Distal Radius FractureNCT05033938
Early Mobilization Following Volar Locking Plate Fixation of Distal Radius Fractures
A study testing Early Mobilization Protocol and Late Mobilization Protocol in people with Distal Radius Fracture, run by Robert Wood Johnson Barnabas Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Early Mobilization Protocol and Late Mobilization Protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2021to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University Orthopedics Associates
Somerset, New Jersey, 08873
Bobby Varghese, MD, 832-465-7112, bv209@rwjms.rutgers.edu
Todd Alter, MD, tha8@rutgers.edu
About this study
Official title: 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.
Read the 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
- Being tested
- Early Mobilization Protocol, Late Mobilization Protocol
- Keywords
- volar locking plate, wrist fracture, plates and screws
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Mobilization ProtocolProcedure or surgery
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 ProtocolProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Early Mobilization | Active comparator | Post-operatively subjects receive a removable wrist splint that can be taken off for early wrist mobilization Receives: 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. Receives: Procedure: Late Mobilization Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 Year
Secondary outcomes (50)
Radiographic evaluation of volar tilt
volar tilt of the injured wrist will be measured using imaging processing software for radiographs.
Measured: 2 weeks
Radiographic evaluation of volar tilt
volar tilt of the injured wrist will be measured using imaging processing software for radiographs.
Measured: 6 weeks
Radiographic evaluation of volar tilt
volar tilt of the injured wrist will be measured using imaging processing software for radiographs.
Measured: 3 Months
Radiographic evaluation of volar tilt
volar tilt of the injured wrist will be measured using imaging processing software for radiographs.
Measured: 1 Year
Radiographic evaluation of radial inclination
Radial inclination of the injured wrist will be measured using imaging processing software for radiographs.
Measured: 2 Weeks
Radiographic evaluation of radial inclination
Radial inclination of the injured wrist will be measured using imaging processing software for radiographs.
Measured: 6 Weeks
Radiographic evaluation of radial inclination
Radial inclination of the injured wrist will be measured using imaging processing software for radiographs.
Measured: 3 Months
Radiographic evaluation of radial inclination
Radial inclination of the injured wrist will be measured using imaging processing software for radiographs.
Measured: 1 Year
Radiographic evaluation of radial height
Radial height of the injured wrist will be measured using imaging processing software for radiographs.
Measured: 2 Weeks
Radiographic evaluation of radial height
Radial height of the injured wrist will be measured using imaging processing software for radiographs.
Measured: 6 Weeks
Radiographic evaluation of radial height
Radial height of the injured wrist will be measured using imaging processing software for radiographs.
Measured: 3 Months
Radiographic evaluation of radial height
Radial height of the injured wrist will be measured using imaging processing software for radiographs.
Measured: 1 Year
Radiographic evaluation of ulnar variance
Ulnar variance of the injured wrist will be measured using imaging processing software for radiographs.
Measured: 2 Weeks
Radiographic evaluation of ulnar variance
Ulnar variance of the injured wrist will be measured using imaging processing software for radiographs.
Measured: 6 Weeks
Radiographic evaluation of ulnar variance
Ulnar variance of the injured wrist will be measured using imaging processing software for radiographs.
Measured: 3 Months
Radiographic evaluation of ulnar variance
Ulnar variance of the injured wrist will be measured using imaging processing software for radiographs.
Measured: 1 Year
Radiographic evaluation of articular step off
Articular step off of the injured wrist will be measured using imaging processing software for radiographs.
Measured: 2 Weeks
Radiographic evaluation of articular step off
Articular step off of the injured wrist will be measured using imaging processing software for radiographs.
Measured: 6 Weeks
Radiographic evaluation of articular step off
Articular step off of the injured wrist will be measured using imaging processing software for radiographs.
Measured: 3 Months
Radiographic evaluation of articular step off
Articular step off of the injured wrist will be measured using imaging processing software for radiographs.
Measured: 1 Year
Radiographic evaluation of healing
Fracture healing of the injured wrist will be measured using imaging processing software for radiographs.
Measured: 2 Weeks
Radiographic evaluation of healing
Fracture healing of the injured wrist will be measured using imaging processing software for radiographs.
