NCT02990052

Brief Summary

A prospective, randomized controlled single-center trial with 80 patients aged 50 years and above to compare the functional and radiological results of conservative treatment and volar fixed-angle plating in the management of distal radius fracture

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2008

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

November 1, 2008

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 12, 2016

Completed
Last Updated

December 12, 2016

Status Verified

December 1, 2016

Enrollment Period

5.2 years

First QC Date

November 7, 2016

Last Update Submit

December 9, 2016

Conditions

Distal Radius Fractures

Outcome Measures

Primary Outcomes (1)

  • Difference of DASH-score between two study groups

    Disability of the Arm, Shoulder and Hand -Score assessing the function of the upper extremity

    2 year observation

Secondary Outcomes (1)

  • Difference of radiological parameters between two study groups

    2 year observation

Study Arms (2)

Volar plating

ACTIVE COMPARATOR

Volar fixed-angle plating for dislocated distal radius fracture after closed reduction.

Procedure: Volar plating

Conservative treatment

ACTIVE COMPARATOR

Primary conservative treatment (closed reduction and casting) for dislocated distal radius fracture.

Procedure: Conservative treatment

Interventions

Volar platingPROCEDURE

Open reduction and volar fixed-angle plate fixation of distal radius fracture

Volar plating
Conservative treatmentPROCEDURE

Closed reduction \& casting of distal radius fracture

Conservative treatment

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients over 50 years-old
  • primary dislocated distal radius fracture (AO/OTA 23 type A2-3 and C1-2)
  • primary reduction of fracture is acceptable considering primary conservative treatment

You may not qualify if:

  • bilateral and open fractures and fractures with neurovascular compromise
  • other major concurrent fracture necessitating treatment of any kind
  • patients under 50 years of age
  • previous ipsilateral distal radius fracture
  • inflammatory joint disease
  • significant radiocarpal-joint degeneration
  • patient's bad co-operation or major co-morbidity making an operation contraindicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wrist Fractures

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

Therapeutics

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

November 7, 2016

First Posted

December 12, 2016

Study Start

November 1, 2008

Primary Completion

January 1, 2014

Study Completion

January 1, 2016

Last Updated

December 12, 2016

Record last verified: 2016-12