NCT03009890

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 4, 2017

Completed
28 days until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

5.8 years

First QC Date

December 22, 2016

Last Update Submit

January 16, 2023

Conditions

Radius Distal Fracture

Keywords

elderlyintra articularRCT

Outcome Measures

Primary Outcomes (1)

  • PRWE

    Patient-Rated Wrist Evaluation score

    12 months

Secondary Outcomes (3)

  • DASH

    12 months

  • EQ/5D

    12 months

  • PCS

    12 months

Other Outcomes (4)

  • ROM

    12 months

  • grip strength

    12 months

  • Radiographic parameters

    6 months

  • +1 more other outcomes

Study Arms (2)

Open reduction internal fixation

EXPERIMENTAL

Surgical open reduction internal fixation (ORIF)

Procedure: Surgery (Open Reduction Internal Fixation)

Plaster immobilization

ACTIVE COMPARATOR

Standard local hospital protocol for cast treatment

Procedure: Cast treatment

Interventions

Surgery (Open Reduction Internal Fixation)PROCEDURE

Either volar of dorsal plating or both

Also known as: ORIF Open Reduction Internal Fixation
Open reduction internal fixation
Cast treatmentPROCEDURE

Hospitals may use their preferred protocol

Also known as: Plaster
Plaster immobilization

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • \> 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

You may not qualify if:

  • Open fractures
  • Neurovascular damage
  • Multiple-trauma patients (ISS \>16)
  • Other fractures in the injured extremity other than ulnar styloid process fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Onze Lieve Vrouwe Gasthuis

Amsterdam, North Holland, 1090 HM, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 35365511DERIVED

Related Links

MeSH Terms

Conditions

Wrist Fractures

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Rudolf W Poolman, Prof. MD PhD

    OLVG, Amsterdam, the Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2016

First Posted

January 4, 2017

Study Start

February 1, 2017

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

January 18, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

Locations

NL(1)