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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Dorsal spanning bridge fixation will be performed by board-certified orthopedic surgeons per standard technique.
Dorsal spanning bridge removal will be performed by board-certified orthopedic surgeons per standard technique.
NYU Langone Health
New York, New York, United States
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.
Time frame: Baseline, Week 104
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Week 104