Clinical trial NCT05578612: Timing of Bridge Plate Removal and Distal Radius Fracture Outcomes
Official title: Timing of Bridge Plate Removal and Distal Radius Fracture Outcomes: A Multicenter Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Distal Radius Fracture
Keywords: Fracture of Lower End of Radius
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Change in Disabilities of the Arm, Shoulder, and Hand (DASH) Score
timeFrame: Baseline, Week 104
Secondary outcomes:
measure: Change in Patient-Related Wrist Evaluation (PRWE) Questionnaire Score
timeFrame: Baseline, Week 104
measure: Change in Volar Tilt
timeFrame: Removal of Bridge Plate (from Week 6 to up to Week 14), Week 104
measure: Change in Radial Inclination
timeFrame: Removal of Bridge Plate (from Week 6 to up to Week 14), Week 104
measure: Change in Radial Height
timeFrame: Removal of Bridge Plate (from Week 6 to up to Week 14), Week 104
measure: Change in Ulnar Variance
timeFrame: Removal of Bridge Plate (from Week 6 to up to Week 14), Week 104
measure: Range of Motion: Flexion-Extension Arc Relative to Contralateral Side
timeFrame: Up to Week 104
measure: Range of Motion: Pronosupination Arc Relative to Contralateral Side
timeFrame: Up to Week 104
measure: Range of Motion: Ulnar-Radial Deviation Arc Relative to Contralateral Side
timeFrame: Up to Week 104
measure: Isometric Force: Grip Force Relative to Contralateral Side
timeFrame: Up to Week 104
measure: Isometric Force: Wrist Extension Force Relative to Contralateral Side
timeFrame: Up to Week 104
measure: Isometric Force: Wrist Flexion Force Relative to Contralateral Side
timeFrame: Up to Week 104
measure: Incidence of Nonunion at Surgical Site
timeFrame: Up to Week 104
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Ali Azad, MD
role: PRINCIPAL_INVESTIGATOR
References: