Surgery vs. Casting for Displaced Articular Radius Fractures in Elderly (DART)

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.

Study Overview

• Status: Completed
• Conditions: Radius Distal Fracture
• Intervention / Treatment: Procedure: Surgery (Open Reduction Internal Fixation); Procedure: Cast treatment

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 Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord Holland
    • Amsterdam, Noord Holland, Netherlands, 1090 hm
      • Onze Lieve Vrouwe Gasthuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open reduction internal fixation; Surgical open reduction internal fixation (ORIF)	Procedure: Surgery (Open Reduction Internal Fixation); Either volar of dorsal plating or both; Other Names: ORIF Open Reduction Internal Fixation
Active Comparator: Plaster immobilization; Standard local hospital protocol for cast treatment	Procedure: Cast treatment; Hospitals may use their preferred protocol; Other Names: Plaster

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PRWE	Patient-Rated Wrist Evaluation score	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DASH	Disability of the Arm, Shoulder and Hand	12 months
EQ/5D	Quality of life	12 months
PCS	Pain Catastrophizing Scale	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ROM	range of motion	12 months
grip strength	grip strength of both wrists	12 months
Radiographic parameters	Radial inclination, volar/dorsal tilt, ulnar variance, gap, step off and radial length	6 months
Complications	Complications of either treatment arm	12 months

Collaborators and Investigators

• Sponsor: JointResearch
• Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Maasstad Hospital; Deventer Ziekenhuis
• Investigators: Principal Investigator: Rudolf W Poolman, Prof. MD PhD, OLVG, Amsterdam, the Netherlands

Publications and helpful links

General 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.

Helpful Links

• website

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: December 22, 2016
• First Submitted That Met QC Criteria: January 2, 2017
• First Posted (Estimate): January 4, 2017

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 16, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: elderly; RCT; intra articular
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: NL56858.100.16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No