Surgery vs. Casting for Displaced Articular Radius Fractures in Elderly

Radius Distal Fracture Clinical Trial

— DART  

Official title:

The Effectiveness of Surgery Versus Casting for Elderly Patients With Displaced Distal Intra-Articular Radius Fractures: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03009890
• Other study ID #: NL56858.100.16
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: November 1, 2022

Study information

• Verified date: January 2023
• Source: JointResearch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• > 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

• Fit for surgery

• Mentally competent

• Dutch fluency and literacy

• Informed consent

Exclusion Criteria:

• Open fractures

• Neurovascular damage

• Multiple-trauma patients (ISS >16)

• Other fractures in the injured extremity other than ulnar styloid process fractures

Related Conditions & MeSH terms

• Fractures, Bone
• Radius Distal Fracture
• Radius Fractures

Intervention

Procedure:
• Surgery (Open Reduction Internal Fixation)
Either volar of dorsal plating or both
• Cast treatment
Hospitals may use their preferred protocol

Locations

Country	Name	City	State
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam	Noord Holland

Sponsors (4)

Lead Sponsor	Collaborator
JointResearch	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Deventer Ziekenhuis, Maasstad Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ROM	range of motion	12 months
Other	grip strength	grip strength of both wrists	12 months
Other	Radiographic parameters	Radial inclination, volar/dorsal tilt, ulnar variance, gap, step off and radial length	6 months
Other	Complications	Complications of either treatment arm	12 months
Primary	PRWE	Patient-Rated Wrist Evaluation score	12 months
Secondary	DASH	Disability of the Arm, Shoulder and Hand	12 months
Secondary	EQ/5D	Quality of life	12 months
Secondary	PCS	Pain Catastrophizing Scale	12 months

External Links

•   website