NCT05033938

Brief 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.

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
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

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 5, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

September 5, 2021

Status Verified

August 1, 2021

Enrollment Period

12 months

First QC Date

July 22, 2021

Last Update Submit

August 27, 2021

Conditions

Distal Radius Fracture

Keywords

volar locking platewrist fractureplates and screws

Outcome Measures

Primary Outcomes (36)

  • Non-operative Hand Active Wrist Flexion

    Wrist on the non-operated hand is flexed by subject and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    6 weeks

  • Non-operative Hand Active Wrist Flexion

    Wrist on the non-operated hand is flexed by subject and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    3 months

  • Non-operative Hand Active Wrist Flexion

    Wrist on the non-operated hand is flexed by subject and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    1 year

  • Non-operative Hand Passive Wrist Flexion

    Wrist on the non-operated hand is flexed by the observer and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    6 weeks

  • Non-operative Hand Passive Wrist Flexion

    Wrist on the non-operated hand is flexed by the observer and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    3 Months

  • Non-operative Hand Passive Wrist Flexion

    Wrist on the non-operated hand is flexed by the observer and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    1 Year

  • Non-operative Hand Active Wrist Extension

    Wrist on the non-operated hand is extended by subject and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    6 weeks

  • Non-operative Hand Active Wrist Extension

    Wrist on the non-operated hand is extended by subject and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    3 Months

  • Non-operative Hand Active Wrist Extension

    Wrist on the non-operated hand is extended by subject and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    1 Year

  • Non-operative Hand Passive Wrist Extension

    Wrist on the non-operated hand is extended by the observer and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    6 weeks

  • Non-operative Hand Passive Wrist Extension

    Wrist on the non-operated hand is extended by the observer and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    3 Months

  • Non-operative Hand Passive Wrist Extension

    Wrist on the non-operated hand is extended by the observer and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    1 Year

  • Operative Hand Active Wrist Extension

    Wrist on the operated hand is extended by the subject and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    6 weeks

  • Operative Hand Active Wrist Extension

    Wrist on the operated hand is extended by the subject and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    3 Months

  • Operative Hand Active Wrist Extension

    Wrist on the operated hand is extended by the subject and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    1 Year

  • Operative Hand Passive Wrist Extension

    Wrist on the operated hand is extended by the observer and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    6 weeks

  • Operative Hand Passive Wrist Extension

    Wrist on the operated hand is extended by the observer and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    3 Months

  • Operative Hand Passive Wrist Extension

    Wrist on the operated hand is extended by the observer and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    1 Year

  • Operative Hand Active Wrist Flexion

    Wrist on the operated hand is flexed by the subject and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    6 weeks

  • Operative Hand Active Wrist Flexion

    Wrist on the operated hand is flexed by the subject and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    3 Months

  • Operative Hand Active Wrist Flexion

    Wrist on the operated hand is flexed by the subject and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    1 Year

  • Operative Hand Passive Wrist Flexion

    Wrist on the operated hand is flexed by the observer and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    6 weeks

  • Operative Hand Passive Wrist Flexion

    Wrist on the operated hand is flexed by the observer and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    3 Months

  • Operative Hand Passive Wrist Flexion

    Wrist on the operated hand is flexed by the observer and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    1 Year

  • Non-operative Hand Active Wrist Supination

    Wrist on the non-operated hand is actively supinated by the subject and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    6 Weeks

  • Non-operative Hand Active Wrist Supination

    Wrist on the non-operated hand is actively supinated by the subject and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    3 Months

  • Non-operative Hand Active Wrist Supination

    Wrist on the non-operated hand is actively supinated by the subject and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    1 Year

  • Non-operative Hand Passive Wrist Supination

    Wrist on the non-operated hand is passively supinated by the observer and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    6 Weeks

  • Non-operative Hand Passive Wrist Supination

    Wrist on the non-operated hand is passively supinated by the observer and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    3 Months

  • Non-operative Hand Passive Wrist Supination

    Wrist on the non-operated hand is passively supinated by the observer and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    1 Year

  • Operative Hand Active Wrist Supination

    Wrist on the operated hand is actively supinated by the subject and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    6 Weeks

  • Operative Hand Active Wrist Supination

    Wrist on the operated hand is actively supinated by the subject and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    3 months

  • Operative Hand Active Wrist Supination

    Wrist on the operated hand is actively supinated by the subject and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    1 Year

  • Operative Hand Passive Wrist Supination

    Wrist on the operated hand is passive supinated by the observer and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    6 Weeks

  • Operative Hand Passive Wrist Supination

    Wrist on the operated hand is passive supinated by the observer and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    3 Months

  • Operative Hand Passive Wrist Supination

    Wrist on the operated hand is passive supinated by the observer and joint angle is measured using a goniometer, a specialized protractor for measuring joint angles

    1 Year

Secondary Outcomes (50)

  • Radiographic evaluation of volar tilt

    2 weeks

  • Radiographic evaluation of volar tilt

    6 weeks

  • Radiographic evaluation of volar tilt

    3 Months

  • Radiographic evaluation of volar tilt

    1 Year

  • Radiographic evaluation of radial inclination

    2 Weeks

  • +45 more secondary outcomes

Study Arms (2)

Early Mobilization

ACTIVE COMPARATOR

Post-operatively subjects receive a removable wrist splint that can be taken off for early wrist mobilization

Procedure: Early Mobilization Protocol

Late Mobilization

ACTIVE COMPARATOR

Post-operatively subjects receive a splint and are not instructed to not move their wrist till the 2 week follow up visit.

Procedure: Late Mobilization Protocol

Interventions

Early Mobilization ProtocolPROCEDURE

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.

Early Mobilization
Late Mobilization ProtocolPROCEDURE

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

Late Mobilization

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DRF requiring volar plate fixation per physician investigator
  • No medical comorbidities which would prevent them from having surgery per physician investigator
  • Intra- or extra-articular DRF

You may not qualify if:

  • Open fractures
  • Comminuted fractures
  • Polytrauma
  • Bilateral DRFs
  • Previous contralateral wrist injury that could limit comparison
  • Pathologic fractures
  • Additional fixation methods utilized (dorsal plate, K-wire, external fixator, etc.)
  • Bone graft use
  • Inability to comply with treatment protocol or follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Orthopedics Associates

Somerset, New Jersey, 08873, United States

RECRUITING

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Bobby Varghese, MD

    Research Assistant

    STUDY DIRECTOR

Central Study Contacts

Bobby Varghese, MD

CONTACT

8324657112bv209@rwjms.rutgers.edu

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
Research Assistant

Study Record Dates

First Submitted

July 22, 2021

First Posted

September 5, 2021

Study Start

April 5, 2021

Primary Completion

April 1, 2022

Study Completion

April 1, 2023

Last Updated

September 5, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)