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

Not Applicable

Recruiting

• Conditions: Distal Radius Fracture
• Interventions: Other: Splint; Behavioral: Self directed physical therapy; Other: Soft dressing (No Splint); Behavioral: Formal Physical Therapy

• Registration Number: NCT04324580
• Lead Sponsor: NYU Langone Health

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-25
• Study First Posted: 2020-03-27
• Study Start: 2020-06-18
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2024-09-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Isolated displaced distal radius fractures, +/- ulnar styloid fracture, treated with volar locked plating and screws.

  1. > 10 degrees of dorsal tilt
  2. Volar displacement (Volar Barton's type fracture)
  3. Shortening > 3 mm
  4. Intra-articular displacement or step off > 2mm.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate mobilization/self guided physical therapy group	Soft dressing (No Splint)	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.
Delayed mobilization/Formal physical therapy group	Splint	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.
Delayed mobilization/Formal physical therapy group	Formal Physical Therapy	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.
Immediate mobilization/self guided physical therapy group	Self directed physical therapy	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Loss of fixation	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 Outcome Measures

Name	Time	Method
Change in wrist range mobility using DASH	2 weeks, 4 weeks, 12 weeks, 24 weeks	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.
Change in Patient comfort/pain (VAS)	Day of Surgery, 2 weeks, 4 weeks, 12 weeks, 24 weeks	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).
Change in wrist range mobility	2 weeks, 4 weeks, 12 weeks, 24 weeks	Range of motion will be measured using goniometers.
Change in Grip strength	2 weeks, 4 weeks, 12 weeks, 24 weeks	Physical examinations through the study will record the grip strength (kgs)

Trial Locations

Locations (1)

NYU Langone; 🇺🇸 New York, New York, United States