Radius Fracture DistalLADON radiusNCT05631314
Lets Agree to Disagree on Operative vs Nonoperative Treatment for Distal Radius Fractures in the Elderly (LADON Radius)
An observational study of Radius Fracture Distal, run by Luzerner Kantonsspital.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Radius Fracture Distal
- What is being tested?
- operative treatment and non-operative treatment
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients presenting to the emergency department or out-patient clinic in one of the participating hospitals.
Who may be able to join
- ≥ 65 years old
- acute (< 14 days after injury) distal radius fracture
- treated at one of the participating hospitals
Who cannot join
- 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
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- non-German, non-English, non-Dutch speaking
- pre-existing co-morbidities which preclude operative treatment
- pathological fractures
- open fractures
- neurovascular injury requiring operative treatment
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Radius Fracture Distal
- Being tested
- operative treatment, non-operative treatment
- Keywords
- distal radius fracture, elderly, operative treatment, natural experiment
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
operative treatmentProcedure or surgery
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 treatmentProcedure or surgery
Non-operative treatment will consist of immobilization in a below the elbow cast for 4-6 weeks with or without prior closed reduction.
| Study group | Role | What they receive |
|---|---|---|
| operative treatment | This group will consist of patients who underwent operative treatment for a distal radius fracture. Receives: Procedure: operative treatment | |
| non-operative treatment | This group will consist of patients who underwent non-operative treatment for a distal radius fracture. Receives: Procedure: non-operative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRWE 12 weeks
Patient-rated Wrist Evaluation scores measured a t 12 weeks after treatment initiation
Measured: 12 weeks
Secondary outcomes (8)
PRWE 1 and 2 years
Patient-rated Wrist Evaluation scores measured 1 and 2 years after treatment initiation
Measured: 1 year, 2 years
PASE
Physical activity score of the elderly
Measured: 12 weeks, 1 year, 2 years
Pain intensity
numeric rating system for pain
Measured: 6 weeks, 12 weeks, 1 year, 2 years
range of motion
range of motion of the wrist
Measured: 12 weeks, 1 year, 2 years
EQ-5D-5L
Quality of life score
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks, 12 weeks, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study startFeb 2023 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radius Fracture DistalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Collaborators
- Arthrex GmbH
- Responsible party
- Sponsor
- Investigators
- Frank JP Beeres, PD PhD, Principal investigator, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631314
- Sponsor's protocol ID
- LADON radius
- Acronym
- LADON radius
- Status last verified
- Nov 2022
- First submitted
- 21 Nov 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05631314
- Acronym / sponsor ID
- LADON radius / LADON radius
- Conditions
- Radius Fracture Distal
- Keywords
- distal radius fracture, elderly, operative treatment, natural experiment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Collaborators
- Arthrex GmbH
- Study start
- Feb 2023 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| operative treatment | – | Procedure: operative treatmentThis group will consist of patients who underwent operative treatment for a distal radius fracture. |
| non-operative treatment | – | Procedure: non-operative treatmentThis group will consist of patients who underwent non-operative treatment for a distal radius fracture. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients presenting to the emergency department or out-patient clinic in one of the participating hospitals.
Key inclusion criteria (3 listed)
- ≥ 65 years old
- acute (< 14 days after injury) distal radius fracture
- treated at one of the participating hospitals
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| operative treatmentOperative treatment can consist of open reduction and volar and/or dorsal plating or closed reduction and fixation with K-wires, external fixateur. | Procedure or surgery | operative treatment |
| non-operative treatmentNon-operative treatment will consist of immobilization in a below the elbow cast for 4-6 weeks with or without prior closed reduction. | Procedure or surgery | non-operative treatment |
Primary outcome
PRWE 12 weeks
Time frame: 12 weeks
Patient-rated Wrist Evaluation scores measured a t 12 weeks after treatment initiation
8 secondary outcomes
PRWE 1 and 2 years
Time frame: 1 year, 2 years
PASE
Time frame: 12 weeks, 1 year, 2 years
Pain intensity
Time frame: 6 weeks, 12 weeks, 1 year, 2 years
range of motion
Time frame: 12 weeks, 1 year, 2 years
EQ-5D-5L
Time frame: 12 weeks, 1 year, 2 years
Complications
Time frame: 6 weeks, 12 weeks, 1 year, 2 years
living situation
Time frame: 6 weeks, 12 weeks, 1 year, 2 years
radiological outcome
Time frame: 6 weeks, 12 weeks, 1 year, 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank JP Beeres, PD PhD principal investigator
Luzerner Kantonsspital
Questions about this trial
What is this clinical trial studying?
An observational study of Radius Fracture Distal, run by Luzerner Kantonsspital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicole M van Veelen, MD (041412051959, nicole.vanveelen@luks.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PRWE 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.