Timing of Bridge Plate Removal and Distal Radius Fracture Outcomes

NCT05578612 | Withdrawn

• 1 other identifier: 22-01142
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Distal Radius Fracture

Keywords

Fracture of Lower End of Radius

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Change in Patient-Related Wrist Evaluation (PRWE) Questionnaire Score

  Baseline, Week 104

• Change in Volar Tilt

  Removal of Bridge Plate (from Week 6 to up to Week 14), Week 104

• Change in Radial Inclination

  Removal of Bridge Plate (from Week 6 to up to Week 14), Week 104

• Change in Radial Height

  Removal of Bridge Plate (from Week 6 to up to Week 14), Week 104

• Change in Ulnar Variance

  Removal of Bridge Plate (from Week 6 to up to Week 14), Week 104

Study Arms (2)

Bridge Plate Removal at 6-8 Weeks Postoperatively

EXPERIMENTAL

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; Procedure: Dorsal Spanning Bridge Plate Removal

Bridge Plate Removal at 12-14 Weeks Postoperatively

ACTIVE COMPARATOR

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; Procedure: Dorsal Spanning Bridge Plate Removal

Interventions

Dorsal Spanning Bridge Plate Fixation PROCEDURE

Dorsal spanning bridge fixation will be performed by board-certified orthopedic surgeons per standard technique.

Bridge Plate Removal at 12-14 Weeks Postoperatively; Bridge Plate Removal at 6-8 Weeks Postoperatively

Dorsal Spanning Bridge Plate Removal PROCEDURE

Dorsal spanning bridge removal will be performed by board-certified orthopedic surgeons per standard technique.

Bridge Plate Removal at 12-14 Weeks Postoperatively; Bridge Plate Removal at 6-8 Weeks Postoperatively

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fracture of the distal radius indicated for operative treatment using bridge plate fixation
• Age 18 years or greater
• Capacity to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 11215, United States

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Ali Azad, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 13, 2022
• Study Start: January 5, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)