NCT04324580

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Distal Radius Fracture

Interventions

Type	Name	Description
OTHER	Splint	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.
BEHAVIORAL	Formal Physical Therapy	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.
BEHAVIORAL	Self directed physical therapy	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.
OTHER	Soft dressing (No Splint)	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.

Timeline

• Start date: 2020-06-18
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2020-03-27
• Last updated: 2026-04-01

Locations

1 site across 1 country: United States