objective of this study is to determine if non-operative treatment of distal radius fractures in patients aged 65 and over leads to equal funtional results as operative treatment. To do so patients will be included from two "schools" in which treatment i seither predominantly operative or non-operative. There will be no study intervention as patients will be treated as per local standard of care. The study is set up as an international multicenter study. Those patients included in the study will be follow-up at 6 weeks, 12 weeks, 1 year and 2 years after treatment was initiated. Our hypothesis is, that patients treated operatively will have better function than those treated non-operatively.
Conditions
- Radius Fracture Distal
Interventions
- PROCEDURE
-
operative treatment
Operative treatment can consist of open reduction and volar and/or dorsal plating or closed reduction and fixation with K-wires, external fixateur.
- PROCEDURE
-
non-operative treatment
Non-operative treatment will consist of immobilization in a below the elbow cast for 4-6 weeks with or without prior closed reduction.
Sponsors & Collaborators
-
Arthrex GmbH
collaborator INDUSTRY -
Luzerner Kantonsspital
lead OTHER
Principal Investigators
-
Frank JP Beeres, PD PhD · Luzerner Kantonsspital
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-02-28
- Primary Completion
- 2024-05-31
- Completion
- 2026-02-28
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