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

Not yet recruiting
Conditions
Radius Fracture Distal
Interventions
Procedure: operative treatment
Procedure: non-operative treatment
Registration Number
NCT05631314
Lead Sponsor
Luzerner Kantonsspital
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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
110
Inclusion Criteria
  • ≥ 65 years old
  • acute (< 14 days after injury) distal radius fracture
  • treated at one of the participating hospitals
Read More
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
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
operative treatmentoperative treatmentThis group will consist of patients who underwent operative treatment for a distal radius fracture.
non-operative treatmentnon-operative treatmentThis group will consist of patients who underwent non-operative treatment for a distal radius fracture.
Primary Outcome Measures
NameTimeMethod
PRWE 12 weeks12 weeks

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

Secondary Outcome Measures
NameTimeMethod
Complications6 weeks, 12 weeks, 1 year, 2 years

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.

PRWE 1 and 2 years1 year, 2 years

Patient-rated Wrist Evaluation scores measured 1 and 2 years after treatment initiation

Pain intensity6 weeks, 12 weeks, 1 year, 2 years

numeric rating system for pain

living situation6 weeks, 12 weeks, 1 year, 2 years

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.

radiological outcome6 weeks, 12 weeks, 1 year, 2 years

The xrays will be assessed to judge the radiological outcome with regards to loss of reduction.

range of motion12 weeks, 1 year, 2 years

range of motion of the wrist

PASE12 weeks, 1 year, 2 years

Physical activity score of the elderly

EQ-5D-5L12 weeks, 1 year, 2 years

Quality of life score

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