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

Distal Radius Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04324580
• Other study ID #: 19-01584
• Status: Recruiting
• Phase: N/A
• Start date: June 18, 2020
• Est. completion date: October 1, 2024

Study information

• Verified date: January 2024
• Source: NYU Langone Health
• Contact: Jadie DeTolla, MD
• Phone: 631-786-4552
• Email: jadie.detolla[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: October 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures
• Wrist Fractures

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	NYU Langone	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change in wrist range mobility	Range of motion will be measured using goniometers.	2 weeks, 4 weeks, 12 weeks, 24 weeks
Secondary	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
Secondary	Change in Grip strength	Physical examinations through the study will record the grip strength (kgs)	2 weeks, 4 weeks, 12 weeks, 24 weeks