Measured: 6 Weeks
Radiographic evaluation of healing
Fracture healing of the injured wrist will be measured using imaging processing software for radiographs.
Measured: 3 Months
Radiographic evaluation of healing
Fracture healing of the injured wrist will be measured using imaging processing software for radiographs.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 Year
pain medication use
Records if subject is still using pain medication.
Measured: 2 weeks
pain medication use
Records if subject is still using pain medication.
Measured: 6 weeks
pain medication use
Records if subject is still using pain medication.
Measured: 3 months
pain medication use
Records if subject is still using pain medication.
Measured: 1 year
length of sick leave from work
Records the date of return to work if subject has returned to work
Measured: 6 weeks
length of sick leave from work
Records the date of return to work if subject has returned to work
Measured: 3 months
length of sick leave from work
Records the date of return to work if subject has returned to work
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start5 Apr 2021
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Wood Johnson Barnabas Health
- Sponsor type
- University, hospital or other
- Collaborators
- Brielle Orthopedics, Universtiy Orthopedics Associates
- Responsible party
- Principal investigator, Bobby Varghese, MD, Robert Wood Johnson Barnabas Health
- Investigators
- Bobby Varghese, MD, Study director, Research Assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033938
- Sponsor's protocol ID
- Mod2021000381
- Status last verified
- Aug 2021
- First submitted
- 22 Jul 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction With Early Wrist Mobilization Following Volar Locking Plate Fixation of Distal Radius Fractures - a Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05033938
- Acronym / sponsor ID
- Mod2021000381
- Conditions
- Distal Radius Fracture
- Keywords
- volar locking plate, wrist fracture, plates and screws
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Robert Wood Johnson Barnabas HealthUniversity, hospital or other
- Collaborators
- Brielle Orthopedics, Universtiy Orthopedics Associates
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Mobilization | Active comparator | Procedure: Early Mobilization ProtocolPost-operatively subjects receive a removable wrist splint that can be taken off for early wrist mobilization |
| Late Mobilization | Active comparator | Procedure: Late Mobilization ProtocolPost-operatively subjects receive a splint and are not instructed to not move their wrist till the 2 week follow up visit. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- Open fractures
- Comminuted fractures
- Polytrauma
- Bilateral DRFs
- Previous contralateral wrist injury that could limit comparison
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Mobilization ProtocolSubjects 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. | Procedure or surgery | Early Mobilization |
| Late Mobilization ProtocolSubjects 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 | Procedure or surgery | Late Mobilization |
Primary outcome
Non-operative Hand Active Wrist Flexion
Time frame: 6 weeks
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
Non-operative Hand Active Wrist Flexion
Time frame: 3 months
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
Non-operative Hand Active Wrist Flexion
Time frame: 1 year
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
Non-operative Hand Passive Wrist Flexion
Time frame: 6 weeks
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
Non-operative Hand Passive Wrist Flexion
Time frame: 3 Months
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
Non-operative Hand Passive Wrist Flexion
Time frame: 1 Year
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
Non-operative Hand Active Wrist Extension
Time frame: 6 weeks
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
Non-operative Hand Active Wrist Extension
Time frame: 3 Months
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
Non-operative Hand Active Wrist Extension
Time frame: 1 Year
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
Non-operative Hand Passive Wrist Extension
Time frame: 6 weeks
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
Non-operative Hand Passive Wrist Extension
Time frame: 3 Months
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
Non-operative Hand Passive Wrist Extension
Time frame: 1 Year
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
Operative Hand Active Wrist Extension
Time frame: 6 weeks
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
Operative Hand Active Wrist Extension
Time frame: 3 Months
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
Operative Hand Active Wrist Extension
Time frame: 1 Year
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
Operative Hand Passive Wrist Extension
Time frame: 6 weeks
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
Operative Hand Passive Wrist Extension
Time frame: 3 Months
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
Operative Hand Passive Wrist Extension
