Clinical trial NCT04324580: Postoperative Immobilization and Physical Therapy Following Volar Locked Plating for Distal Radius Fractures
Official title: Postoperative Immobilization and Physical Therapy Following Volar Locked Plating for Distal Radius Fractures: Are They Necessary?
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Distal Radius Fracture
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

     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

Primary outcomes:
measure: Percentage of Loss of fixation
timeFrame: 2 weeks, 4 weeks, 12 weeks, 24 weeks
Secondary outcomes:
measure: Change in Patient comfort/pain (VAS)
timeFrame: Day of Surgery, 2 weeks, 4 weeks, 12 weeks, 24 weeks
measure: Change in wrist range mobility
timeFrame: 2 weeks, 4 weeks, 12 weeks, 24 weeks
measure: Change in wrist range mobility using DASH
timeFrame: 2 weeks, 4 weeks, 12 weeks, 24 weeks
measure: Change in Grip strength
timeFrame: 2 weeks, 4 weeks, 12 weeks, 24 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone
state: New York
Study officials:
affiliation: NYU Langone Health
name: Jadie De Tolla, MD
role: PRINCIPAL_INVESTIGATOR
References: