Early Mobilization Following Volar Locking Plate Fixation of Distal Radius Fractures

NCT ID: NCT05033938

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-05
• Study Completion Date: 2023-04-01

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.

Detailed Description

This study will be a prospective randomized clinical trial which will explore differences in outcomes between early and late mobilization in patients undergoing volar plate fixation of distal radius fractures (DRF). The data will be collected at two weeks, six weeks, three months, and one year postoperatively. Data will be collected utilizing questionnaires, in-office measurements, and radiographic evaluation.

Patients will be identified for potential enrollment to the study by physician investigators at Robert Wood Johnson University Hospital (RWJUH), Robert Wood Johnson Somerset, University Orthopaedic Associates, and St. Peter's University Hospital Center for Ambulatory Resources (CARES). Once enrolled to the study, patients will be randomized to the two study arms in an alternating fashion. Every other patient will be randomized to one of the two groups. A potential source of bias exists in the fact that the surgeon will not be able to be entirely blinded to which group the patient is assigned, as the postoperative dressing is different between the two, so the surgeon must know which dressing to apply. Once assigned to a group preoperatively, patients will be counseled on their postoperative rehabilitation program. They will be given a pamphlet detailing restrictions, exercises, and motions allowed at each specific time point.

The patients will undergo distal radius open reduction and internal fixation utilizing a volar locking plate. Either a modified Henry volar approach or a trans-flexor carpi radialis (FCR) approach to the distal radius will be used. The specific type and brand of plate will be recorded. Immediate post-operative radiographs will be acquired. Patients assigned to the early mobilization group will be given a Velcro removable wrist splint to go home with, measured off their contralateral hand. All patients in both groups will be administered 10 Percocet pills (5 mg/325 mg) for postoperative pain. Patient consumption of pain medication will be captured at subsequent visits starting at 2 weeks.

For the early mobilization group, patients 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 removeable Velcro wrist splint for nighttime wear and strenuous activity. This splint can be removed during normal activities of daily living (ADLs) and therapy. At this point, patients can shower without covering surgical site. However, soaking in standing water is not permitted. The first postoperative visit will be in 2 weeks. Sutures/staples will be removed if applicable. Patients will be advised to wean splint as tolerated with progressive weight bearing as pain permits. Patients will continue active and passive wrist motion exercises at home until 6 weeks post-op. From the 6-week timepoint onward, patients will have no restrictions. At the 6-week, 3 month, and 1 year postoperative visits, patients will have repeat radiographs taken, all measurements performed, and all questionnaires administered. All radiographs and visits for this study are standard of care. These data points are outlined below.

For the late mobilization group, immediately post-operatively patients 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. At the first post-operative visit at the 2-week timepoint, the dressing and volar splint will be removed, along with sutures/staples if applicable. Patients will be converted to removeable Velcro wrist splint for nighttime and strenuous activity, which can be removed during normal ADLs and therapy. Patients will be given a list of home exercises to be performed as a pamphlet. Patients will be advised to wean splint as tolerated with progressive weight bearing as pain permitted. They will continue active and passive wrist motion exercises at home until 6 weeks post-op. From the 6-week timepoint onward, patients will have no restrictions. At the 6-week, 3 month, and 1 year postoperative visits, patients will have repeat radiographs taken, all measurements performed, and all questionnaires administered.

As stated, the follow-up visits for this study will be at 2 weeks, 6 weeks, 3 months, and 1 year. At each visit the patients will have radiographs taken, questionnaires administered, and quantitative testing done to assess range of motion and strength. Details further outlined below.

Conditions

Distal Radius Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early Mobilization

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

Group Type: ACTIVE_COMPARATOR

Early Mobilization Protocol

Intervention Type: PROCEDURE

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.

Late Mobilization

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

Group Type: ACTIVE_COMPARATOR

Late Mobilization Protocol

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brielle Orthopedics

UNKNOWN

Sponsor Role: collaborator

Universtiy Orthopedics Associates

UNKNOWN

Sponsor Role: collaborator

Robert Wood Johnson Barnabas Health

OTHER

Sponsor Role: lead

Responsible Party

Bobby Varghese, MD

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bobby Varghese, MD

Role: STUDY_DIRECTOR

Research Assistant

Locations

University Orthopedics Associates

Somerset, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Bobby Varghese, MD

Role: CONTACT

bv209@rwjms.rutgers.edu

8324657112

Facility Contacts

Bobby Varghese, MD

Role: primary

bv209@rwjms.rutgers.edu

832-465-7112

Todd Alter, MD

Role: backup

tha8@rutgers.edu

Other Identifiers

Mod2021000381

Identifier Type: -

Identifier Source: org_study_id