Radius Distal FractureDARTNCT03009890
Surgery vs. Casting for Displaced Articular Radius Fractures in Elderly
A study testing Surgery (Open Reduction Internal Fixation) and Cast treatment in people with Radius Distal Fracture, run by JointResearch at 1 site in Netherlands.
Trial summary
Objective: to compare the functional outcome after open reduction and internal fixation with non-operative cast treatment for elderly patients with displaced intra-articular distal radius fractures. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Radius Distal Fracture
- What is being tested?
- Surgery (Open Reduction Internal Fixation) and Cast treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Feb 2017to 1 Nov 2022
- Phase
- Interventional
- 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
Who may be able to join
- > 65 years at time of trauma
- Intra-articular distal radius fracture (AO type C*)
- One or more of the following fracture characteristics within 3 weeks post-trauma (including secondary dislocation):
- ≤15° inclination <5 mm radial length >15° dorsal tilt >20° volar tilt intra-articular gap or step-off >2 mm
- < 3 weeks post trauma
- Living independent
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- Fit for surgery
- Mentally competent
- Dutch fluency and literacy
- Informed consent
Who cannot join
- Open fractures
- Neurovascular damage
- Multiple-trauma patients (ISS >16)
- Other fractures in the injured extremity other than ulnar styloid process fractures
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Onze Lieve Vrouwe Gasthuis
Amsterdam, North Holland, 1090 HM
About this study
Official title: The Effectiveness of Surgery Versus Casting for Elderly Patients With Displaced Distal Intra-Articular Radius Fractures: A Randomized Controlled Trial
Objective: to compare the functional outcome after open reduction and internal fixation with non-operative cast treatment for elderly patients with displaced intra-articular distal radius fractures.
Read the detailed description
Rationale: there is no consensus about the optimal treatment of displaced intra-articular distal radius fractures in elderly patients. To ensure optimal functional outcome there is a tendency to operate. However, there is no evidence that supports the surgical treatment of patients aged 65 years or older and in the absence of clinical trials it stays unclear how elderly patients with intra-articular fractures should be treated.
Study design: multi-center randomized controlled trial with a non-inferiority design. Economic evaluation alongside a randomized controlled multi-center trial.
Study population: all consecutive patients aged between 65 years and older with displaced intra-articular (AO Type C) distal radius fractures, with a not acceptable reduction within 3 weeks following trauma.
Intervention: patients will be randomized between open reduction and internal fixation (intervention group) and plaster immobilization (control group).
Main study parameters: the primary outcome will be evaluated after 1 year with the Patient-Rated Wrist Evaluation score (PRWE). Secondary outcomes comprise other patient reported outcome measures (PROM) including the Disability of the Arm, Shoulder and Hand (DASH), Quality of life (EQ-5D) and Pain Catastrophizing Scale (PCS). Further outcome measurements comprise a costs evaluation questionnaire, range of motion (ROM), grip strength, radiographic parameters and Complications.
- Conditions
- Radius Distal Fracture
- Being tested
- Surgery (Open Reduction Internal Fixation), Cast treatment
- Keywords
- elderly, intra articular, RCT
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery (Open Reduction Internal Fixation)Procedure or surgery
Also called ORIF Open Reduction Internal Fixation
Either volar of dorsal plating or both
Cast treatmentProcedure or surgery
Also called Plaster
Hospitals may use their preferred protocol
| Study group | Role | What they receive |
|---|---|---|
| Open reduction internal fixation | Experimental | Surgical open reduction internal fixation (ORIF) Receives: Procedure: Surgery (Open Reduction Internal Fixation) |
| Plaster immobilization | Active comparator | Standard local hospital protocol for cast treatment Receives: Procedure: Cast treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRWE
Patient-Rated Wrist Evaluation score
Measured: 12 months
Secondary outcomes (3)
DASH
Disability of the Arm, Shoulder and Hand
Measured: 12 months
EQ/5D
Quality of life
Measured: 12 months
PCS
Pain Catastrophizing Scale
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study start1 Feb 2017
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radius Distal FractureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- JointResearch
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Maasstad Hospital, Deventer Ziekenhuis
- Responsible party
- Sponsor
- Investigators
- Rudolf W Poolman, Prof. MD PhD, Principal investigator, OLVG, Amsterdam, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009890
- Sponsor's protocol ID
- NL56858.100.16
- Acronym
- DART
- Status last verified
- Jan 2023
- First submitted
- 22 Dec 2016
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Ter Meulen DP, Mulders MAM, Kruiswijk AA, Kret EJ, Slichter ME, van Dongen JM, Kerkhoffs GMMJ, Goslings JC, Kleinlugtenbelt YV, Willigenburg NW, Schep NWL, Poolman RW; DART Study Group. Effectiveness and cost-effectiveness of surgery versus casting for elderly patients with Displaced intra-Articular type C distal Radius fractures: protocol of a randomised controlled Trial with economic evaluation (the DART study). BMJ Open. 2022 Apr 1;12(4):e051658. doi: 10.1136/bmjopen-2021-051658.
