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?

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.

Study Overview

• Status: Recruiting
• Conditions: Distal Radius Fracture
• Intervention / Treatment: Other: Splint; Behavioral: Formal Physical Therapy; Behavioral: Self directed physical therapy; Other: Soft dressing (No Splint)

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 Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jadie DeTolla, MD; Phone Number: 631-786-4552; Email: jadie.detolla@nyulangone.org
• Study Contact Backup: Name: Victoria Comunale; Email: victoria.comunale@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone
      • Contact: Jadie De Tolla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Jadie De Tolla, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2020
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (Actual): March 27, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Wrist Injuries; Fractures, Bone; Radius Fractures; Wrist Fractures
• Other Study ID Numbers: 19-01584

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to jadie.detolla@nyulangone.org To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No