Time frame: 1 Year
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
Operative Hand Active Wrist Flexion
Time frame: 6 weeks
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
Operative Hand Active Wrist Flexion
Time frame: 3 Months
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
Operative Hand Active Wrist Flexion
Time frame: 1 Year
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
Operative Hand Passive Wrist Flexion
Time frame: 6 weeks
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
Operative Hand Passive Wrist Flexion
Time frame: 3 Months
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
Operative Hand Passive Wrist Flexion
Time frame: 1 Year
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
Non-operative Hand Active Wrist Supination
Time frame: 6 Weeks
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
Non-operative Hand Active Wrist Supination
Time frame: 3 Months
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
Non-operative Hand Active Wrist Supination
Time frame: 1 Year
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
Non-operative Hand Passive Wrist Supination
Time frame: 6 Weeks
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
Non-operative Hand Passive Wrist Supination
Time frame: 3 Months
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
Non-operative Hand Passive Wrist Supination
Time frame: 1 Year
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
Operative Hand Active Wrist Supination
Time frame: 6 Weeks
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
Operative Hand Active Wrist Supination
Time frame: 3 months
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
Operative Hand Active Wrist Supination
Time frame: 1 Year
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
Operative Hand Passive Wrist Supination
Time frame: 6 Weeks
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
Operative Hand Passive Wrist Supination
Time frame: 3 Months
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
Operative Hand Passive Wrist Supination
Time frame: 1 Year
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
50 secondary outcomes
Radiographic evaluation of volar tilt
Time frame: 2 weeks
Radiographic evaluation of volar tilt
Time frame: 6 weeks
Radiographic evaluation of volar tilt
Time frame: 3 Months
Radiographic evaluation of volar tilt
Time frame: 1 Year
Radiographic evaluation of radial inclination
Time frame: 2 Weeks
Radiographic evaluation of radial inclination
Time frame: 6 Weeks
Radiographic evaluation of radial inclination
Time frame: 3 Months
Radiographic evaluation of radial inclination
Time frame: 1 Year
Radiographic evaluation of radial height
Time frame: 2 Weeks
Radiographic evaluation of radial height
Time frame: 6 Weeks
Radiographic evaluation of radial height
Time frame: 3 Months
Radiographic evaluation of radial height
Time frame: 1 Year
Radiographic evaluation of ulnar variance
Time frame: 2 Weeks
Radiographic evaluation of ulnar variance
Time frame: 6 Weeks
Radiographic evaluation of ulnar variance
Time frame: 3 Months
Radiographic evaluation of ulnar variance
Time frame: 1 Year
Radiographic evaluation of articular step off
Time frame: 2 Weeks
Radiographic evaluation of articular step off
Time frame: 6 Weeks
Radiographic evaluation of articular step off
Time frame: 3 Months
Radiographic evaluation of articular step off
Time frame: 1 Year
Radiographic evaluation of healing
Time frame: 2 Weeks
Radiographic evaluation of healing
Time frame: 6 Weeks
Radiographic evaluation of healing
Time frame: 3 Months
Radiographic evaluation of healing
Time frame: 1 year
Radiographic evaluation of fractured ulnar styloid
Time frame: 2 Weeks
Radiographic evaluation of fractured ulnar styloid
Time frame: 6 Weeks
Radiographic evaluation of fractured ulnar styloid
Time frame: 3 Months
Radiographic evaluation of fractured ulnar styloid
Time frame: 1 Year
Radiographic evaluation of fractured scapholunate interval
Time frame: 2 Weeks
Radiographic evaluation of fractured scapholunate interval
Time frame: 6 Weeks
Radiographic evaluation of fractured scapholunate interval
Time frame: 3 Months
Radiographic evaluation of fractured scapholunate interval
Time frame: 1 Year
Visual Analog Scale for Pain Level (VAS)
Time frame: 2 Weeks
Visual Analog Scale for Pain Level (VAS)
Time frame: 6 Weeks
Visual Analog Scale for Pain Level (VAS)
Time frame: 3 Months
Visual Analog Scale for Pain Level (VAS)
Time frame: 1 Year
pain medication use
Time frame: 2 weeks
pain medication use
Time frame: 6 weeks
pain medication use
Time frame: 3 months
pain medication use
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bobby Varghese, MD study director
Research Assistant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Mobilization Protocol and Late Mobilization Protocol in people with Distal Radius Fracture, run by Robert Wood Johnson Barnabas Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bobby Varghese, MD (8324657112, bv209@rwjms.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-operative Hand Active Wrist Flexion (time frame: 6 weeks). The study lists 36 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.