NCT04324580

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Jun 2020Aug 2027

First Submitted

Initial submission to the registry

March 5, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

June 18, 2020

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

7.1 years

First QC Date

March 5, 2020

Last Update Submit

March 26, 2026

Conditions

Distal Radius Fracture

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in Patient comfort/pain (VAS)

    Day of Surgery, 2 weeks, 4 weeks, 12 weeks, 24 weeks

  • Change in wrist range mobility

    2 weeks, 4 weeks, 12 weeks, 24 weeks

  • Change in wrist range mobility using DASH

    2 weeks, 4 weeks, 12 weeks, 24 weeks

  • Change in Grip strength

    2 weeks, 4 weeks, 12 weeks, 24 weeks

Study Arms (2)

Delayed mobilization/Formal physical therapy group

ACTIVE COMPARATOR

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: SplintBehavioral: Formal Physical Therapy

Immediate mobilization/self guided physical therapy group

ACTIVE COMPARATOR

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 therapyOther: Soft dressing (No Splint)

Interventions

SplintOTHER

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.

Delayed mobilization/Formal physical therapy group
Formal Physical TherapyBEHAVIORAL

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.

Delayed mobilization/Formal physical therapy group
Self directed physical therapyBEHAVIORAL

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.

Immediate mobilization/self guided physical therapy group
Soft dressing (No Splint)OTHER

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.

Immediate mobilization/self guided physical therapy group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Isolated displaced distal radius fractures, +/- ulnar styloid fracture, treated with volar locked plating and screws.
  • \> 10 degrees of dorsal tilt
  • Volar displacement (Volar Barton's type fracture)
  • Shortening \> 3 mm
  • Intra-articular displacement or step off \> 2mm.

You may not qualify if:

  • Ipsilateral upper limb concomitant fracture
  • Fracture fixation other than volar locked plating and screws
  • Dislocation or neurologic injury
  • Gustilo-Anderson grade III open fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Wrist Fractures

Interventions

Splints

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

External FixatorsOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentEquipment and SuppliesSurgical Fixation Devices

Study Officials

  • Jadie De Tolla, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2020

First Posted

March 27, 2020

Study Start

June 18, 2020

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Shared Documents
STUDY PROTOCOL, SAP
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.
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.

Locations

US(1)