Early Mobilization Following Volar Locking Plate Fixation of Distal Radius Fractures

Patient Satisfaction With Early Wrist Mobilization Following Volar Locking Plate Fixation of Distal Radius Fractures - a Prospective Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Distal Radius Fracture
• Intervention / Treatment: Procedure: Early Mobilization Protocol; Procedure: Late Mobilization Protocol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bobby Varghese, MD; Phone Number: 8324657112; Email: bv209@rwjms.rutgers.edu

Study Locations

• United States
  • New Jersey
    • Somerset, New Jersey, United States, 08873
      • Recruiting
      • University Orthopedics Associates
      • Contact: Bobby Varghese, MD; Phone Number: 832-465-7112; Email: bv209@rwjms.rutgers.edu
      • Contact: Todd Alter, MD; Email: tha8@rutgers.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• Additional ipsilateral fracture (except ulnar styloid - this will be recorded, but not an exclusion criteria)
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Early Mobilization; Post-operatively subjects receive a removable wrist splint that can be taken off for early wrist mobilization	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.
Active Comparator: Late Mobilization; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic evaluation of volar tilt	volar tilt of the injured wrist will be measured using imaging processing software for radiographs.	2 weeks
Radiographic evaluation of volar tilt	volar tilt of the injured wrist will be measured using imaging processing software for radiographs.	6 weeks
Radiographic evaluation of volar tilt	volar tilt of the injured wrist will be measured using imaging processing software for radiographs.	3 Months
Radiographic evaluation of volar tilt	volar tilt of the injured wrist will be measured using imaging processing software for radiographs.	1 Year
Radiographic evaluation of radial inclination	Radial inclination of the injured wrist will be measured using imaging processing software for radiographs.	2 Weeks
Radiographic evaluation of radial inclination	Radial inclination of the injured wrist will be measured using imaging processing software for radiographs.	6 Weeks
Radiographic evaluation of radial inclination	Radial inclination of the injured wrist will be measured using imaging processing software for radiographs.	3 Months
Radiographic evaluation of radial inclination	Radial inclination of the injured wrist will be measured using imaging processing software for radiographs.	1 Year
Radiographic evaluation of radial height	Radial height of the injured wrist will be measured using imaging processing software for radiographs.	2 Weeks
Radiographic evaluation of radial height	Radial height of the injured wrist will be measured using imaging processing software for radiographs.	6 Weeks
Radiographic evaluation of radial height	Radial height of the injured wrist will be measured using imaging processing software for radiographs.	3 Months
Radiographic evaluation of radial height	Radial height of the injured wrist will be measured using imaging processing software for radiographs.	1 Year
Radiographic evaluation of ulnar variance	Ulnar variance of the injured wrist will be measured using imaging processing software for radiographs.	2 Weeks
Radiographic evaluation of ulnar variance	Ulnar variance of the injured wrist will be measured using imaging processing software for radiographs.	6 Weeks
Radiographic evaluation of ulnar variance	Ulnar variance of the injured wrist will be measured using imaging processing software for radiographs.	3 Months
Radiographic evaluation of ulnar variance	Ulnar variance of the injured wrist will be measured using imaging processing software for radiographs.	1 Year
Radiographic evaluation of articular step off	Articular step off of the injured wrist will be measured using imaging processing software for radiographs.	2 Weeks
Radiographic evaluation of articular step off	Articular step off of the injured wrist will be measured using imaging processing software for radiographs.	6 Weeks
Radiographic evaluation of articular step off	Articular step off of the injured wrist will be measured using imaging processing software for radiographs.	3 Months
Radiographic evaluation of articular step off	Articular step off of the injured wrist will be measured using imaging processing software for radiographs.	1 Year
Radiographic evaluation of healing	Fracture healing of the injured wrist will be measured using imaging processing software for radiographs.	2 Weeks
Radiographic evaluation of healing	Fracture healing of the injured wrist will be measured using imaging processing software for radiographs.	6 Weeks
Radiographic evaluation of healing	Fracture healing of the injured wrist will be measured using imaging processing software for radiographs.	3 Months
Radiographic evaluation of healing	Fracture healing of the injured wrist will be measured using imaging processing software for radiographs.	1 year
