Distal Ulna FracturesNCT04792060
Management of Distal Ulna Fractures Using Hook Plate
A study testing Hook plate in people with Distal Ulna Fractures, run by Sohag University at 1 site in Egypt.
Trial summary
The aim of this current prospective study is to evaluate the effectiveness of an open reduction and internal fixation {ORIF} by distal ulna hooked locking compression plate (lcp) in treatment of isolated displaced distal ulna fracture in adult " without concomitant distal radius fractures. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Distal Ulna Fractures
- What is being tested?
- Hook plate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 20 Nov 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Skeletally mature distal ulna fracture with or without radius fracture.
Who cannot join
- Pathological fracture Skeletally immaturity Neurovascular problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study of the Management of Distal Ulna Fractures Using Hook Plate in Adult
The aim of this current prospective study is to evaluate the effectiveness of an open reduction and internal fixation {ORIF} by distal ulna hooked locking compression plate (lcp) in treatment of isolated displaced distal ulna fracture in adult " without concomitant distal radius fractures.
Read the detailed description
The distal ulna is an important component in the forearm and wrist motion. Pronation-supination is a complex movement, combining the rotation of the radius around the ulna with a horizontal and axial translation. If the distal ulna fails to heal in the proper anatomical position maintaining its original length with significant residual angulation at the fracture site, and separation of the DRUJ in a transverse axis, then a more severe limitation of forearm motion
- Conditions
- Distal Ulna Fractures
- Being tested
- Hook 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.
Hook plateProcedure or surgery
Also called Distal ulna anatomical plate
We used titanium 2.4 mm hooked distal ulnar locked plate used for fixation of distal ulna fractures , this plate have low profile which is anatomically precontoured
| Study group | Role | What they receive |
|---|---|---|
| adult patients with distal ulna fractures | Experimental | adult patients with distal ulna fractures Receives: Procedure: Hook plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Management of Distal Ulna Fractures Using Hook Plate
surgery
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Apr 2021
- Primary completion1 Nov 2022
- Study completion20 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Ulna FracturesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fathy Tawfik, Sohag University
- Investigators
- salah roshdy ahmed, professor, Study chair, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792060
- Sponsor's protocol ID
- Soh-Med-21-02-10
- Status last verified
- Mar 2023
- First submitted
- 20 Feb 2021
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: • Patient still for 24 hours postoperative till discharge during this period follow up swelling and neurovascular complication and broad spectrum antibiotics will be taken. Follow up of cases at 2weeks postoperative 1-3-6 months.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of the Management of Distal Ulna Fractures Using Hook Plate in Adult
- ClinicalTrials.gov ID
- NCT04792060
- Acronym / sponsor ID
- Soh-Med-21-02-10
- Conditions
- Distal Ulna Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 20 Nov 2022 (actual)
- First posted
- 10 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.
The aim of this current prospective study is to evaluate the effectiveness of an open reduction and internal fixation {ORIF} by distal ulna hooked locking compression plate (lcp) in treatment of isolated displaced distal ulna fracture in adult " without concomitant distal radius fractures.
Detailed description
The distal ulna is an important component in the forearm and wrist motion. Pronation-supination is a complex movement, combining the rotation of the radius around the ulna with a horizontal and axial translation. If the distal ulna fails to heal in the proper anatomical position maintaining its original length with significant residual angulation at the fracture site, and separation of the DRUJ in a transverse axis, then a more severe limitation of forearm motion
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult patients with distal ulna fractures | Experimental | Procedure: Hook plateadult patients with distal ulna fractures |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Skeletally mature distal ulna fracture with or without radius fracture.
Key exclusion criteria (1 listed)
- Pathological fracture Skeletally immaturity Neurovascular problems
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 |
|---|---|---|
| Hook plateAlso: Distal ulna anatomical plateWe used titanium 2.4 mm hooked distal ulnar locked plate used for fixation of distal ulna fractures , this plate have low profile which is anatomically precontoured | Procedure or surgery | adult patients with distal ulna fractures |
Primary outcome
Management of Distal Ulna Fractures Using Hook Plate
Time frame: 6 months
surgery
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 10 Mar 2023.
- Individual participant dataSharing planned: No. • Patient still for 24 hours postoperative till discharge during this period follow up swelling and neurovascular complication and broad spectrum antibiotics will be taken. Follow up of cases at 2weeks postoperative 1-3-6 months.
Related trials for Distal Ulna Fractures
Recruiting
Evaluation of Dual Fixation of Distal Ulna Fractures by Flexible Intramedullary Nail and Mini Locked Plate 2.7 mm.
Distal Ulna Fracture
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.
salah roshdy ahmed, professor study chair
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hook plate in people with Distal Ulna Fractures, 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 1 inclusion and 1 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 10 Mar 2023. 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?
Management of Distal Ulna Fractures Using Hook Plate (time frame: 6 months). 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 10 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.