Timing of Bridge Plate Removal and Distal Radius Fracture Outcomes

Study Overview
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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).

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

Conditions
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Distal Radius Fracture

Intervention / Treatment
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* Procedure: Dorsal Spanning Bridge Plate Fixation
* Procedure: Dorsal Spanning Bridge Plate Removal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fracture of the distal radius indicated for operative treatment using bridge plate fixation Age 18 years or greater Capacity to provide informed consent Exclusion Criteria: Bridge plate fixation in the setting of revision surgery for prior nonunion or malunion 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) Pathologic fractures Patients that will be unable to complete the necessary follow up, including incarcerated patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bridge Plate Removal at 6-8 Weeks Postoperatively<br>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<br>* Dorsal spanning bridge fixation will be performed by board-certified orthopedic surgeons per standard technique.<br>Procedure: Dorsal Spanning Bridge Plate Removal<br>* Dorsal spanning bridge removal will be performed by board-certified orthopedic surgeons per standard technique.<br>|
| Active Comparator: Bridge Plate Removal at 12-14 Weeks Postoperatively<br>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<br>* Dorsal spanning bridge fixation will be performed by board-certified orthopedic surgeons per standard technique.<br>Procedure: Dorsal Spanning Bridge Plate Removal<br>* Dorsal spanning bridge removal will be performed by board-certified orthopedic surgeons per standard technique.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fracture of Lower End of Radius