PubMed 35365511
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Surgery Versus Casting for Elderly Patients With Displaced Distal Intra-Articular Radius Fractures: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03009890
- Acronym / sponsor ID
- DART / NL56858.100.16
- Conditions
- Radius Distal Fracture
- Keywords
- elderly, intra articular, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- JointResearchUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Maasstad Hospital, Deventer Ziekenhuis
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 4 Jan 2017 (estimated)
- 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.
Objective: to compare the functional outcome after open reduction and internal fixation with non-operative cast treatment for elderly patients with displaced intra-articular distal radius fractures.
Detailed description
Rationale: there is no consensus about the optimal treatment of displaced intra-articular distal radius fractures in elderly patients. To ensure optimal functional outcome there is a tendency to operate. However, there is no evidence that supports the surgical treatment of patients aged 65 years or older and in the absence of clinical trials it stays unclear how elderly patients with intra-articular fractures should be treated.
Study design: multi-center randomized controlled trial with a non-inferiority design. Economic evaluation alongside a randomized controlled multi-center trial.
Study population: all consecutive patients aged between 65 years and older with displaced intra-articular (AO Type C) distal radius fractures, with a not acceptable reduction within 3 weeks following trauma.
Intervention: patients will be randomized between open reduction and internal fixation (intervention group) and plaster immobilization (control group).
Main study parameters: the primary outcome will be evaluated after 1 year with the Patient-Rated Wrist Evaluation score (PRWE). Secondary outcomes comprise other patient reported outcome measures (PROM) including the Disability of the Arm, Shoulder and Hand (DASH), Quality of life (EQ-5D) and Pain Catastrophizing Scale (PCS). Further outcome measurements comprise a costs evaluation questionnaire, range of motion (ROM), grip strength, radiographic parameters and Complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open reduction internal fixation | Experimental | Procedure: Surgery (Open Reduction Internal Fixation)Surgical open reduction internal fixation (ORIF) |
| Plaster immobilization | Active comparator | Procedure: Cast treatmentStandard local hospital protocol for cast treatment |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- > 65 years at time of trauma
- Intra-articular distal radius fracture (AO type C*)
- One or more of the following fracture characteristics within 3 weeks post-trauma (including secondary dislocation):
- ≤15° inclination <5 mm radial length >15° dorsal tilt >20° volar tilt intra-articular gap or step-off >2 mm
- < 3 weeks post trauma
Key exclusion criteria (4 listed)
- Open fractures
- Neurovascular damage
- Multiple-trauma patients (ISS >16)
- Other fractures in the injured extremity other than ulnar styloid process fractures
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 |
|---|---|---|
| Surgery (Open Reduction Internal Fixation)Also: ORIF Open Reduction Internal FixationEither volar of dorsal plating or both | Procedure or surgery | Open reduction internal fixation |
| Cast treatmentAlso: PlasterHospitals may use their preferred protocol | Procedure or surgery | Plaster immobilization |
Primary outcome
PRWE
Time frame: 12 months
Patient-Rated Wrist Evaluation score
3 secondary outcomes
DASH
Time frame: 12 months
EQ/5D
Time frame: 12 months
PCS
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Derived from this study: PubMed 35365511Ter Meulen DP, Mulders MAM, Kruiswijk AA, Kret EJ, Slichter ME, van Dongen JM, Kerkhoffs GMMJ, Goslings JC, Kleinlugtenbelt YV, Willigenburg NW, Schep NWL, Poolman RW; DART Study Group. Effectiveness and cost-effectiveness of surgery versus casting for elderly patients with Displaced intra-Articular type C distal Radius fractures: protocol of a randomised controlled Trial with economic evaluation (the DART study). BMJ Open. 2022 Apr 1;12(4):e051658. doi: 10.1136/bmjopen-2021-051658.
- websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Rudolf W Poolman, Prof. MD PhD principal investigator
OLVG, Amsterdam, the Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery (Open Reduction Internal Fixation) and Cast treatment in people with Radius Distal Fracture, run by JointResearch at 1 site in Netherlands.
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 10 inclusion and 4 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: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PRWE (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03009890, which also lists 1 linked publication.
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 18 Jan 2023.