Postoperative Immobilization and Physical Therapy Following Volar Locked Plating for Distal Radius Fractures

Study Overview
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Brief Summary
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The purpose of this study is to see if splinting and formal physical therapy are necessary following surgical fixation (open reduction internal fixation) of distal radius fractures (broken wrist). Currently there is no consensus for post-operative protocol following fixation of distal radius fractures. The decision to splint (late mobilization) and prescribe formal physical therapy vs. not to splint (early mobilization) and use self-guided physical therapy is based on surgeon or institutional preference. The goal of this study is to determine if early mobilization leads to improved outcomes and decreased costs without increasing pain or the loss of hardware fixation.

Detailed Description
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188 patients treated for distal radius fractures with open reduction internal fixation using volar locked plating will be split into two study groups: a group that is immobilized in a splint post operatively and given formal physical therapy and a group that does not receive either of these post operative interventions. The primary outcome will be loss of fixation. Secondary outcomes will include pain, cost, Quick Dash, range of motion, and grip strength. Data will be recorded at the pre-operative visit, as well as at post-operative visits at 2 weeks, 6 weeks, 3 months and 6 months.

Official Title
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Postoperative Immobilization and Physical Therapy Following Volar Locked Plating for Distal Radius Fractures: Are They Necessary?

Conditions
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Distal Radius Fracture

Intervention / Treatment
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* Other: Splint
* Behavioral: Formal Physical Therapy
* Behavioral: Self directed physical therapy
* Other: Soft dressing (No Splint)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Isolated displaced distal radius fractures, +/- ulnar styloid fracture, treated with volar locked plating and screws. > 10 degrees of dorsal tilt Volar displacement (Volar Barton's type fracture) Shortening > 3 mm Intra-articular displacement or step off > 2mm. Exclusion Criteria: Ipsilateral upper limb concomitant fracture Fracture fixation other than volar locked plating and screws Dislocation or neurologic injury Gustilo-Anderson grade III open fractures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Delayed mobilization/Formal physical therapy group<br>Participants will be placed into a volar-based plaster splint post-operatively. Participants will be asked to keep non-weight bearing (on the operated wrist) but no restrictions for range of motion, keeping the dressing in place until first post-operative visit at 2 weeks. After that, participants will be placed into a custom thermoplastic splint by a therapist. This will be worn for 5 weeks. Supervised physical therapy will be prescribed 1- 2 times per week for a total of 8 weeks along with a home exercise program. Active range of motion and strengthening exercises will be performed at home twice daily for 20 minutes for a total of 8 weeks. The splint will be removed only for formal and home physical therapy and hygiene. | Other: Splint<br>* Participants will have their open reduction internal fixation of distal radius fractures treated with volar locked plating. for 2 weeks. Which will be replaced by a custom thermoplastic splint for 5 weeks.<br>Behavioral: Formal Physical Therapy<br>* Participants will also receive a prescription for formal physical therapy. Supervised physical therapy will be prescribed 1- 2 times per week for a total of 8 weeks along with a home exercise program. Active range of motion and strengthening exercises will be performed at home twice daily for 20 minutes for a total of 8 weeks.<br>|
| Active Comparator: Immediate mobilization/self guided physical therapy group<br>Participants will be placed into a soft dressing after surgery. Participants will be asked to keep non-weight bearing (on the operated wrist) but no restrictions for range of motion, keeping the dressing in place until first post-operative visit at 2 weeks. This group will be given a pamphlet with detailed instructions and demonstrations in home exercises. Active range of motion and strengthening exercises will be performed twice daily for 20 minutes for a total of 8 weeks. | Behavioral: Self directed physical therapy<br>* Participants will be given a pamphlet with detailed instructions and demonstrations in home exercises. Active range of motion and strengthening exercises will be performed twice daily for 20 minutes for a total of 8 weeks.<br>Other: Soft dressing (No Splint)<br>* Participants will have their open reduction internal fixation of distal radius fractures placed in a soft dressing which will be kept in place for 2 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Loss of fixation | The loss of fixation will be measured by the change in radiologic outcomes (in degrees) from 2-week post-operative visit to follow-up visits. | 2 weeks, 4 weeks, 12 weeks, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient comfort/pain (VAS) | This will be measured by the Visual Analogue Scale (VAS) which measures pain using a 10 point scale. On a scale of 1-10 where following pain scale is: no pain (0), mild pain(1-3), moderate pain (4-6), and severe pain (7-10). | Day of Surgery, 2 weeks, 4 weeks, 12 weeks, 24 weeks | 
| Change in wrist range mobility | Range of motion will be measured using goniometers. | 2 weeks, 4 weeks, 12 weeks, 24 weeks | 
| Change in wrist range mobility using DASH | This is measured using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. | 2 weeks, 4 weeks, 12 weeks, 24 weeks | 
| Change in Grip strength | Physical examinations through the study will record the grip strength (kgs) | 2 weeks, 4 weeks, 12 weeks, 24 weeks |