Radiographic evaluation of fractured ulnar styloid	Fracturing of the ulna styloid of the injured wrist will be evaluated using imaging processing software for radiographs.	2 Weeks
Radiographic evaluation of fractured ulnar styloid	Fracturing of the ulna styloid of the injured wrist will be evaluated using imaging processing software for radiographs.	6 Weeks
Radiographic evaluation of fractured ulnar styloid	Fracturing of the ulna styloid of the injured wrist will be evaluated using imaging processing software for radiographs.	3 Months
Radiographic evaluation of fractured ulnar styloid	Fracturing of the ulna styloid of the injured wrist will be evaluated using imaging processing software for radiographs.	1 Year
Radiographic evaluation of fractured scapholunate interval	Widening of the scapholunate interval of the injured wrist will be evaluated using imaging processing software for radiographs.	2 Weeks
Radiographic evaluation of fractured scapholunate interval	Widening of the scapholunate interval of the injured wrist will be evaluated using imaging processing software for radiographs.	6 Weeks
Radiographic evaluation of fractured scapholunate interval	Widening of the scapholunate interval of the injured wrist will be evaluated using imaging processing software for radiographs.	3 Months
Radiographic evaluation of fractured scapholunate interval	Widening of the scapholunate interval of the injured wrist will be evaluated using imaging processing software for radiographs.	1 Year
Visual Analog Scale for Pain Level (VAS)	Pain is described using a VAS that ranges from 0 to 10 where 0 is no pain and 10 is the worst pain.	2 Weeks
Visual Analog Scale for Pain Level (VAS)	Pain is described using a VAS that ranges from 0 to 10 where 0 is no pain and 10 is the worst pain.	6 Weeks
Visual Analog Scale for Pain Level (VAS)	Pain is described using a VAS that ranges from 0 to 10 where 0 is no pain and 10 is the worst pain.	3 Months
Visual Analog Scale for Pain Level (VAS)	Pain is described using a VAS that ranges from 0 to 10 where 0 is no pain and 10 is the worst pain.	1 Year
pain medication use	Records if subject is still using pain medication.	2 weeks
pain medication use	Records if subject is still using pain medication.	6 weeks
pain medication use	Records if subject is still using pain medication.	3 months
pain medication use	Records if subject is still using pain medication.	1 year
length of sick leave from work	Records the date of return to work if subject has returned to work	6 weeks
length of sick leave from work	Records the date of return to work if subject has returned to work	3 months
length of sick leave from work	Records the date of return to work if subject has returned to work	1 year
complications	hardware loosening, malunion, non-union, delayed union, hardware failure, loss of reduction, refracture, nerve palsy, weakness, paresthesia, neuropathy, tendon rupture, adhesion, infection, wound dehiscence	2 weeks
complications	hardware loosening, malunion, non-union, delayed union, hardware failure, loss of reduction, refracture, nerve palsy, weakness, paresthesia, neuropathy, tendon rupture, adhesion, infection, wound dehiscence	6 weeks
complications	hardware loosening, malunion, non-union, delayed union, hardware failure, loss of reduction, refracture, nerve palsy, weakness, paresthesia, neuropathy, tendon rupture, adhesion, infection, wound dehiscence	3 months
complications	hardware loosening, malunion, non-union, delayed union, hardware failure, loss of reduction, refracture, nerve palsy, weakness, paresthesia, neuropathy, tendon rupture, adhesion, infection, wound dehiscence	1 year
Surgical Satisfaction Questionnaire (SSQ-8)	A series of questions answered using a Likert Scale from 0 - "Very Unsatisfied" to 4 - "Very Satisfied." The score ranges from 0 - 100 with higher scores indicating higher satisfaction.	6 weeks
Surgical Satisfaction Questionnaire (SSQ-8)	A series of questions answered using a Likert Scale from 0 - "Very Unsatisfied" to 4 - "Very Satisfied." The score ranges from 0 - 100 with higher scores indicating higher satisfaction.	3 months
Surgical Satisfaction Questionnaire (SSQ-8)	A series of questions answered using a Likert Scale from 0 - "Very Unsatisfied" to 4 - "Very Satisfied." The score ranges from 0 - 100 with higher scores indicating higher satisfaction.	1 year

Collaborators and Investigators

• Sponsor: Robert Wood Johnson Barnabas Health
• Collaborators: Brielle Orthopedics; Universtiy Orthopedics Associates
• Investigators: Study Director: Bobby Varghese, MD, Research assistant

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2021
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: August 27, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: August 27, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: wrist fracture; volar locking plate; plates and screws
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: Mod2021000381

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No