Timing of Bridge Plate Removal and Distal Radius Fracture Outcomes

Distal Radius Fracture Clinical Trial

— TORPEDO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05578612
• Other study ID #: 22-01142
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2023
• Est. completion date: January 2028

Study information

• Verified date: January 2024
• Source: NYU Langone Health
• Contact: Ali Azad, MD
• Phone: 212-598-6000
• Email: Ali.Azad[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2028
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	NYU Langone Health	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	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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