Distal Radius FractureNCT04798846
Fixation of Comminuted Distal Radius Fracture
A study testing dorsal plating in people with Distal Radius Fracture, run by Sohag University at 1 site in Egypt.
Trial summary
comparison between different methods in fixation of comminuted distal radius fractures Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- dorsal plating
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 1 Apr 2022
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Skeletally mature patients aging 18 or more
- Comminuted distal radius fractures Fernandez type V
Who cannot join
- Age less than 18 year or more
- Patients with previous fracture affecting wrist joint in the same side.
- Parients with active infection in the affected joint
- Pathological fracture
- Neurological disorder (epilepsy…etc) Reheumatoid
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spanning Plate Versus Spanning External Fixator in Fixation of Comminuted Distal Radius Fracture
comparison between different methods in fixation of comminuted distal radius fractures
Read the detailed description
This clinical study aims at comparison of treatment outcomes of Spanning plate versus spanning External fixator in fixation of comminuted distal radius fracture.
The primary outcomes that we like to measure are pain, healing. Stiffness and range of motion .
- Conditions
- Distal Radius Fracture
- Being tested
- dorsal plating
- Keywords
- distal radius fracture
- 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 platingProcedure or surgery
Also called External fixator
Spanning Plate inserted dorsally below tendons Spanning External Fixator by rods inserted in distal radius and metacarpals
| Study group | Role | What they receive |
|---|---|---|
| External fixator | Active comparator | patient treated by external fixator Receives: Procedure: dorsal plating |
| Dorsal plate | Active comparator | patient treated by dorsal spanning plate Receives: Procedure: dorsal plating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mayo modified wrist score
measure.grip strength
Measured: up to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start1 Apr 2021
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
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 Sohag 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eslam Abdelnaby Abdelsabor, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798846
- Sponsor's protocol ID
- Soh_Med_21_02_11
- Status last verified
- Jun 2022
- First submitted
- 23 Feb 2021
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spanning Plate Versus Spanning External Fixator in Fixation of Comminuted Distal Radius Fracture
- ClinicalTrials.gov ID
- NCT04798846
- Acronym / sponsor ID
- Soh_Med_21_02_11
- Conditions
- Distal Radius Fracture
- Keywords
- distal radius fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 15 Mar 2021 (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.
comparison between different methods in fixation of comminuted distal radius fractures
Detailed description
This clinical study aims at comparison of treatment outcomes of Spanning plate versus spanning External fixator in fixation of comminuted distal radius fracture.
The primary outcomes that we like to measure are pain, healing. Stiffness and range of motion .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External fixator | Active comparator | Procedure: dorsal platingpatient treated by external fixator |
| Dorsal plate | Active comparator | Procedure: dorsal platingpatient treated by dorsal spanning plate |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
Key exclusion criteria (5 listed)
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 platingAlso: External fixatorSpanning Plate inserted dorsally below tendons Spanning External Fixator by rods inserted in distal radius and metacarpals | Procedure or surgery | Dorsal plate, External fixator |
Primary outcome
Mayo modified wrist score
Time frame: up to 6 month
measure.grip strength
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 plating in people with Distal Radius Fracture, run by Sohag University 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 21 Jun 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mayo modified wrist score (time frame: up to 6 month). 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 21 Jun 2022.