Lets Agree to Disagree on Operative vs Nonoperative Treatment for Distal Radius Fractures in the Elderly (LADON Radius)

NCT05631314 | Not Yet Recruiting

• 1 other identifier: LADON radius
• Study Type: observational
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

distal radius fracture; elderly; operative treatment; natural experiment

Outcome Measures

Primary Outcomes (1)

• PRWE 12 weeks

  Patient-rated Wrist Evaluation scores measured a t 12 weeks after treatment initiation

  12 weeks

Secondary Outcomes (8)

• PRWE 1 and 2 years

  1 year, 2 years

• PASE

  12 weeks, 1 year, 2 years

• Pain intensity

  6 weeks, 12 weeks, 1 year, 2 years

• range of motion

  12 weeks, 1 year, 2 years

• EQ-5D-5L

  12 weeks, 1 year, 2 years

Study Arms (2)

operative treatment

This group will consist of patients who underwent operative treatment for a distal radius fracture.

Procedure: operative treatment

non-operative treatment

This group will consist of patients who underwent non-operative treatment for a distal radius fracture.

Procedure: non-operative treatment

Interventions

operative treatment PROCEDURE

Operative treatment can consist of open reduction and volar and/or dorsal plating or closed reduction and fixation with K-wires, external fixateur.

operative treatment

non-operative treatment PROCEDURE

Non-operative treatment will consist of immobilization in a below the elbow cast for 4-6 weeks with or without prior closed reduction.

non-operative treatment

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the emergency department or out-patient clinic in one of the participating hospitals.

You may qualify if:

• ≥ 65 years old
• acute (\< 14 days after injury) distal radius fracture
• treated at one of the participating hospitals

You may not qualify if:

• initial operative treatment at a non-participating hospital
• delayed presentation (\>14 days after injury)
• patient actively refuses the recommended treatment
• insufficient follow-up (\<12 months) or unavailable to follow-up due to residency in other hospital area
• concomitant injury to the ipsilateral or contralateral upper extremity
• cognitive impairment precluding answering questionnaires
• non-German, non-English, non-Dutch speaking
• pre-existing co-morbidities which preclude operative treatment
• pathological fractures
• open fractures
• neurovascular injury requiring operative treatment

Sponsors & Collaborators

• Luzerner Kantonsspital: lead
• Arthrex GmbH: collaborator

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Frank JP Beeres, PD PhD

  Luzerner Kantonsspital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole M van Veelen, MD

CONTACT

041412051959; nicole.vanveelen@luks.ch

Frank JP Beeres, PD PhD

CONTACT

+41412051914; frank.beeres@luks.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: November 30, 2022
• Study Start: February 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: February 1, 2026
• Last Updated: November 30, 2022

Record last verified: 2022-11