Clinical trial NCT05631314: Lets Agree to Disagree on Operative vs Nonoperative Treatment for Distal Radius Fractures in the Elderly (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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Radius Fracture Distal
Keywords: distal radius fracture
elderly
operative treatment
natural experiment
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
Collaborators: name: Arthrex GmbH
First posted: 2022-11-30
Enrollment: 110
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the emergency department or out-patient clinic in one of the participating hospitals.

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.

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

Primary outcomes:
measure: PRWE 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: PRWE 1 and 2 years
timeFrame: 1 year, 2 years
measure: PASE
timeFrame: 12 weeks, 1 year, 2 years
measure: Pain intensity
timeFrame: 6 weeks, 12 weeks, 1 year, 2 years
measure: range of motion
timeFrame: 12 weeks, 1 year, 2 years
measure: EQ-5D-5L
timeFrame: 12 weeks, 1 year, 2 years
measure: Complications
timeFrame: 6 weeks, 12 weeks, 1 year, 2 years
measure: living situation
timeFrame: 6 weeks, 12 weeks, 1 year, 2 years
measure: radiological outcome
timeFrame: 6 weeks, 12 weeks, 1 year, 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Luzerner Kantonsspital
name: Frank JP Beeres, PD PhD
role: PRINCIPAL_INVESTIGATOR
References: