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

Lets Agree to Disagree on Operative Versus Nonoperative (LADON) Treatment for Distal Radius Fractures in the Elderly - a Prospective International Multicenter Cohort Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Radius Fracture Distal
• Intervention / Treatment: Procedure: operative treatment; Procedure: non-operative treatment

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.

• Study Type: Observational
• Enrollment (Anticipated): 110

Contacts and Locations

• Study Contact: Name: Nicole M van Veelen, MD; Phone Number: 041412051959; Email: nicole.vanveelen@luks.ch
• Study Contact Backup: Name: Frank JP Beeres, PD PhD; Phone Number: +41412051914; Email: frank.beeres@luks.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
operative treatment; This group will consist of patients who underwent operative treatment for a distal radius fracture.	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.
non-operative treatment; This group will consist of patients who underwent non-operative treatment for a distal radius fracture.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PRWE 12 weeks	Patient-rated Wrist Evaluation scores measured a t 12 weeks after treatment initiation	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PRWE 1 and 2 years	Patient-rated Wrist Evaluation scores measured 1 and 2 years after treatment initiation	1 year, 2 years
PASE	Physical activity score of the elderly	12 weeks, 1 year, 2 years
Pain intensity	numeric rating system for pain	6 weeks, 12 weeks, 1 year, 2 years
range of motion	range of motion of the wrist	12 weeks, 1 year, 2 years
EQ-5D-5L	Quality of life score	12 weeks, 1 year, 2 years
Complications	Complications will be assessed. They will include infection, non-union, implant failure, complex regional pain syndrome and any adverse event need surgical intervention. For patients treated surgically, the need for implant removal will also be recorded.	6 weeks, 12 weeks, 1 year, 2 years
living situation	the living situation of the patient will be assessed and classified as one of the following categories: independent, independent with support from family/district nurse or similar, nursing home.	6 weeks, 12 weeks, 1 year, 2 years
radiological outcome	The xrays will be assessed to judge the radiological outcome with regards to loss of reduction.	6 weeks, 12 weeks, 1 year, 2 years

Collaborators and Investigators

• Sponsor: Luzerner Kantonsspital
• Collaborators: Arthrex GmbH
• Investigators: Principal Investigator: Frank JP Beeres, PD PhD, Luzerner Kantonsspital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): February 1, 2026

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: elderly; distal radius fracture; natural experiment; operative treatment
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: LADON radius

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No