Metacarpal FractureNCT04605341
Miniplate Versus k Wires in Management of Metacarpal Fracture
A study testing miniplate in people with Metacarpal Fracture, run by Assiut University.
Trial summary
To compare between buried k wires and miniplate in management of metacarpal fracture. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Metacarpal Fracture
- What is being tested?
- miniplate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 31 Dec 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: ( 20-60) years,
- Fresh (fixed within 3 days),
- Single or multiple fractures of metacarpals.
Who cannot join
- Pathological fracture,
- Major systemic illness, malignancy,
- Patient on drugs affecting fracture healing like steroid, anticancer drugs,
- Polytrauma patients,
- Extensive comminution of the metacarpal or phalanx detected pre- or intra-operatively,
- Dislocations at either end of the fractured bone
- Parents/guardians/patients not willing to participate in study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Study Between Miniplate and Buried k Wires in Management of Metacarpal Fractures
To compare between buried k wires and miniplate in management of metacarpal fracture.
Read the detailed description
Fractures of the carpals, metacarpals and phalanges account for approximately 15-19% of fractures in adults, with 59% of these occurring in the phalanges, 33% in the metacarpals and 8% in the carpal bones [1]. The single most common fracture site in the hand is the sub capital region of the fifth metacarpal bone (boxer's fracture) [2], which usually results from a direct blow to the metacarpal head [3]. Most hand fractures are caused by accidental falls or other sports-related injuries [4]. Hand fractures are among the most common fractures of upper extremity [5, 6]. Hand fractures can be treated conservatively or surgically, depending on the severity, location and type of fracture. The main objective of both operative and non-operative treatments is to provide fracture stability for early mobilization [7]. Surgical fixation is mainly indicated for displaced fractures because casts are often not sufficient to maintain reduction [8]. Open reduction with internal fixation (ORIF), using pins or plates, has historically been used to stabilize hand fractures which have rotational deformity or lateral angulation [9]. Open reduction may result in scarring, joint stiffness and tendon adhesion [7]. Closed reduction with internal fixation (CRIF), using percutaneous K wire or screws, is now used to treat the majority of unstable closed simple hand fractures [10]. It is generally considered percutaneous Kirschner wire (K wire) fixation may not provide adequate stabilization to allow for early mobilization [8] .
- Conditions
- Metacarpal Fracture
- Being tested
- miniplate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miniplateDevice
Also called k wires
comparison between k wires and miniplate in metacarpal fractures
| Study group | Role | What they receive |
|---|---|---|
| group one | Active comparator | patient with metacarpal fracture that will use minipate for fixation Receives: Device: miniplate |
| gruop two | Active comparator | patient with metacarpal fracture that will use buried k wires for fixation Receives: Device: miniplate |
What is being measured
The primary outcome is the main question the study is designed to answer.
miniplate,buried k wires and union
- To compare between union and healing in metacarpal fracture fixation by miniplate versus buried intramedullary k. wires by imaging using anteroposterior and lateral and oblique views x ray to determine union and healing by seeing bridging callus in two or more cortices
Measured: 6 month
Secondary outcomes (1)
Range of motion
- Range of motion using Functional range of motion (FROM) is defined as the minimum ROM necessary to comfortably and effectively perform ADL.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start1 Jan 2021 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion31 Dec 2022 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mina kamal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605341
- Sponsor's protocol ID
- miniplate,k wires and union
- Status last verified
- Sep 2020
- First submitted
- 12 Sep 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Miniplate and Buried k Wires in Management of Metacarpal Fractures
- ClinicalTrials.gov ID
- NCT04605341
- Acronym / sponsor ID
- miniplate,k wires and union
- Conditions
- Metacarpal Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 28 Oct 2020 (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.
To compare between buried k wires and miniplate in management of metacarpal fracture.
Detailed description
Fractures of the carpals, metacarpals and phalanges account for approximately 15-19% of fractures in adults, with 59% of these occurring in the phalanges, 33% in the metacarpals and 8% in the carpal bones [1]. The single most common fracture site in the hand is the sub capital region of the fifth metacarpal bone (boxer's fracture) [2], which usually results from a direct blow to the metacarpal head [3]. Most hand fractures are caused by accidental falls or other sports-related injuries [4]. Hand fractures are among the most common fractures of upper extremity [5, 6]. Hand fractures can be treated conservatively or surgically, depending on the severity, location and type of fracture. The main objective of both operative and non-operative treatments is to provide fracture stability for early mobilization [7]. Surgical fixation is mainly indicated for displaced fractures because casts are often not sufficient to maintain reduction [8]. Open reduction with internal fixation (ORIF), using pins or plates, has historically been used to stabilize hand fractures which have rotational deformity or lateral angulation [9]. Open reduction may result in scarring, joint stiffness and tendon adhesion [7]. Closed reduction with internal fixation (CRIF), using percutaneous K wire or screws, is now used to treat the majority of unstable closed simple hand fractures [10]. It is generally considered percutaneous Kirschner wire (K wire) fixation may not provide adequate stabilization to allow for early mobilization [8] .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group one | Active comparator | Device: miniplatepatient with metacarpal fracture that will use minipate for fixation |
| gruop two | Active comparator | Device: miniplatepatient with metacarpal fracture that will use buried k wires for fixation |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: ( 20-60) years,
- Fresh (fixed within 3 days),
- Single or multiple fractures of metacarpals.
Key exclusion criteria (7 listed)
- Pathological fracture,
- Major systemic illness, malignancy,
- Patient on drugs affecting fracture healing like steroid, anticancer drugs,
- Polytrauma patients,
- Extensive comminution of the metacarpal or phalanx detected pre- or intra-operatively,
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 |
|---|---|---|
| miniplateAlso: k wirescomparison between k wires and miniplate in metacarpal fractures | Device | group one, gruop two |
Primary outcome
miniplate,buried k wires and union
Time frame: 6 month
• To compare between union and healing in metacarpal fracture fixation by miniplate versus buried intramedullary k. wires by imaging using anteroposterior and lateral and oblique views x ray to determine union and healing by seeing bridging callus in two or more cortices
1 secondary outcome
Range of motion
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing miniplate in people with Metacarpal Fracture, run by Assiut University.
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 3 inclusion and 7 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 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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 mina kamal, resident (01203380329, minakamalcr7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
miniplate,buried k wires and union (time frame: 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 28 Oct 2020.