Patient Satisfaction With Early Wrist Mobilization Following Volar Locking Plate Fixation of Distal Radius Fractures - a Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Non-operative Hand Active Wrist Flexion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Early Mobilization
Post-operatively subjects receive a removable wrist splint that can be taken off for early wrist mobilization
干预措施: Early Mobilization Protocol (Procedure)
Late Mobilization
Post-operatively subjects receive a splint and are not instructed to not move their wrist till the 2 week follow up visit.
干预措施: Late Mobilization Protocol (Procedure)
结局指标
主要结局
Non-operative Hand Active Wrist Flexion
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
Non-operative Hand Active Wrist Flexion
时间窗: 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
时间窗: 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 Passive Wrist Flexion
时间窗: 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
时间窗: 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 Active Wrist Extension
时间窗: 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
时间窗: 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 Passive Wrist Extension
时间窗: 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
时间窗: 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
Operative Hand Active Wrist Extension
时间窗: 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
时间窗: 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 Passive Wrist Extension
时间窗: 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
时间窗: 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 Active Wrist Flexion
时间窗: 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
时间窗: 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 Passive Wrist Flexion
时间窗: 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
时间窗: 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
Non-operative Hand Active Wrist Supination
时间窗: 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
时间窗: 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 Passive Wrist Supination
时间窗: 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
时间窗: 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
Operative Hand Active Wrist Supination
时间窗: 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
时间窗: 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 Passive Wrist Supination
时间窗: 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
时间窗: 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
次要结局
- Radiographic evaluation of radial inclination(1 Year)
- Radiographic evaluation of volar tilt(1 Year)
- Radiographic evaluation of radial height(1 Year)
- Radiographic evaluation of ulnar variance(1 Year)
- Radiographic evaluation of articular step off(1 Year)
- Radiographic evaluation of healing(1 year)
- Radiographic evaluation of fractured ulnar styloid(1 Year)
- Radiographic evaluation of fractured scapholunate interval(1 Year)
- Visual Analog Scale for Pain Level (VAS)(1 Year)
- pain medication use(1 year)
- length of sick leave from work(1 year)
- complications(1 year)
- Surgical Satisfaction Questionnaire (SSQ-8)(1 year)
- Radiographic evaluation of volar tilt(2 weeks)
- Radiographic evaluation of volar tilt(6 weeks)
- Radiographic evaluation of volar tilt(3 Months)
- Radiographic evaluation of radial inclination(2 Weeks)
- Radiographic evaluation of radial inclination(6 Weeks)
- Radiographic evaluation of radial inclination(3 Months)
- Radiographic evaluation of radial height(2 Weeks)
- Radiographic evaluation of radial height(6 Weeks)
- Radiographic evaluation of radial height(3 Months)
- Radiographic evaluation of ulnar variance(2 Weeks)
- Radiographic evaluation of ulnar variance(6 Weeks)
- Radiographic evaluation of ulnar variance(3 Months)
- Radiographic evaluation of articular step off(2 Weeks)
- Radiographic evaluation of articular step off(6 Weeks)
- Radiographic evaluation of articular step off(3 Months)
- Radiographic evaluation of healing(2 Weeks)
- Radiographic evaluation of healing(6 Weeks)
- Radiographic evaluation of healing(3 Months)
- Radiographic evaluation of fractured ulnar styloid(2 Weeks)
- Radiographic evaluation of fractured ulnar styloid(6 Weeks)
- Radiographic evaluation of fractured ulnar styloid(3 Months)
- Radiographic evaluation of fractured scapholunate interval(2 Weeks)
- Radiographic evaluation of fractured scapholunate interval(6 Weeks)
- Radiographic evaluation of fractured scapholunate interval(3 Months)
- Visual Analog Scale for Pain Level (VAS)(2 Weeks)
- Visual Analog Scale for Pain Level (VAS)(6 Weeks)
- Visual Analog Scale for Pain Level (VAS)(3 Months)
- pain medication use(2 weeks)
- pain medication use(6 weeks)
- pain medication use(3 months)
- length of sick leave from work(6 weeks)
- length of sick leave from work(3 months)
- complications(2 weeks)
- complications(6 weeks)
- complications(3 months)
- Surgical Satisfaction Questionnaire (SSQ-8)(6 weeks)
- Surgical Satisfaction Questionnaire (SSQ-8)(3 months)
研究者
Bobby Varghese, MD
Research Assistant
Robert Wood Johnson Barnabas Health