Distal Radius FracturesNCT06723483
Results Of Usage Of Bridging Plate In Multi-fragmentary Distal Radius Fracture
An observational study of Distal Radius Fractures and Mechanical Complication of Internal Rod Fixation Device, run by Mina Hany Moris Zakhary at 1 site in Egypt.
Trial summary
using a plate as a distraction method bridging the comminution to restore anatomical parameters to treat comminuted distal radius fracture follow-up functional outcomes of the wrist after metal removal Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fractures, Mechanical Complication of Internal Rod Fixation Device, Internal Fixation; Complications
- What is being tested?
- Distraction Plate
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: oFirst peak is the young exposed to high energy trauma , fall from a height, polytrauma patients with extensive communition of metaphyseal and articular parts oSecond peak is old (over 60 years),with osteoporotic bone where even minor falls can cause extensive comminution
Who may be able to join
- Skeletally mature patients
- presented with multifragmentary distal radius fractures classify type 23-3C according to AO classification
- articular with or without metaphyseal comminution
- Very distal fractures 5 )osteoporotic bone fractures
Who cannot join
- Dorsal soft tissue defect or tendon injuries
- Metacarpal fractures (esp 2end MC)
- open grade 3 fractures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Results of Usage of Bridging Plate in Multi-fragmentary Distal Radius Fracture
using a plate as a distraction method bridging the comminution to restore anatomical parameters to treat comminuted distal radius fracture follow-up functional outcomes of the wrist after metal removal
Read the detailed description
The plate is extended from the floor of the 2end extensor compartment at an intact radius to the 2end metacarpal by dual minimally invasive skin incisions.
One distal over 2end metacarpal and Other proximal over 2end extensor compartment at intact radius application of distal screws 1st, then the traction is done to restore radial length, radial inclination, and volar tilt followed by the application of proximal screws add wires to restore the joint congruity wire removal after 45 days, plate removal after 100 day follow up every 3 months till 1 year post-operative Assess the Functional Outcome Of the wrist joint after metal removal
- Conditions
- Distal Radius Fractures, Mechanical Complication of Internal Rod Fixation Device, Internal Fixation; Complications
- Being tested
- Distraction Plate
- Keywords
- bridging plate, distraction plate
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distraction PlateProcedure or surgery
Also called bride plating, bridging plate
This technique deals with comminuted distal radius fracture using a distraction plate. The plate was inserted by minimally invasive skin incisions, fixed from the 2end metacarpal distally to the 2end extensor compartment at intact radius proximally Spaning the comminution, Restoring the Radial Length, Radial Inclination, Volar Tilt
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Mayo Wrist Score (MMWS)
Combines subjective and objective parameters to evaluate wrist functionality.
Measured: Mean follow-up period is 1 year postoperative.
Secondary outcomes (1)
Wrist Range of Movement
Measurements include:
Flexion (degrees) Extension (degrees) Pronation (degrees) Supination (degrees) Each measurement will be assessed separately using a goniometer.
Measured: Mean follow-up period is 1 year postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Jan 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mina Hany Moris Zakhary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mina Hany Moris Zakhary, Assiut University
- Investigators
- Waleed Riad Saleh Waleed Riad Saleh Ramadan, preso doctor, Study chair, assiut university hospitalsYasser Farouk Yasser Mohamed Farouk Fouad Ragheb, doctor, Study director, assiut university hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723483
- Sponsor's protocol ID
- 04-2024-200841
- Status last verified
- Dec 2024
- First submitted
- 3 Oct 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of Usage of Bridging Plate in Multi-fragmentary Distal Radius Fracture
- ClinicalTrials.gov ID
- NCT06723483
- Acronym / sponsor ID
- 04-2024-200841
- Conditions
- Distal Radius Fractures, Mechanical Complication of Internal Rod Fixation Device, Internal Fixation; Complications
- Keywords
- bridging plate, distraction plate
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mina Hany Moris ZakharyUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 9 Dec 2024 (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.
using a plate as a distraction method bridging the comminution to restore anatomical parameters to treat comminuted distal radius fracture follow-up functional outcomes of the wrist after metal removal
Detailed description
The plate is extended from the floor of the 2end extensor compartment at an intact radius to the 2end metacarpal by dual minimally invasive skin incisions.
One distal over 2end metacarpal and Other proximal over 2end extensor compartment at intact radius application of distal screws 1st, then the traction is done to restore radial length, radial inclination, and volar tilt followed by the application of proximal screws add wires to restore the joint congruity wire removal after 45 days, plate removal after 100 day follow up every 3 months till 1 year post-operative Assess the Functional Outcome Of the wrist joint after metal removal
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- oFirst peak is the young exposed to high energy trauma , fall from a height, polytrauma patients with extensive communition of metaphyseal and articular parts oSecond peak is old (over 60 years),with osteoporotic bone where even minor falls can cause extensive comminution
Key inclusion criteria (4 listed)
- Skeletally mature patients
- presented with multifragmentary distal radius fractures classify type 23-3C according to AO classification
- articular with or without metaphyseal comminution
- Very distal fractures 5 )osteoporotic bone fractures
Key exclusion criteria (3 listed)
- Dorsal soft tissue defect or tendon injuries
- Metacarpal fractures (esp 2end MC)
- open grade 3 fractures
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 |
|---|---|---|
| Distraction PlateAlso: bride plating, bridging plateThis technique deals with comminuted distal radius fracture using a distraction plate. The plate was inserted by minimally invasive skin incisions, fixed from the 2end metacarpal distally to the 2end extensor compartment at intact radius proximally Spaning the comminution, Restoring the Radial Length, Radial Inclination, Volar Tilt | Procedure or surgery | – |
Primary outcome
Modified Mayo Wrist Score (MMWS)
Time frame: Mean follow-up period is 1 year postoperative.
Combines subjective and objective parameters to evaluate wrist functionality.
1 secondary outcome
Wrist Range of Movement
Time frame: Mean follow-up period is 1 year postoperative.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: Yes
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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.
Waleed Riad Saleh Waleed Riad Saleh Ramadan, preso doctor study chair
assiut university hospitals
Yasser Farouk Yasser Mohamed Farouk Fouad Ragheb, doctor study director
assiut university hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Distal Radius Fractures and Mechanical Complication of Internal Rod Fixation Device, run by Mina Hany Moris Zakhary at 1 site in Egypt.
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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 9 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
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?
Modified Mayo Wrist Score (MMWS) (time frame: Mean follow-up period is 1 year postoperative.). 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 9 Dec 2024.