NCT00955734

Brief Summary

Many surgeons pursue volar plating of the distal radius to allow earlier post-operative wrist motion. Early motion is generally prescribed in the belief that it will result in greater final motion without compromising fixation. However, studies have failed to demonstrate clinically significant improvement in final wrist motion (\> 1 year follow up) compared to treatments requiring longer immobilization such as external fixation or bridge plating.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2009

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 10, 2009

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 29, 2015

Status Verified

June 1, 2015

Enrollment Period

6 years

First QC Date

August 7, 2009

Last Update Submit

June 26, 2015

Conditions

Radius Fracture

Keywords

wristfracturemotionsurgery

Outcome Measures

Primary Outcomes (1)

  • Wrist Motion

    2 weeks - 1 year

Secondary Outcomes (3)

  • Patient Function

    2 weeks - 1 year

  • Patient Pain

    2 weeks - 1 year

  • Fracture reduction

    2 week - 1 year

Study Arms (2)

Early motion

EXPERIMENTAL

This group of patients will begin wrist motion 1 week after surgery.

Other: Early motion

Immobilization

ACTIVE COMPARATOR

This group will be casted for 6 weeks after surgery

Other: Immobilization

Interventions

Early motionOTHER

One set of patients will begin wrist motion at 1 week after surgery.

Early motion
ImmobilizationOTHER

This set of patients will be casted for 6 weeks after surgery.

Immobilization

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults over 18 years of age having volar internal fixation for distal radius fractures.

You may not qualify if:

  • Patients will be excluded if immobilization is required for distal radioulnar joint instability (whether operatively pinned or simply immobilized in supination) or an associated carpal injury.
  • Patients with concurrent fracture of the ulna proximal to the base of the ulnar styloid will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Radius FracturesFractures, Bone

Interventions

Immobilization

Condition Hierarchy (Ancestors)

Forearm InjuriesArm InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Ryan Calfee, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Orthopaedic Surgery

Study Record Dates

First Submitted

August 7, 2009

First Posted

August 10, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 29, 2015

Record last verified: 2015-06

Locations

US(1)