NCT01333371

Brief Summary

Patients will be randomized to volar plating with early ROM versus closed reduction with K-wires and 6 weeks of cast immobilization to determine if there is any advantage to volar plating in this subgroup of patients with distal radius fractures.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2011

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 12, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 12, 2011

Status Verified

April 1, 2011

Enrollment Period

2.9 years

First QC Date

April 8, 2011

Last Update Submit

April 11, 2011

Conditions

Distal Radius Fracture

Keywords

Distal RadiusVolar locked platingCost EffectivenessRandomizationOutcomes

Outcome Measures

Primary Outcomes (1)

  • Patient Rated Wrist Evaluation

    Questionnaire administered to assess subjective levels of pain and function

    Prior to randomization and at 3, 6, and 12 months following randomization

Secondary Outcomes (1)

  • Objective measures

    3, 6, and 12 months following surgery

Study Arms (2)

closed reduction with percutaneous k-wire fixation and casted

ACTIVE COMPARATOR
Procedure: Surgical Repair of Distal Radius Fracture

open reduction internal fixation with a volar locked plate

ACTIVE COMPARATOR
Procedure: Surgical Repair of Distal Radius Fracture

Interventions

Surgical Repair of Distal Radius FracturePROCEDURE

2 surgical methods to treat Distal Radius Fracture

closed reduction with percutaneous k-wire fixation and castedopen reduction internal fixation with a volar locked plate

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Distal radius fracture - AO type A or C1
  • Skeletally mature
  • Age 18-65 years old
  • Isolated injury

You may not qualify if:

  • AO Type B or C2,3
  • Other injuries involving affected or unaffected arm
  • Skeletally immature

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hand and Upper Limb Clinic, St Joseph's Health Care

London, Ontario, N6A4L6, Canada

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Ruby Grewal, MD, FRCSC

    Hand and Upper Limb Clinic, St. Joseph's Health Care

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruby Grewal, MD, FRCSC

CONTACT

519-646-6286ruby.greal@sjhc.london.on.ca

Chris A Young, B.A

CONTACT

519-646-6100chris.young@sjhc.london.on.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK

Study Record Dates

First Submitted

April 8, 2011

First Posted

April 12, 2011

Study Start

April 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

April 12, 2011

Record last verified: 2011-04

Locations

CA(1)