Postoperative Immobilization and Physical Therapy Following Volar Locked Plating for Distal Radius Fractures: Are They Necessary?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- NYU Langone Health
- Enrollment
- 230
- Locations
- 1
- Primary Endpoint
- Percentage of Loss of fixation
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Delayed mobilization/Formal physical therapy group
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.
Intervention: Splint (Other)
Delayed mobilization/Formal physical therapy group
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.
Intervention: Formal Physical Therapy (Behavioral)
Immediate mobilization/self guided physical therapy group
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.
Intervention: Self directed physical therapy (Behavioral)
Immediate mobilization/self guided physical therapy group
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.
Intervention: Soft dressing (No Splint) (Other)
Outcomes
Primary Outcomes
Percentage of Loss of fixation
Time Frame: 2 weeks, 4 weeks, 12 weeks, 24 weeks
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.
Secondary Outcomes
- Change in wrist range mobility using DASH(2 weeks, 4 weeks, 12 weeks, 24 weeks)
- Change in Patient comfort/pain (VAS)(Day of Surgery, 2 weeks, 4 weeks, 12 weeks, 24 weeks)
- Change in wrist range mobility(2 weeks, 4 weeks, 12 weeks, 24 weeks)
- Change in Grip strength(2 weeks, 4 weeks, 12 weeks, 24 weeks)