Metacarpal FractureNCT06210191
Intramedullary Headless Screw Fixation for Metacarpal and Phalangeal Fractures
A study testing Intramedullary headless screw fixation in people with Metacarpal Fracture and Phalanx Fracture, run by Assiut University at 1 site in Egypt.
Trial summary
Intramedullary headless screw fixation for metacarpal and phalangeal fractures Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Metacarpal Fracture, Phalanx Fracture
- What is being tested?
- Intramedullary headless screw fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2024to Mar 2025
- 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 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Skeletally mature patients with closed fractures of phalanges and metacarpals.
- Patients with open type I fractures of phalanges and metacarpals.
Who cannot join
- Skeletally immature patients with open physis.
- Patients with open type II or III fractures of phalanges or metacarpals.
- Patients with fractures of phalanges or metacarpals with neurovascular injury. 4 Patients with associated tendon injuries.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of medicine
Asyut, 71515
Waleed Riad, professor, +201142123037, Drwaleedriad@gmail.com
About this study
Intramedullary headless screw fixation for metacarpal and phalangeal fractures
Read the detailed description
The most frequent fractures in the upper extremities are phalangeal and metacarpal fractures accounts about 40%, which follow distal radius fractures in order of frequency.
There are many methods of fixation of these fractures as plates and K-wires. Plate fixation is able to provide open reduction and stability for early range of motion with mixed clinical results. Reported complications include stiffness, fixed flexion contracture of the adjacent joints, soft tissue dissection, and extensor lag.
There are minimally invasive techniques, including the use of K-wires, lag screws, cerclage wiring, and external fixation that limit soft tissue dissection. These options have drawbacks of malunion, nonunion, infection, need for hardware removal, and stiffness.
Intramedullary headless screw fixation is an emerging alternative to K-wire or plate fixation of displaced and unstable fractures of the phalanges and metacarpals. The Intramedullary headless screw fixation is a new option that offers rigid stability, early active range of motion, and easy insertion. Due to the minimally invasive nature of this technique, patients will experience better results in terms of range of motion, return to work faster, and minimize complications.
Beck et al. reported 100% of patients achieved full radiological union with minor complication rate and full range of motion and early return to work with average 96% of grip strength.
- Conditions
- Metacarpal Fracture, Phalanx Fracture
- Being tested
- Intramedullary headless screw fixation
- Keywords
- intramedullary headless screw fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramedullary headless screw fixationProcedure or surgery
fixation of fractures of metacarpals and phalanges by intramedullary headless screws
| Study group | Role | What they receive |
|---|---|---|
| union of fracture | Experimental | Intramedullary headless screw fixation for metacarpal and phalangeal fractures Receives: Procedure: Intramedullary headless screw fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieve full range of motion of hand joints
Change DASH Score of hand functions to 0 by this intervention. As 0 is excellent and 100 is the worst outcome
Measured: 6 weeks for active range of motion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study startMar 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metacarpal FractureStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelrahman Megahed Ahmed, Assiut University
- Investigators
- Amr Elsayed, professor, Study chair, Assiut UniversityWaleed Riad, professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210191
- Sponsor's protocol ID
- Intramedullary screw fixation
- Status last verified
- Feb 2024
- First submitted
- 18 Dec 2023
- Last updated
- 9 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available. all collected IPD, all IPD that underlie results in a publication)
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramedullary Headless Screw Fixation for Metacarpal and Phalangeal Fractures
- ClinicalTrials.gov ID
- NCT06210191
- Acronym / sponsor ID
- Intramedullary screw fixation
- Conditions
- Metacarpal Fracture, Phalanx Fracture
- Keywords
- intramedullary headless screw fixation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 18 Jan 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.
Intramedullary headless screw fixation for metacarpal and phalangeal fractures
Detailed description
The most frequent fractures in the upper extremities are phalangeal and metacarpal fractures accounts about 40%, which follow distal radius fractures in order of frequency.
There are many methods of fixation of these fractures as plates and K-wires. Plate fixation is able to provide open reduction and stability for early range of motion with mixed clinical results. Reported complications include stiffness, fixed flexion contracture of the adjacent joints, soft tissue dissection, and extensor lag.
There are minimally invasive techniques, including the use of K-wires, lag screws, cerclage wiring, and external fixation that limit soft tissue dissection. These options have drawbacks of malunion, nonunion, infection, need for hardware removal, and stiffness.
Intramedullary headless screw fixation is an emerging alternative to K-wire or plate fixation of displaced and unstable fractures of the phalanges and metacarpals. The Intramedullary headless screw fixation is a new option that offers rigid stability, early active range of motion, and easy insertion. Due to the minimally invasive nature of this technique, patients will experience better results in terms of range of motion, return to work faster, and minimize complications.
Beck et al. reported 100% of patients achieved full radiological union with minor complication rate and full range of motion and early return to work with average 96% of grip strength.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| union of fracture | Experimental | Procedure: Intramedullary headless screw fixationIntramedullary headless screw fixation for metacarpal and phalangeal fractures |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Skeletally mature patients with closed fractures of phalanges and metacarpals.
- Patients with open type I fractures of phalanges and metacarpals.
Key exclusion criteria (3 listed)
- Skeletally immature patients with open physis.
- Patients with open type II or III fractures of phalanges or metacarpals.
- Patients with fractures of phalanges or metacarpals with neurovascular injury. 4 Patients with associated tendon injuries.
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 |
|---|---|---|
| Intramedullary headless screw fixationfixation of fractures of metacarpals and phalanges by intramedullary headless screws | Procedure or surgery | union of fracture |
Primary outcome
Achieve full range of motion of hand joints
Time frame: 6 weeks for active range of motion
Change DASH Score of hand functions to 0 by this intervention. As 0 is excellent and 100 is the worst outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available. all collected IPD, all IPD that underlie results in a publication)
Related trials for Metacarpal Fracture
Recruiting
Buddy Tape vs. Splint for Metacarpal Shaft Fracture Recovery
Non-thumb Metacarpal Shaft Fracture
Not yet recruiting
Repair of Extra-articular Fractures of the Metacarpals and First Phalanges of the Long Fingers
Hand Fractures
Recruiting
Evaluation of Diaphragmatic Function After Interscalene Block With Liposomal Bupivacaine
Diaphragmatic Function, Metacarpal Fracture
RecruitingObservational study
The CARBO CARBON Study
Metacarpal Shaft Fractures, Greenhouse Gas Emissions
Not yet recruiting
Intramedullary Screw Fixation Versus Closed Reduction and Percutaneous Pinning With Cast Immobilization
Metacarpal Fracture, Phalanx 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.
Amr Elsayed, professor study chair
Assiut University
Waleed Riad, professor study director
Assiut 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 Intramedullary headless screw fixation in people with Metacarpal Fracture and Phalanx Fracture, run by Assiut 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 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: status not confirmed, as of the sponsor's last update on 9 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Megahed, resident (+201007712309, megahed117@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achieve full range of motion of hand joints (time frame: 6 weeks for active range of motion). 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 Feb 2024.