Back to resultsTiming of Bridge Plate Removal and Distal Radius Fracture Outcomes (TORPEDO)
Primary Purpose
Distal Radius Fracture
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dorsal Spanning Bridge Plate Fixation
Dorsal Spanning Bridge Plate Removal
Sponsored by
About this trial
This is an interventional treatment trial for Distal Radius Fracture focused on measuring Fracture of Lower End of Radius
Eligibility Criteria
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
Sites / Locations
- NYU Langone HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bridge Plate Removal at 6-8 Weeks Postoperatively
Bridge Plate Removal at 12-14 Weeks Postoperatively
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05578612
Brief Title
Timing of Bridge Plate Removal and Distal Radius Fracture Outcomes
Acronym
TORPEDO
Official Title
Timing of Bridge Plate Removal and Distal Radius Fracture Outcomes: A Multicenter Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture
Keywords
Fracture of Lower End of Radius
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bridge Plate Removal at 6-8 Weeks Postoperatively
Arm Type
Experimental
Arm 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.
Arm Title
Bridge Plate Removal at 12-14 Weeks Postoperatively
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Dorsal Spanning Bridge Plate Fixation
Intervention Description
Dorsal spanning bridge fixation will be performed by board-certified orthopedic surgeons per standard technique.
Intervention Type
Procedure
Intervention Name(s)
Dorsal Spanning Bridge Plate Removal
Intervention Description
Dorsal spanning bridge removal will be performed by board-certified orthopedic surgeons per standard technique.
Primary Outcome Measure Information:
Title
Change in Disabilities of the Arm, Shoulder, and Hand (DASH) Score
Description
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
Secondary Outcome Measure Information:
Title
Change in Patient-Related Wrist Evaluation (PRWE) Questionnaire Score
Description
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
Title
Change in Volar Tilt
Description
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
Title
Change in Radial Inclination
Description
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
Title
Change in Radial Height
Description
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
Title
Change in Ulnar Variance
Description
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
Title
Range of Motion: Flexion-Extension Arc Relative to Contralateral Side
Description
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
Title
Range of Motion: Pronosupination Arc Relative to Contralateral Side
Description
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
Title
Range of Motion: Ulnar-Radial Deviation Arc Relative to Contralateral Side
Description
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
Title
Isometric Force: Grip Force Relative to Contralateral Side
Description
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
Title
Isometric Force: Wrist Extension Force Relative to Contralateral Side
Description
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
Title
Isometric Force: Wrist Flexion Force Relative to Contralateral Side
Description
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
Title
Incidence of Nonunion at Surgical Site
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Azad, MD
Phone
212-598-6000
Email
Ali.Azad@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew T Kingery, MD
Phone
212-598-6000
Email
matthew.kingery@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Azad, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Azad, MD
Phone
212-598-6000
Email
Ali.Azad@nyulangone.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Ali.Azad@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing 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.
IPD Sharing 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.
Learn more about this trial
Timing of Bridge Plate Removal and Distal Radius Fracture Outcomes
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