Timing of Bridge Plate Removal and Distal Radius Fracture Outcomes (TORPEDO)

NYU Langone Health

Status: Withdrawn

Conditions: Distal Radius Fracture

Treatments: Procedure: Dorsal Spanning Bridge Plate Fixation; Procedure: Dorsal Spanning Bridge Plate Removal

Study type: Interventional

Funder types: Other

Identifiers

NCT05578612

22-01142

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Bridge Plate Removal at 6-8 Weeks Postoperatively

Experimental group

Description:

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.

Treatment:

Procedure: Dorsal Spanning Bridge Plate Removal

Procedure: Dorsal Spanning Bridge Plate Fixation

Bridge Plate Removal at 12-14 Weeks Postoperatively

Active Comparator group

Description:

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.

Treatment:

Procedure: Dorsal Spanning Bridge Plate Removal

Procedure: Dorsal Spanning Bridge Plate Fixation