Scaphoid FractureNCT04776551
Percutaneous Fixation of Acute Scaphoid Fractures
A study testing Percutaneous fixation of acute Scaphoid fractures in people with Scaphoid Fracture, run by Sohag University at 1 site in Egypt.
Trial summary
Percutaneous Trans-trapezial fixation of acute Scaphoid fractures by Herbert screw Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Scaphoid Fracture
- What is being tested?
- Percutaneous fixation of acute Scaphoid fractures
- 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 1 May 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- - Acute stable non displaced waist fracture (A2).
- Acute unstable oblique distal third (B1).
- Acute unstable displaced waist (B2).
- Acute un stable fracture dislocation (B4).
- Acute un stable comminuted fracture (B5).
Who cannot join
- - Acute stable fracture tubercle (A1).
- Acute unstable fracture proximal pole (B3).
- Delayed union fracture (C).
- Established non-union fracture includes fibrous (D1) and sclerotic (D2).
- Bilateral fractures because of possible interference with postoperative grip strength measurement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Percutaneous Trans-trapezial Fixation of Acute Scaphoid Fractures by Herbert Screw
Percutaneous Trans-trapezial fixation of acute Scaphoid fractures by Herbert screw
Read the detailed description
Aim of the work:
To assessment outcomes of percutaneous Trans-trapezial fixation of acute scaphoid fracture.
Operative Technique:
Anesthesia: carried out under general anesthesia or brachial plexus block and under tourniquet control.
Position: supine. Approach: Percutaneous Trans-trapezial fixation of acute Scaphoid fracture. Recording any intraoperative complication that may affect the result.
Postoperative Follow Up:
Short arm circular cast including the thumb will be applied. After 3 weeks, cast will be removed and exercises will start.
- Conditions
- Scaphoid Fracture
- Being tested
- Percutaneous fixation of acute Scaphoid fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous fixation of acute Scaphoid fracturesProcedure or surgery
Percutaneous Trans-trapezial fixation of acute Scaphoid fractures by Herbert screw
| Study group | Role | What they receive |
|---|---|---|
| group (1) | Other | group (1) who are complaining of acute scaphoid fractures,we will do percutaneous trans trapezial fixation of scaphoid by Herbert screw.Short arm circular cast including the thumb will be applied. After 3 weeks, cast will be removed and exercises will start. Receives: Procedure: Percutaneous fixation of acute Scaphoid fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of wrist power
Modified Mayo wrist score
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Apr 2021
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scaphoid 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
- 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, Mahmoud Mohamed Mohamed Hamadouh, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776551
- Sponsor's protocol ID
- Soh-Med-21-2-09
- Status last verified
- Jun 2022
- First submitted
- 14 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
- Percutaneous Trans-trapezial Fixation of Acute Scaphoid Fractures by Herbert Screw
- ClinicalTrials.gov ID
- NCT04776551
- Acronym / sponsor ID
- Soh-Med-21-2-09
- Conditions
- Scaphoid Fracture
- 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 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 1 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.
Percutaneous Trans-trapezial fixation of acute Scaphoid fractures by Herbert screw
Detailed description
Aim of the work:
To assessment outcomes of percutaneous Trans-trapezial fixation of acute scaphoid fracture.
Operative Technique:
Anesthesia: carried out under general anesthesia or brachial plexus block and under tourniquet control.
Position: supine. Approach: Percutaneous Trans-trapezial fixation of acute Scaphoid fracture. Recording any intraoperative complication that may affect the result.
Postoperative Follow Up:
Short arm circular cast including the thumb will be applied. After 3 weeks, cast will be removed and exercises will start.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group (1) | Other | Procedure: Percutaneous fixation of acute Scaphoid fracturesgroup (1) who are complaining of acute scaphoid fractures,we will do percutaneous trans trapezial fixation of scaphoid by Herbert screw.Short arm circular cast including the thumb will be applied. After 3 weeks, cast will be removed and exercises will start. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- - Acute stable non displaced waist fracture (A2).
- Acute unstable oblique distal third (B1).
- Acute unstable displaced waist (B2).
- Acute un stable fracture dislocation (B4).
- Acute un stable comminuted fracture (B5).
Key exclusion criteria (5 listed)
- - Acute stable fracture tubercle (A1).
- Acute unstable fracture proximal pole (B3).
- Delayed union fracture (C).
- Established non-union fracture includes fibrous (D1) and sclerotic (D2).
- Bilateral fractures because of possible interference with postoperative grip strength measurement.
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 |
|---|---|---|
| Percutaneous fixation of acute Scaphoid fracturesPercutaneous Trans-trapezial fixation of acute Scaphoid fractures by Herbert screw | Procedure or surgery | group (1) |
Primary outcome
Change of wrist power
Time frame: Up to 18 months
Modified Mayo wrist score
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 Percutaneous fixation of acute Scaphoid fractures in people with Scaphoid 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 5 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?
Change of wrist power (time frame: Up to 18 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 21 Jun 2022.