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Timing of Bridge Plate Removal and Distal Radius Fracture Outcomes

NCT ID: NCT05578612

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-05

Study Completion Date

2028-01-31

Brief Summary

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The purpose of this randomized control trial will be to determine whether the duration of bridge plate fixation of distal radius fractures can be reduced to 6-8 weeks without worsening of functional outcomes relative to the current standard of greater than 12 weeks of fixation. The secondary aim of the study is to determine whether a reduced duration of bridge plate fixation leads to an increase in wrist range of motion following plate removal compared to the standard duration of fixation. 100 patients with comminuted distal radius fractures that are indicated for bridge plate fixation will be randomized to the Accelerated Removal arm (n = 50) or the Standard Removal arm (n = 50).

Detailed Description

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Conditions

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Distal Radius Fracture

Keywords

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Fracture of Lower End of Radius

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bridge Plate Removal at 6-8 Weeks Postoperatively

Participants will undergo dorsal spanning bridge plate fixation per standard technique. Patients in the experimental group will return to the operative room for removal of the bridge plate at Week 6-8. Patients will begin the standardized postoperative rehabilitation protocol immediately following bridge plate removal on Week 6-8.

Group Type EXPERIMENTAL

Dorsal Spanning Bridge Plate Fixation

Intervention Type PROCEDURE

Dorsal spanning bridge fixation will be performed by board-certified orthopedic surgeons per standard technique.

Dorsal Spanning Bridge Plate Removal

Intervention Type PROCEDURE

Dorsal spanning bridge removal will be performed by board-certified orthopedic surgeons per standard technique.

Bridge Plate Removal at 12-14 Weeks Postoperatively

Participants will undergo dorsal spanning bridge plate fixation per standard technique. Patients in the control group will return to the operating room for removal of the bridge plate at Week 12-14. Patients will begin the standardized postoperative rehabilitation protocol immediately following bridge plate removal on Week 12-14.

Group Type ACTIVE_COMPARATOR

Dorsal Spanning Bridge Plate Fixation

Intervention Type PROCEDURE

Dorsal spanning bridge fixation will be performed by board-certified orthopedic surgeons per standard technique.

Dorsal Spanning Bridge Plate Removal

Intervention Type PROCEDURE

Dorsal spanning bridge removal will be performed by board-certified orthopedic surgeons per standard technique.

Interventions

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Dorsal Spanning Bridge Plate Fixation

Dorsal spanning bridge fixation will be performed by board-certified orthopedic surgeons per standard technique.

Intervention Type PROCEDURE

Dorsal Spanning Bridge Plate Removal

Dorsal spanning bridge removal will be performed by board-certified orthopedic surgeons per standard technique.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Fracture of the distal radius indicated for operative treatment using bridge plate fixation
2. Age 18 years or greater
3. Capacity to provide informed consent

Exclusion Criteria

1. Bridge plate fixation in the setting of revision surgery for prior nonunion or malunion
2. Bilateral distal radius fractures (prevents accurate measurement of postoperative range of motion and strength of the injured extremity without a normal contralateral extremity for comparison)
3. Pathologic fractures
4. Patients that will be unable to complete the necessary follow up, including incarcerated patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ali Azad, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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22-01142

Identifier Type: -

Identifier Source: org_study_id