Metacarpal FractureNCT06611124
Surgical Evaluation of Fixation of Hand Metacarpals Fractures With K-wires
A study testing k -wires fixation for metacarpals fractures in people with Metacarpal Fracture, run by Mohamed Ali Helmi at 2 sites in Egypt.
Trial summary
different techniques have been described forfracture fixation ofmetacarpals fracture withk-wires being the most described technique as it is minimally invasive methodsfor metacarpals fractures in this research ,we are aimingto evaluate k-wire fixation of metacarpal fracture to optimize the clical outcome as regardsto… Read more about this study
- Who is it for?
- Ages 3 days and olderHealthy volunteers can take part
- Conditions the study is for
- Metacarpal Fracture
- What is being tested?
- k -wires fixation for metacarpals fractures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 11 Aug 2023to 31 Aug 2024
- 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 3 days and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- all patients with metacarpal fracture
Who cannot join
- patients with abnormal hand function before surgery
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Mohamed Ali Helmi Farghali
Sohag, Asyut Governorate
Mohamed Ali Helmi
Sohag
About this study
different techniques have been described forfracture fixation ofmetacarpals fracture withk-wires being the most described technique as it is minimally invasive methodsfor metacarpals fractures in this research ,we are aimingto evaluate k-wire fixation of metacarpal fracture to optimize the clical outcome as regardsto the degree of stiffnessas avouding the impairment of the gluding tissue of the fingers
Read the detailed description
hand fractures is about 19%of all fractures k-wires fixation is the most frequently method operative procedure which provide operative stability,early mobilization and excellent functional results primary option for fixation of theses fractures include k-wires ,plateand screws and more recently headless intramedullay compression scres and Bouquet k -wire technique Aim of work fir evaluation of the clinical,functional and radiological outcome of metacarpals fractures fixed by k -wires with variious techniques as antigrade intramedullay k-wires,transverse pinning of unstable displaced shaft and neck fractures.
also direct orif for intra articular head fractures Materials and Methods we are analyzing all patients with metacarpals fractures except patients abnormal hands fuctions before injury procedure done under general anesthesia ,brachial plexus block and wrist block outcome and evaluation handgrip strength 3 month after surgery Geniometer for range of motion AP ,Lateral and oblique radiograph
- Conditions
- Metacarpal Fracture
- Being tested
- k -wires fixation for metacarpals fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
k -wires fixation for metacarpals fracturesProcedure or surgery
reduction and fixation of metacarpal fracture with k-wire
| Study group | Role | What they receive |
|---|---|---|
| k -wires | Other | fixation of hand metacarpals fractures with k-wire 2 arms Receives: Procedure: k -wires fixation for metacarpals fractures |
| k -wire | Other | fixation of hand metacarpals fractures with k-wire 2 arms Receives: Procedure: k -wires fixation for metacarpals fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
hand grip by goniometer
hand grip by goniometer
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start11 Aug 2023
- Primary completion1 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metacarpal FractureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- reduction with axial traction to disimpact the fracture with dorsal pressure for metacarpals shfat and head fractures pinng of the fracture with k-wire for fixation
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Ali Helmi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Ali Helmi, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611124
- Sponsor's protocol ID
- Soh-Med-24-05-01MD
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Geissler WB. Operative fixation of metacarpal and phalangeal fractures in athletes. Hand Clin. 2009 Aug;25(3):409-21. doi: 10.1016/j.hcl.2009.05.005.
PubMed 19643340Kozin SH, Thoder JJ, Lieberman G. Operative treatment of metacarpal and phalangeal shaft fractures. J Am Acad Orthop Surg. 2000 Mar-Apr;8(2):111-21. doi: 10.5435/00124635-200003000-00005.
PubMed 10799096Moore A, Varacallo MA. Metacarpal Hand Fracture. 2023 Aug 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK536960/
PubMed 30725645
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Evaluation of Fixation of Hand Metacarpals Fractures With K-wires
- ClinicalTrials.gov ID
- NCT06611124
- Acronym / sponsor ID
- Soh-Med-24-05-01MD
- Conditions
- Metacarpal Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mohamed Ali HelmiUniversity, hospital or other
- Study start
- 11 Aug 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 24 Sep 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.
different techniques have been described forfracture fixation ofmetacarpals fracture withk-wires being the most described technique as it is minimally invasive methodsfor metacarpals fractures in this research ,we are aimingto evaluate k-wire fixation of metacarpal fracture to optimize the clical outcome as regardsto the degree of stiffnessas avouding the impairment of the gluding tissue of the fingers
Detailed description
hand fractures is about 19%of all fractures k-wires fixation is the most frequently method operative procedure which provide operative stability,early mobilization and excellent functional results primary option for fixation of theses fractures include k-wires ,plateand screws and more recently headless intramedullay compression scres and Bouquet k -wire technique Aim of work fir evaluation of the clinical,functional and radiological outcome of metacarpals fractures fixed by k -wires with variious techniques as antigrade intramedullay k-wires,transverse pinning of unstable displaced shaft and neck fractures.
also direct orif for intra articular head fractures Materials and Methods we are analyzing all patients with metacarpals fractures except patients abnormal hands fuctions before injury procedure done under general anesthesia ,brachial plexus block and wrist block outcome and evaluation handgrip strength 3 month after surgery Geniometer for range of motion AP ,Lateral and oblique radiograph
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- reduction with axial traction to disimpact the fracture with dorsal pressure for metacarpals shfat and head fractures pinng of the fracture with k-wire for fixation
| Arm | Type | Receives |
|---|---|---|
| k -wires | Other | Procedure: k -wires fixation for metacarpals fracturesfixation of hand metacarpals fractures with k-wire 2 arms |
| k -wire | Other | Procedure: k -wires fixation for metacarpals fracturesfixation of hand metacarpals fractures with k-wire 2 arms |
Who may qualify
- Ages
- 3 days and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients with metacarpal fracture
Key exclusion criteria (1 listed)
- patients with abnormal hand function before surgery
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 |
|---|---|---|
| k -wires fixation for metacarpals fracturesreduction and fixation of metacarpal fracture with k-wire | Procedure or surgery | k -wire, k -wires |
Primary outcome
hand grip by goniometer
Time frame: one year
hand grip by goniometer
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 24 Sep 2024.
- Results publication: PubMed 19643340Geissler WB. Operative fixation of metacarpal and phalangeal fractures in athletes. Hand Clin. 2009 Aug;25(3):409-21. doi: 10.1016/j.hcl.2009.05.005.
- Results publication: PubMed 10799096Kozin SH, Thoder JJ, Lieberman G. Operative treatment of metacarpal and phalangeal shaft fractures. J Am Acad Orthop Surg. 2000 Mar-Apr;8(2):111-21. doi: 10.5435/00124635-200003000-00005.
- Results publication: PubMed 30725645Moore A, Varacallo MA. Metacarpal Hand Fracture. 2023 Aug 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK536960/
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing k -wires fixation for metacarpals fractures in people with Metacarpal Fracture, run by Mohamed Ali Helmi at 2 sites 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 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
hand grip by goniometer (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06611124, which also lists 3 linked publications.
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 24 Sep 2024.