Metacarpal FractureNCT02718170
Buried Intramedullary K-wire Fixation Compared With Plate and Screw Fixation for Metacarpal Fractures in Unstable Extra-Articular Metacarpal Fractures
A study testing Buried Intramedullary K-wire Fixation and Plate and Screw Fixation in people with Metacarpal Fracture, run by Prisma Health-Upstate.
Trial summary
Randomized controlled trial comparing a technique for buried intramedullary k-wire fixation to plate and screw fixation for unstable extra-articular metacarpal fractures. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Metacarpal Fracture
- What is being tested?
- Buried Intramedullary K-wire Fixation and Plate and Screw Fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to 26 Aug 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patient has an unstable extra-articular metacarpal fracture that meets operative indications
- Informed consent is obtained from the patient or proxy
- Male or female who are 16 years of age or older
Who cannot join
- If the patients range of motion was decreased prior to injury (previous upper extremity injury, osteoarthritis, etc.)
- Pathological Fracture
- Greater than 21 days from fracture to definitive open reduction and internal fixation
- If contamination or wounds from open fractures do not permit standardized buried intramedullary fixation or plate and screw fixation
- Highly comminuted diaphyseal fractures
- Articular fractures
- Multiple fractures involving bones other than another metacarpal in the same upper extremity
- The patient had a previous upper extremity injury that has limited hand function or finger range of motion
About this study
Official title: Buried Intramedullary K-wire Fixation Compared With Plate and Screw Fixation in Unstable Extra-Articular Metacarpal Fractures: A Randomized, Controlled Study
Randomized controlled trial comparing a technique for buried intramedullary k-wire fixation to plate and screw fixation for unstable extra-articular metacarpal fractures.
Read the detailed description
Metacarpal fractures are a common injury to the hand. Most fractures occur due to direct force from either a axial load to the dorsum of the metacarpophalangeal joint or low energy fall onto an outstretched hand. Many of these fractures can be treated closed with a closed reduction and splinting however, some displaced or angulated fractures require open reduction and internal fixation. Many fixation techniques have been used, however to the investigators knowledge, no one has prospectively randomized patients to compare plate and screw fixation with buried intramedullary k-wire fixation.
The purpose of this study is to compare Plate and screw and buried intramedullary fixation, using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire as the primary outcome measured. Secondary outcomes will include total active motion, complications, cost, reoperation rate.
- Conditions
- Metacarpal Fracture
- Being tested
- Buried Intramedullary K-wire Fixation, Plate and Screw Fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buried Intramedullary K-wire FixationProcedure or surgery
Plate and Screw FixationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Buried Intramedullary K-wire Fixation | Experimental | Patients randomized to buried intramedullary k-wire fixation will undergo a standardized antegrade open reduction and fixation procedure with an intramedullary k-wire. Receives: Procedure: Buried Intramedullary K-wire Fixation |
| Plate and Screw Fixation | Active comparator | Patients randomized to Plate and Screw Fixation will undergo a standardized open reduction and internal fixation with plate and screws. Brand of plate will be left to the operating surgeon's discretion. Receives: Procedure: Plate and Screw Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability as measured by Disability of Arm, Shoulder and Hand Score
Measured: 3 months
Secondary outcomes (3)
Total Active Motion in degrees
Measured by goniometer
Measured: 3 months
Grip Strength
Measured: 3 months
Disability as measured by Disability of Arm, Shoulder and Hand Score
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startMar 2015
- Primary completion26 Aug 2025
- Study completion26 Aug 2025
Why it stopped: Unable to meet enrollment goals and lack of patient follow-up
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.
- 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
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Millon, MD, Principal investigator, Prisma Health-Upstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718170
- Sponsor's protocol ID
- 00048356
- Status last verified
- Apr 2026
- First submitted
- 15 Mar 2016
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buried Intramedullary K-wire Fixation Compared With Plate and Screw Fixation in Unstable Extra-Articular Metacarpal Fractures: A Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT02718170
- Acronym / sponsor ID
- 00048356
- Conditions
- Metacarpal Fracture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to meet enrollment goals and lack of patient follow-up
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- 26 Aug 2025 (actual)
- Study completion
- 26 Aug 2025 (actual)
- First posted
- 24 Mar 2016 (estimated)
- 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.
Randomized controlled trial comparing a technique for buried intramedullary k-wire fixation to plate and screw fixation for unstable extra-articular metacarpal fractures.
Detailed description
Metacarpal fractures are a common injury to the hand. Most fractures occur due to direct force from either a axial load to the dorsum of the metacarpophalangeal joint or low energy fall onto an outstretched hand. Many of these fractures can be treated closed with a closed reduction and splinting however, some displaced or angulated fractures require open reduction and internal fixation. Many fixation techniques have been used, however to the investigators knowledge, no one has prospectively randomized patients to compare plate and screw fixation with buried intramedullary k-wire fixation.
The purpose of this study is to compare Plate and screw and buried intramedullary fixation, using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire as the primary outcome measured. Secondary outcomes will include total active motion, complications, cost, reoperation rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buried Intramedullary K-wire Fixation | Experimental | Procedure: Buried Intramedullary K-wire FixationPatients randomized to buried intramedullary k-wire fixation will undergo a standardized antegrade open reduction and fixation procedure with an intramedullary k-wire. |
| Plate and Screw Fixation | Active comparator | Procedure: Plate and Screw FixationPatients randomized to Plate and Screw Fixation will undergo a standardized open reduction and internal fixation with plate and screws. Brand of plate will be left to the operating surgeon's discretion. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- The patient has an unstable extra-articular metacarpal fracture that meets operative indications
- Informed consent is obtained from the patient or proxy
- Male or female who are 16 years of age or older
Key exclusion criteria (8 listed)
- If the patients range of motion was decreased prior to injury (previous upper extremity injury, osteoarthritis, etc.)
- Pathological Fracture
- Greater than 21 days from fracture to definitive open reduction and internal fixation
- If contamination or wounds from open fractures do not permit standardized buried intramedullary fixation or plate and screw fixation
- Highly comminuted diaphyseal fractures
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 |
|---|---|---|
| Buried Intramedullary K-wire Fixation | Procedure or surgery | Buried Intramedullary K-wire Fixation |
| Plate and Screw Fixation | Procedure or surgery | Plate and Screw Fixation |
Primary outcome
Disability as measured by Disability of Arm, Shoulder and Hand Score
Time frame: 3 months
3 secondary outcomes
Total Active Motion in degrees
Time frame: 3 months
Grip Strength
Time frame: 3 months
Disability as measured by Disability of Arm, Shoulder and Hand Score
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Unable to meet enrollment goals and lack of patient follow-up). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
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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.
John Millon, MD principal investigator
Prisma Health-Upstate
Questions about this trial
What is this clinical trial studying?
A study testing Buried Intramedullary K-wire Fixation and Plate and Screw Fixation in people with Metacarpal Fracture, run by Prisma Health-Upstate.
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 8 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: stopped early, as of the sponsor's last update on 15 Apr 2026. 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?
The study was stopped early (reason given: Unable to meet enrollment goals and lack of patient follow-up). Results are not available in the source record.
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?
Disability as measured by Disability of Arm, Shoulder and Hand Score (time frame: 3 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 15 Apr 2026.