Early Mobilization Following Volar Locking Plate Fixation of Distal Radius Fractures

Distal Radius Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05033938
• Other study ID #: Mod2021000381
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2021
• Est. completion date: April 1, 2023

Study information

• Verified date: August 2021
• Source: Robert Wood Johnson Barnabas Health
• Contact: Bobby Varghese, MD
• Phone: 8324657112
• Email: bv209[@]rwjms.rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	University Orthopedics Associates	Somerset	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Robert Wood Johnson Barnabas Health	Brielle Orthopedics, Universtiy Orthopedics Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Radiographic evaluation of volar tilt	volar tilt of the injured wrist will be measured using imaging processing software for radiographs.	2 weeks
Secondary	Radiographic evaluation of volar tilt	volar tilt of the injured wrist will be measured using imaging processing software for radiographs.	6 weeks
Secondary	Radiographic evaluation of volar tilt	volar tilt of the injured wrist will be measured using imaging processing software for radiographs.	3 Months
Secondary	Radiographic evaluation of volar tilt	volar tilt of the injured wrist will be measured using imaging processing software for radiographs.	1 Year
Secondary	Radiographic evaluation of radial inclination	Radial inclination of the injured wrist will be measured using imaging processing software for radiographs.	2 Weeks
Secondary	Radiographic evaluation of radial inclination	Radial inclination of the injured wrist will be measured using imaging processing software for radiographs.	6 Weeks
Secondary	Radiographic evaluation of radial inclination	Radial inclination of the injured wrist will be measured using imaging processing software for radiographs.	3 Months
Secondary	Radiographic evaluation of radial inclination	Radial inclination of the injured wrist will be measured using imaging processing software for radiographs.	1 Year
Secondary	Radiographic evaluation of radial height	Radial height of the injured wrist will be measured using imaging processing software for radiographs.	2 Weeks
Secondary	Radiographic evaluation of radial height	Radial height of the injured wrist will be measured using imaging processing software for radiographs.	6 Weeks
Secondary	Radiographic evaluation of radial height	Radial height of the injured wrist will be measured using imaging processing software for radiographs.	3 Months
Secondary	Radiographic evaluation of radial height	Radial height of the injured wrist will be measured using imaging processing software for radiographs.	1 Year
Secondary	Radiographic evaluation of ulnar variance	Ulnar variance of the injured wrist will be measured using imaging processing software for radiographs.	2 Weeks
Secondary	Radiographic evaluation of ulnar variance	Ulnar variance of the injured wrist will be measured using imaging processing software for radiographs.	6 Weeks
Secondary	Radiographic evaluation of ulnar variance	Ulnar variance of the injured wrist will be measured using imaging processing software for radiographs.	3 Months
Secondary	Radiographic evaluation of ulnar variance	Ulnar variance of the injured wrist will be measured using imaging processing software for radiographs.	1 Year
Secondary	Radiographic evaluation of articular step off	Articular step off of the injured wrist will be measured using imaging processing software for radiographs.	2 Weeks
Secondary	Radiographic evaluation of articular step off	Articular step off of the injured wrist will be measured using imaging processing software for radiographs.	6 Weeks
Secondary	Radiographic evaluation of articular step off	Articular step off of the injured wrist will be measured using imaging processing software for radiographs.	3 Months
Secondary	Radiographic evaluation of articular step off	Articular step off of the injured wrist will be measured using imaging processing software for radiographs.	1 Year
Secondary	Radiographic evaluation of healing	Fracture healing of the injured wrist will be measured using imaging processing software for radiographs.	2 Weeks
Secondary	Radiographic evaluation of healing	Fracture healing of the injured wrist will be measured using imaging processing software for radiographs.	6 Weeks
Secondary	Radiographic evaluation of healing	Fracture healing of the injured wrist will be measured using imaging processing software for radiographs.	3 Months
Secondary	Radiographic evaluation of healing	Fracture healing of the injured wrist will be measured using imaging processing software for radiographs.	1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	pain medication use	Records if subject is still using pain medication.	2 weeks
Secondary	pain medication use	Records if subject is still using pain medication.	6 weeks
Secondary	pain medication use	Records if subject is still using pain medication.	3 months
Secondary	pain medication use	Records if subject is still using pain medication.	1 year
Secondary	length of sick leave from work	Records the date of return to work if subject has returned to work	6 weeks
Secondary	length of sick leave from work	Records the date of return to work if subject has returned to work	3 months
Secondary	length of sick leave from work	Records the date of return to work if subject has returned to work	1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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