Distal Radius FractureTORPEDONCT05578612
Timing of Bridge Plate Removal and Distal Radius Fracture Outcomes
A study testing Dorsal Spanning Bridge Plate Fixation and Dorsal Spanning Bridge Plate Removal in people with Distal Radius Fracture, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Dorsal Spanning Bridge Plate Fixation and Dorsal Spanning Bridge Plate Removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2023to Jan 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fracture of the distal radius indicated for operative treatment using bridge plate fixation
- Age 18 years or greater
- Capacity to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Timing of Bridge Plate Removal and Distal Radius Fracture Outcomes: A Multicenter Randomized, Controlled Trial
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
- Being tested
- Dorsal Spanning Bridge Plate Fixation, Dorsal Spanning Bridge Plate Removal
- Keywords
- Fracture of Lower End of Radius
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dorsal Spanning Bridge Plate FixationProcedure or surgery
Dorsal spanning bridge fixation will be performed by board-certified orthopedic surgeons per standard technique.
Dorsal Spanning Bridge Plate RemovalProcedure or surgery
Dorsal spanning bridge removal will be performed by board-certified orthopedic surgeons per standard technique.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Dorsal Spanning Bridge Plate Fixation; Procedure: Dorsal Spanning Bridge Plate Removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 104
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start5 Jan 2023
- Primary completionJan 2026 (estimated)
- Study completionJan 2028 (estimated)
Why it stopped: Study withdrawn following PI departure from Sponsor institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Azad, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578612
- Sponsor's protocol ID
- 22-01142
- Acronym
- TORPEDO
- Status last verified
- Dec 2024
- First submitted
- 11 Oct 2022
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Bridge Plate Removal and Distal Radius Fracture Outcomes: A Multicenter Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05578612
- Acronym / sponsor ID
- TORPEDO / 22-01142
- Conditions
- Distal Radius Fracture
- Keywords
- Fracture of Lower End of Radius
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn following PI departure from Sponsor institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bridge Plate Removal at 6-8 Weeks Postoperatively | Experimental | Procedure: Dorsal Spanning Bridge Plate Fixation, Procedure: Dorsal Spanning Bridge Plate RemovalParticipants 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. |
| Bridge Plate Removal at 12-14 Weeks Postoperatively | Active comparator | Procedure: Dorsal Spanning Bridge Plate Fixation, Procedure: Dorsal Spanning Bridge Plate RemovalParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fracture of the distal radius indicated for operative treatment using bridge plate fixation
- Age 18 years or greater
- Capacity to provide informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dorsal Spanning Bridge Plate FixationDorsal spanning bridge fixation will be performed by board-certified orthopedic surgeons per standard technique. | Procedure or surgery | Bridge Plate Removal at 12-14 Weeks Postoperatively, Bridge Plate Removal at 6-8 Weeks Postoperatively |
| Dorsal Spanning Bridge Plate RemovalDorsal spanning bridge removal will be performed by board-certified orthopedic surgeons per standard technique. | Procedure or surgery | Bridge Plate Removal at 12-14 Weeks Postoperatively, Bridge Plate Removal at 6-8 Weeks Postoperatively |
Primary outcome
Change in Disabilities of the Arm, Shoulder, and Hand (DASH) Score
Time frame: Baseline, Week 104
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.
12 secondary outcomes
Change in Patient-Related Wrist Evaluation (PRWE) Questionnaire Score
Time frame: Baseline, Week 104
Change in Volar Tilt
Time frame: Removal of Bridge Plate (from Week 6 to up to Week 14), Week 104
Change in Radial Inclination
Time frame: Removal of Bridge Plate (from Week 6 to up to Week 14), Week 104
Change in Radial Height
Time frame: Removal of Bridge Plate (from Week 6 to up to Week 14), Week 104
Change in Ulnar Variance
Time frame: Removal of Bridge Plate (from Week 6 to up to Week 14), Week 104
Range of Motion: Flexion-Extension Arc Relative to Contralateral Side
Time frame: Up to Week 104
Range of Motion: Pronosupination Arc Relative to Contralateral Side
Time frame: Up to Week 104
Range of Motion: Ulnar-Radial Deviation Arc Relative to Contralateral Side
Time frame: Up to Week 104
Isometric Force: Grip Force Relative to Contralateral Side
Time frame: Up to Week 104
Isometric Force: Wrist Extension Force Relative to Contralateral Side
Time frame: Up to Week 104
Isometric Force: Wrist Flexion Force Relative to Contralateral Side
Time frame: Up to Week 104
Incidence of Nonunion at Surgical Site
Time frame: Up to Week 104
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Azad, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dorsal Spanning Bridge Plate Fixation and Dorsal Spanning Bridge Plate Removal in people with Distal Radius Fracture, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Disabilities of the Arm, Shoulder, and Hand (DASH) Score (time frame: Baseline, Week 104). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.