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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Radius Fracture Distal

Intervention / Treatment
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* Procedure: operative treatment
* Procedure: non-operative treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| operative treatment<br>This group will consist of patients who underwent operative treatment for a distal radius fracture. | Procedure: operative treatment<br>* Operative treatment can consist of open reduction and volar and/or dorsal plating or closed reduction and fixation with K-wires, external fixateur.<br>|
| non-operative treatment<br>This group will consist of patients who underwent non-operative treatment for a distal radius fracture. | Procedure: non-operative treatment<br>* Non-operative treatment will consist of immobilization in a below the elbow cast for 4-6 weeks with or without prior closed reduction.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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distal radius fracture, elderly, operative treatment, natural experiment