Timing of Bridge Plate Removal and Distal Radius Fracture Outcomes (TORPEDO)

Timing of Bridge Plate Removal and Distal Radius Fracture Outcomes: A Multicenter Randomized, Controlled Trial

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).

Study Overview

• Status: Withdrawn
• Conditions: Distal Radius Fracture
• Intervention / Treatment: Procedure: Dorsal Spanning Bridge Plate Fixation; Procedure: Dorsal Spanning Bridge Plate Removal

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 11215
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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
Experimental: 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.	Procedure: Dorsal Spanning Bridge Plate Fixation; Dorsal spanning bridge fixation will be performed by board-certified orthopedic surgeons per standard technique.; Procedure: Dorsal Spanning Bridge Plate Removal; Dorsal spanning bridge removal will be performed by board-certified orthopedic surgeons per standard technique.
Active Comparator: 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.	Procedure: Dorsal Spanning Bridge Plate Fixation; Dorsal spanning bridge fixation will be performed by board-certified orthopedic surgeons per standard technique.; Procedure: Dorsal Spanning Bridge Plate Removal; Dorsal spanning bridge removal will be performed by board-certified orthopedic surgeons per standard technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Disabilities of the Arm, Shoulder, and Hand (DASH) Score	30-item questionnaire that asks the patient to rate their difficulty with common functional tasks and the severity of upper extremity symptoms over the past week. DASH is reported on a scale of 0-100 with lower scores indicating less severe symptoms and superior function. A decrease in scores indicates symptoms became less severe and function improved during the observational period.	Baseline, Week 104

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient-Related Wrist Evaluation (PRWE) Questionnaire Score	15-item questionnaire related to wrist pain and function during typical activities of daily living. Items are rated on a Likert scale from 0 (no pain or difficulty) to 10 (the worst pain you have ever experienced or you could not do the task). The total score ranges from 0-100; higher scores indicate greater disability. An increase in scores indicates disability increased during the observational period.	Baseline, Week 104
Change in Volar Tilt	Approximation of displacement in the sagittal plane. Radiographs taken immediately after bridge plate removal will be compared to final radiographs at the conclusion of the study period.	Removal of Bridge Plate (from Week 6 to up to Week 14), Week 104
Change in Radial Inclination	Approximation of displacement in the coronal plane. Radiographs taken immediately after bridge plate removal will be compared to final radiographs at the conclusion of the study period.	Removal of Bridge Plate (from Week 6 to up to Week 14), Week 104
Change in Radial Height	Approximation of displacement in the coronal plane. Radiographs taken immediately after bridge plate removal will be compared to final radiographs at the conclusion of the study period.	Removal of Bridge Plate (from Week 6 to up to Week 14), Week 104
Change in Ulnar Variance	Approximation of displacement in the coronal plane. Radiographs taken immediately after bridge plate removal will be compared to final radiographs at the conclusion of the study period.	Removal of Bridge Plate (from Week 6 to up to Week 14), Week 104
Range of Motion: Flexion-Extension Arc Relative to Contralateral Side	Range of Motion (ROM) will be measured using a digital goniometer. The ROM of the operative extremity will be expressed as a percentage of the operative wrist ROM relative to the uninjured wrist ROM. The arc of motion will be measured 3 times per visit and averaged for both the operative extremity and the contralateral extremity.	Up to Week 104
Range of Motion: Pronosupination Arc Relative to Contralateral Side	Range of Motion (ROM) will be measured using a digital goniometer. The ROM of the operative extremity will be expressed as a percentage of the operative wrist ROM relative to the uninjured wrist ROM. The arc of motion will be measured 3 times per visit and averaged for both the operative extremity and the contralateral extremity.	Up to Week 104
Range of Motion: Ulnar-Radial Deviation Arc Relative to Contralateral Side	Range of Motion (ROM) will be measured using a digital goniometer. The ROM of the operative extremity will be expressed as a percentage of the operative wrist ROM relative to the uninjured wrist ROM. The arc of motion will be measured 3 times per visit and averaged for both the operative extremity and the contralateral extremity.	Up to Week 104
Isometric Force: Grip Force Relative to Contralateral Side	Isometric force will be measured using a handheld dynamometer. Force measurements will be repeated 3 times per visit in both extremities. The force produced by the operative extremity will be expressed as a percentage of the operative wrist force relative to the uninjured wrist force.	Up to Week 104
Isometric Force: Wrist Extension Force Relative to Contralateral Side	Isometric force will be measured using a handheld dynamometer. Force measurements will be repeated 3 times per visit in both extremities. The force produced by the operative extremity will be expressed as a percentage of the operative wrist force relative to the uninjured wrist force.	Up to Week 104
Isometric Force: Wrist Flexion Force Relative to Contralateral Side	Isometric force will be measured using a handheld dynamometer. Force measurements will be repeated 3 times per visit in both extremities. The force produced by the operative extremity will be expressed as a percentage of the operative wrist force relative to the uninjured wrist force.	Up to Week 104
Incidence of Nonunion at Surgical Site	Nonunions will be defined based on the presence of both clinical and radiographic evidence of failed bony union after 8 weeks as agreed upon by two independent orthopedic surgeons. Pain, tenderness, and detectible motion at the fracture site will serve as clinical indicators of nonunion. Lack of bridging callus at the fracture site on plain radiographs taken coplanar with the fracture will serve as direct evidence of nonunion.	Up to Week 104

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Ali Azad, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2023
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: October 11, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Fracture of Lower End of Radius
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Wrist Injuries; Wrist Fractures; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: 22-01142

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Ali.Azad@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• 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 will have access to the data upon reasonable request. Requests should be directed to Ali.Azad@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