- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04100317
Spanning Bridged Plate in Comminuted Distal Radius Fractures
September 20, 2019 updated by: Anass Abdeslam kabbour Hanzaz, Assiut University
Result of Spanning Bridge Plate Fixation for Comminuted Intra Articular Distal Radial Fractures.
This study To evaluate the result of using spanning bridge plate in comminuted distal radius fractures.
Study Overview
Status
Unknown
Conditions
Detailed Description
Distal radius fractures are the most common long bone fracture and the incidence appears to be increasing worldwide.
They have been found to account for approximately 17% of all fracture-related emergency department visits.
These types of injuries have a bimodal age distribution.
The first peak represents young patients involved in high energy traumas, and the second peak represents elderly patients with lower to moderate energy injuries secondary to osteoporosis.Surgical treatment for distal radius fractures varies, as there are numerous techniques for fixation.
The goals of fixation are anatomic reduction and stability, as this has been shown to result in improved chances for functional recovery .
The use of volar locking plateshas become the standard for treatment of the majority of distal radius fractures requiring surgery .
However, adequate fixation for high energy comminuted fractures with or without metadia-physeal extension remains a major treatment challenge.
Severely comminuted articular fractures are technically challenging in terms of obtaining an adequate reduction and achieving stabilization with a standard periarticular volar plating technique.
The small fracture fragments are often not able to be stabilized with the screws from the volar plate, and the proximally-oriented tension from the forearm musculature acts to pull on the carpus causing further collapse of the articular surface.
As an alternate to the volar plate, these types of injuries have been historically treated with an external fixator with or without Kirschner wires.
However, it has been reported that highly comminuted distal radius fractures are associated with a 52%-63% complication rate when treated with external fixation .
Therefore, despite poor fixation capabilities withthese fracturetypes,thevolarplate remainsthego-to devicefor most surgeons when faced with comminuted articular distal radial fractures.
In these circumstances, the dorsal distraction plate (also called dorsal "bridge" plating technique) can serve as an improved fixation technique by allowing comminuted articular fragments to reduce under ligamentotaxis and provide a buttress for the dorsal cortex of the distal radius.
In addition, a long dorsal plate can bridge past metaphyseal comminution, which cannot be so easily addressed with standard volar plating .
The bridge plate can also be left in place for an extended period of time without the risk of the aforementioned complications of prolonged external fixation use .
Finally, the dorsal distraction plate is technically a much easier operation to perform than volar plating for complex articular fractures.
Recently, there has been increased use of dorsal distraction plating for these types of injuries .
Study Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Troumatized population with age 18 to 60 years old with comminuted intra articular distal radius fractures.
Description
Inclusion Criteria:
- age 18-60 years old
- early trouma (within two weeks)
Exclusion Criteria:
- open fractures
- concomitant limb injuries
- old fractures more than two weeks
- sever osteoporosis and osteopenia.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wrist range of movement
Time Frame: Baseline
|
Degree measurment of wrist Flexion.
Extension radial and ulnur deviatin
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Radilogical parameters
Time Frame: Baseline
|
By taking new xrays and exactly calculate the distal radius angels and parameters by calculate the exact deviatin
|
Baseline
|
|
Grip strength
Time Frame: Baseline
|
By using grip strength power
|
Baseline
|
|
Union
Time Frame: Baseline
|
Assesment of union condition by Dexa scan
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Amr Pr Elsayed, Proffissor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Matullo KS, Dennison DG. Outcome following distally locked volar plating for distal radius fractures with metadiaphyseal involvement. Hand (N Y). 2015 Jun;10(2):292-6. doi: 10.1007/s11552-014-9713-z.
- Geller L, Bernstein M, Carli A, Berry G, Reindl R, Harvey E. Efficacy of different fixation devices in maintaining an initial reduction for surgically managed distal radius fractures. Can J Surg. 2009 Oct;52(5):E161-6.
- Mann T, Lee DJ, Dahl J, Elfar JC. Can Radiocarpal-Spanning Fixation Be Made More Functional by Placing the Wrist in Extension? A Biomechanical Study Under Physiologic Loads. Geriatr Orthop Surg Rehabil. 2016 Mar;7(1):23-9. doi: 10.1177/2151458515621109.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 20, 2019
Primary Completion (Anticipated)
September 20, 2020
Study Completion (Anticipated)
October 20, 2020
Study Registration Dates
First Submitted
September 20, 2019
First Submitted That Met QC Criteria
September 20, 2019
First Posted (Actual)
September 24, 2019
Study Record Updates
Last Update Posted (Actual)
September 24, 2019
Last Update Submitted That Met QC Criteria
September 20, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bpf in distal radius fractures
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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