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Distal Radius FractureNCT04100317

Spanning Bridged Plate in Comminuted Distal Radius Fractures

An observational study of Distal Radius Fracture, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Anass Dr Hanzaz, Master contact

+201026081677

Doctoranass@gmail.com

Mohamed Dr Morsy, Proffissor contact

+201099021770

Amrelmicro@yahoo.com

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 .

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.

  1. Wrist range of movement

    Degree measurment of wrist Flexion. Extension radial and ulnur deviatin

    Measured: Baseline

Secondary outcomes (3)
  1. Radilogical parameters

    By taking new xrays and exactly calculate the distal radius angels and parameters by calculate the exact deviatin

    Measured: Baseline

  2. Grip strength

    By using grip strength power

    Measured: Baseline

  3. 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.

  1. First posted24 Sep 2019
  2. Study start20 Sep 2019 (estimated)
  3. Primary completion20 Sep 2020 (estimated)
  4. Study completion20 Oct 2020 (estimated)

Resources

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)
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 26034446
  • 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.

    PubMed 19865547
  • 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.

    PubMed 26929853

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.

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