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

No results posted yet for this study

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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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 NCT05631314 on ClinicalTrials.gov