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

NCT ID: NCT05631314

Last Updated: 2022-11-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2026-02-28

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.

Detailed Description

This study is an international multicenter prospective observational cohort study for which patients will be identified after treatment has been initiated. Outcome data will be prospectively collected. Patients will be recruited from five hospitals in countries with a predominant preference for operative (Switzerland, "School" A) and non-operative treatment (the Netherlands, "School" B). After a treatment plan has been established, patients will be approached either during the index hospital admission or during one of their follow-up appointments in the outpatient clinic within six weeks to explain the purpose and procedures of the study. Patients will be asked to provide written informed consent. Following the identification of eligible patients, anonymous radiographs including key images of CT-scans if available and baseline characteristics (such as age, co-morbidities, activity level) as well as relevant laboratory results will be made available to the expert panel (details below) on a secure online platform. This will allow the members of the panel to reach a "clinical" decision regarding their treatment recommendation. The panel will be blinded to the actual treatment received and the origin of the case.

The expert panel will consist of three representatives from both "Schools". All panel members will be certified trauma surgeons from one of the participating hospitals. Eligible patients will be reviewed by the experts every two weeks. Patients will ultimately be included in the study if clinical equipoise is achieved, meaning the majority of experts in one "School", minimally two out of three, disagree with the received treatment in the other "School". For example, eligible patients would have received operative treatment based on the expert opinions in "School" A, however, were in fact treated non-operatively according to the treating surgeon in "School" B and vice versa. If the majority of the panel in one "School" agree with the received treatment in the other "School" the patient will be excluded. This will lead to two comparable groups for which true clinical equipoise exists. The actual treatment the patient receives, will continue as initially planned by the treating hospital.

Conditions

Radius Fracture Distal

Keywords

distal radius fracture; elderly; operative treatment; natural experiment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

operative treatment

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

operative treatment

Intervention Type: PROCEDURE

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

non-operative treatment

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

non-operative treatment

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arthrex GmbH

INDUSTRY

Sponsor Role: collaborator

Luzerner Kantonsspital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank JP Beeres, PD PhD

Role: PRINCIPAL_INVESTIGATOR

Luzerner Kantonsspital

Central Contacts

Nicole M van Veelen, MD

Role: CONTACT

Phone: 041412051959

Email: nicole.vanveelen@luks.ch

Frank JP Beeres, PD PhD

Role: CONTACT

Phone: +41412051914

Email: frank.beeres@luks.ch

Other Identifiers

LADON radius

Identifier Type: -

Identifier Source: org_study_id