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

Radius Fracture Distal Clinical Trial

— LADON radius  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05631314
• Other study ID #: LADON radius
• Status: Not yet recruiting
• Start date: February 2023
• Est. completion date: February 2026

Study information

• Verified date: November 2022
• Source: Luzerner Kantonsspital
• Contact: Nicole M van Veelen, MD
• Phone: 041412051959
• Email: nicole.vanveelen[@]luks.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: February 2026
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Radius Fracture Distal
• Radius Fractures

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Luzerner Kantonsspital	Arthrex GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PRWE 12 weeks	Patient-rated Wrist Evaluation scores measured a t 12 weeks after treatment initiation	12 weeks
Secondary	PRWE 1 and 2 years	Patient-rated Wrist Evaluation scores measured 1 and 2 years after treatment initiation	1 year, 2 years
Secondary	PASE	Physical activity score of the elderly	12 weeks, 1 year, 2 years
Secondary	Pain intensity	numeric rating system for pain	6 weeks, 12 weeks, 1 year, 2 years
Secondary	range of motion	range of motion of the wrist	12 weeks, 1 year, 2 years
Secondary	EQ-5D-5L	Quality of life score	12 weeks, 1 year, 2 years
Secondary	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
Secondary	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
Secondary	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