Distal Radius FractureNCT04100317
Spanning Bridged Plate in Comminuted Distal Radius Fractures
An observational study of Distal Radius Fracture, run by Assiut University.
Trial summary
This study To evaluate the result of using spanning bridge plate in comminuted distal radius fractures. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Distal Radius Fracture
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2019to 20 Oct 2020
- Phase
- Observational
- 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 to 60 years
- All sexes
- Adult
Study population: Troumatized population with age 18 to 60 years old with comminuted intra articular distal radius fractures.
Who may be able to join
- age 18-60 years old
- early trouma (within two weeks)
Who cannot join
- open fractures
- concomitant limb injuries
- old fractures more than two weeks
- sever osteoporosis and osteopenia.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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 .
- Conditions
- Distal Radius Fracture
- Keywords
- Pridge plate
- Medical subject headings
- Wrist Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrist range of movement
Degree measurment of wrist Flexion. Extension radial and ulnur deviatin
Measured: Baseline
Secondary outcomes (3)
Radilogical parameters
By taking new xrays and exactly calculate the distal radius angels and parameters by calculate the exact deviatin
Measured: Baseline
Grip strength
By using grip strength power
Measured: Baseline
Union
Assesment of union condition by Dexa scan
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start20 Sep 2019 (estimated)
- Primary completion20 Sep 2020 (estimated)
- Study completion20 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anass Abdeslam kabbour Hanzaz, Assiut University
- Investigators
- Amr Pr Elsayed, Study director, Proffissor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100317
- Sponsor's protocol ID
- Bpf in distal radius fractures
- Status last verified
- Sep 2019
- First submitted
- 20 Sep 2019
- Last updated
- 24 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 26034446Geller 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.
PubMed 19865547Mann 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.
PubMed 26929853
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Result of Spanning Bridge Plate Fixation for Comminuted Intra Articular Distal Radial Fractures.
- ClinicalTrials.gov ID
- NCT04100317
- Acronym / sponsor ID
- Bpf in distal radius fractures
- Conditions
- Distal Radius Fracture
- Keywords
- Pridge plate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Sep 2019 (estimated)
- Primary completion
- 20 Sep 2020 (estimated)
- Study completion
- 20 Oct 2020 (estimated)
- First posted
- 24 Sep 2019 (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.
This study To evaluate the result of using spanning bridge plate in comminuted distal radius fractures.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Troumatized population with age 18 to 60 years old with comminuted intra articular distal radius fractures.
Key inclusion criteria (2 listed)
- age 18-60 years old
- early trouma (within two weeks)
Key exclusion criteria (4 listed)
- open fractures
- concomitant limb injuries
- old fractures more than two weeks
- sever osteoporosis and osteopenia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Wrist range of movement
Time frame: Baseline
Degree measurment of wrist Flexion. Extension radial and ulnur deviatin
3 secondary outcomes
Radilogical parameters
Time frame: Baseline
Grip strength
Time frame: Baseline
Union
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Background: PubMed 26034446Matullo 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.
- Background: PubMed 19865547Geller 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.
- Background: PubMed 26929853Mann 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.
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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.
Amr Pr Elsayed study director
Proffissor
Questions about this trial
What is this clinical trial studying?
An observational study of Distal Radius Fracture, run by Assiut University.
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 2 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: status not confirmed, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anass Dr Hanzaz, Master (+201026081677, Doctoranass@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wrist range of movement (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04100317, which also lists 3 linked publications.
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 Sep 2019.