Clinical trial NCT05033938: Early Mobilization Following Volar Locking Plate Fixation of Distal Radius Fractures
Official title: Patient Satisfaction With Early Wrist Mobilization Following Volar Locking Plate Fixation of Distal Radius Fractures - a Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Distal Radius Fracture
Keywords: volar locking plate
wrist fracture
plates and screws
Lead sponsor: Robert Wood Johnson Barnabas Health
Sponsor class: OTHER
Collaborators: name: Brielle Orthopedics
name: Universtiy Orthopedics Associates
First posted: 2021-09-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Non-operative Hand Active Wrist Flexion
timeFrame: 6 weeks
measure: Non-operative Hand Active Wrist Flexion
timeFrame: 3 months
measure: Non-operative Hand Active Wrist Flexion
timeFrame: 1 year
measure: Non-operative Hand Passive Wrist Flexion
timeFrame: 6 weeks
measure: Non-operative Hand Passive Wrist Flexion
timeFrame: 3 Months
measure: Non-operative Hand Passive Wrist Flexion
timeFrame: 1 Year
measure: Non-operative Hand Active Wrist Extension
timeFrame: 6 weeks
measure: Non-operative Hand Active Wrist Extension
timeFrame: 3 Months
measure: Non-operative Hand Active Wrist Extension
timeFrame: 1 Year
measure: Non-operative Hand Passive Wrist Extension
timeFrame: 6 weeks
measure: Non-operative Hand Passive Wrist Extension
timeFrame: 3 Months
measure: Non-operative Hand Passive Wrist Extension
timeFrame: 1 Year
measure: Operative Hand Active Wrist Extension
timeFrame: 6 weeks
measure: Operative Hand Active Wrist Extension
timeFrame: 3 Months
measure: Operative Hand Active Wrist Extension
timeFrame: 1 Year
measure: Operative Hand Passive Wrist Extension
timeFrame: 6 weeks
measure: Operative Hand Passive Wrist Extension
timeFrame: 3 Months
measure: Operative Hand Passive Wrist Extension
timeFrame: 1 Year
measure: Operative Hand Active Wrist Flexion
timeFrame: 6 weeks
measure: Operative Hand Active Wrist Flexion
timeFrame: 3 Months
measure: Operative Hand Active Wrist Flexion
timeFrame: 1 Year
measure: Operative Hand Passive Wrist Flexion
timeFrame: 6 weeks
measure: Operative Hand Passive Wrist Flexion
timeFrame: 3 Months
measure: Operative Hand Passive Wrist Flexion
timeFrame: 1 Year
measure: Non-operative Hand Active Wrist Supination
timeFrame: 6 Weeks
measure: Non-operative Hand Active Wrist Supination
timeFrame: 3 Months
measure: Non-operative Hand Active Wrist Supination
timeFrame: 1 Year
measure: Non-operative Hand Passive Wrist Supination
timeFrame: 6 Weeks
measure: Non-operative Hand Passive Wrist Supination
timeFrame: 3 Months
measure: Non-operative Hand Passive Wrist Supination
timeFrame: 1 Year
measure: Operative Hand Active Wrist Supination
timeFrame: 6 Weeks
measure: Operative Hand Active Wrist Supination
timeFrame: 3 months
measure: Operative Hand Active Wrist Supination
timeFrame: 1 Year
measure: Operative Hand Passive Wrist Supination
timeFrame: 6 Weeks
measure: Operative Hand Passive Wrist Supination
timeFrame: 3 Months
measure: Operative Hand Passive Wrist Supination
timeFrame: 1 Year
Secondary outcomes:
measure: Radiographic evaluation of volar tilt
timeFrame: 2 weeks
measure: Radiographic evaluation of volar tilt
timeFrame: 6 weeks
measure: Radiographic evaluation of volar tilt
timeFrame: 3 Months
measure: Radiographic evaluation of volar tilt
timeFrame: 1 Year
measure: Radiographic evaluation of radial inclination
timeFrame: 2 Weeks
measure: Radiographic evaluation of radial inclination
timeFrame: 6 Weeks
measure: Radiographic evaluation of radial inclination
timeFrame: 3 Months
measure: Radiographic evaluation of radial inclination
timeFrame: 1 Year
measure: Radiographic evaluation of radial height
timeFrame: 2 Weeks
measure: Radiographic evaluation of radial height
timeFrame: 6 Weeks
measure: Radiographic evaluation of radial height
timeFrame: 3 Months
measure: Radiographic evaluation of radial height
timeFrame: 1 Year
measure: Radiographic evaluation of ulnar variance
timeFrame: 2 Weeks
measure: Radiographic evaluation of ulnar variance
timeFrame: 6 Weeks
measure: Radiographic evaluation of ulnar variance
timeFrame: 3 Months
measure: Radiographic evaluation of ulnar variance
timeFrame: 1 Year
measure: Radiographic evaluation of articular step off
timeFrame: 2 Weeks
measure: Radiographic evaluation of articular step off
timeFrame: 6 Weeks
measure: Radiographic evaluation of articular step off
timeFrame: 3 Months
measure: Radiographic evaluation of articular step off
timeFrame: 1 Year
measure: Radiographic evaluation of healing
timeFrame: 2 Weeks
measure: Radiographic evaluation of healing
timeFrame: 6 Weeks
measure: Radiographic evaluation of healing
timeFrame: 3 Months
measure: Radiographic evaluation of healing
timeFrame: 1 year
measure: Radiographic evaluation of fractured ulnar styloid
timeFrame: 2 Weeks
measure: Radiographic evaluation of fractured ulnar styloid
timeFrame: 6 Weeks
measure: Radiographic evaluation of fractured ulnar styloid
timeFrame: 3 Months
measure: Radiographic evaluation of fractured ulnar styloid
timeFrame: 1 Year
measure: Radiographic evaluation of fractured scapholunate interval
timeFrame: 2 Weeks
measure: Radiographic evaluation of fractured scapholunate interval
timeFrame: 6 Weeks
measure: Radiographic evaluation of fractured scapholunate interval
timeFrame: 3 Months
measure: Radiographic evaluation of fractured scapholunate interval
timeFrame: 1 Year
measure: Visual Analog Scale for Pain Level (VAS)
timeFrame: 2 Weeks
measure: Visual Analog Scale for Pain Level (VAS)
timeFrame: 6 Weeks
measure: Visual Analog Scale for Pain Level (VAS)
timeFrame: 3 Months
measure: Visual Analog Scale for Pain Level (VAS)
timeFrame: 1 Year
measure: pain medication use
timeFrame: 2 weeks
measure: pain medication use
timeFrame: 6 weeks
measure: pain medication use
timeFrame: 3 months
measure: pain medication use
timeFrame: 1 year
measure: length of sick leave from work
timeFrame: 6 weeks
measure: length of sick leave from work
timeFrame: 3 months
measure: length of sick leave from work
timeFrame: 1 year
measure: complications
timeFrame: 2 weeks
measure: complications
timeFrame: 6 weeks
measure: complications
timeFrame: 3 months
measure: complications
timeFrame: 1 year
measure: Surgical Satisfaction Questionnaire (SSQ-8)
timeFrame: 6 weeks
measure: Surgical Satisfaction Questionnaire (SSQ-8)
timeFrame: 3 months
measure: Surgical Satisfaction Questionnaire (SSQ-8)
timeFrame: 1 year
Other outcomes:
Locations:
city: Somerset
country: United States
facility: University Orthopedics Associates
state: New Jersey
Study officials:
affiliation: Research Assistant
name: Bobby Varghese, MD
role: STUDY_DIRECTOR
References: