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Early Mobilization Following Volar Locking Plate Fixation of Distal Radius Fractures

NCT05033938 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-09-05

No results posted yet for this study

Summary

The overall purpose of this study is to establish the utility of early mobilization in improving patient satisfaction following plate and screw fixation of wrist fractures. Subjects will have objective range of motion data collected and subjective survey data collected at 2 weeks, 6 weeks, 3 months, and 1 year after being randomized either to an early mobilization group that receives a removable wrist splint or a late mobilization group that is placed in a splint for 2 weeks post-operatively. The investigators expect that early wrist mobilization following locking plate fixation of wrist fractures will lead to an increase in postoperative patient satisfaction without a significant increase in complications.

Conditions

  • Distal Radius Fracture

Interventions

PROCEDURE

Early Mobilization Protocol

Subjects will be placed in a bulky soft dressing immediately after surgery. They will be made non-weight bearing, but active and passive motion of digits, forearm, elbow, and shoulder will be allowed with light functional tasks permitted as tolerated. Wrist motion within the soft dressing will be permitted as tolerated by patient. On postoperative day 3, patients will be advised to remove the dressing at home and begin home hand/wrist therapy. They will use a removable Velcro wrist splint for nighttime wear and strenuous activity. This splint can be removed during normal activities of daily living and therapy.

PROCEDURE

Late Mobilization Protocol

Subjects will be placed in a plaster volar resting splint. They will be made non-weight bearing, with use of digits for light functional tasks permitted. They will be given home exercises for their fingers but will not yet resume wrist motion

Sponsors & Collaborators

  • Brielle Orthopedics

    collaborator UNKNOWN

  • Universtiy Orthopedics Associates

    collaborator UNKNOWN

  • Robert Wood Johnson Barnabas Health

    lead OTHER

Principal Investigators

  • Bobby Varghese, MD · Research Assistant

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-05
Primary Completion
2022-04-01
Completion
2023-04-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05033938 on ClinicalTrials.gov