Surgery vs. Casting for Displaced Articular Radius Fractu... | NCT03009890

Studies
Surgery vs. Casting for Displaced Articular Radius Fractures in Elderly

NCT03009890

Sponsor

JointResearch

Status

Completed

Last Update Posted

Jan 18, 2023Actual

Enrollment

138Actual

Phase

Not Applicable

Conditions

Radius Distal Fracture

Interventions

Surgery (Open Reduction Internal Fixation)
Cast treatment

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2017Actual

Primary Completion Date

Nov 1, 2022Actual

Completion Date

Nov 1, 2022Actual

First Submitted Date

Dec 22, 2016

First Submission Date that Met QC Criteria

Jan 2, 2017

First Posted Date

Jan 4, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2023

Last Update Posted Date

Jan 18, 2023Actual

Name	Class
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	OTHER
Maasstad Hospital	OTHER
Deventer Ziekenhuis	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

138Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Surgery (Open Reduction Internal Fixation)	Procedure	Either volar of dorsal plating or both	Open reduction internal fixation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Measure	Description	Time Frame
ROM	range of motion	12 months
grip strength	grip strength of both wrists	12 months

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rudolf W Poolman, Prof. MD PhD	OLVG, Amsterdam, the Netherlands	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Onze Lieve Vrouwe Gasthuis		Amsterdam	North Holland	1090 HM	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35365511	Derived	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.

ID	Term
D014954	Wrist Injuries
D001134	Arm Injuries
D014947	Wounds and Injuries
D050723	Fractures, Bone