Metacarpal FractureNCT06631924
Intramedullary Fixation for Metacarpal Fractures: A Prospective Study Comparing Outcomes
An observational study of Metacarpal Fracture, run by University of Colorado, Denver at 1 site in United States.
Trial summary
To prove that use of intramedullary cannulated headless hardware fixation of metacarpal fractures provides anatomic reduction, stable fixation, less operative trauma and early, active post-operative mobilization. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metacarpal Fracture
- What is being tested?
- Implant
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2020to 16 Apr 2024
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who undergo hand surgery at University of Colorado Hospital and Denver Health Medical Center for surgical treatment of closed extraarticular metacarpal fracture(s). Fracture classification will be based off of AO Foundation/Orthopaedic Trauma Association guidelines and radiographic interpretation • Non-operative Cohort: Patients who underwent non-operative management of closed extra-articular metacarpal fractures at both the University of Colorado and Denver Health Medical Center will also be reviewed.
Inclusion Criteria:Patients who undergo hand surgery at University of Colorado Hospital and Denver Health Medical Center for surgical treatment of closed extraarticular metacarpal fracture(s). Fracture classification will be based off of AO Foundation/Orthopaedic Trauma Association guidelines and radiographic interpretation
- Non-operative Cohort: Patients who underwent non-operative management of closed extra-articular metacarpal fractures at both the University of Colorado and Denver Health Medical Center will also be reviewed.
Exclusion Criteria: Open metacarpal fractures (defined as any fracture associated with a laceration or break in skin continuity near the fracture site)
- Patients with previous history of metacarpal nonunion or malunion corrections on the affected digit
- Metacarpal fractures with intraarticular extension
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
To prove that use of intramedullary cannulated headless hardware fixation of metacarpal fractures provides anatomic reduction, stable fixation, less operative trauma and early, active post-operative mobilization. The study compares two types of implant to determine efficacy in reduction and maintenance of reduction for fracture healing.
Read the detailed description
To prove that use of intramedullary cannulated headless hardware fixation of metacarpal fractures provides anatomic reduction, stable fixation, less operative trauma and early, active post-operative mobilization. The study compares two types of implant to determine efficacy in reduction and maintenance of reduction for fracture healing
- Conditions
- Metacarpal Fracture
- Being tested
- Implant
- Keywords
- fractures metacrapal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImplantDevice
Intramedullary headless hardware systems were utilized to place hardware in85 a retrograde manner from the metacarpophalangeal joint.
| Study group | Role | What they receive |
|---|---|---|
| • Operative Cohort: Patients who undergo hand surgery at University of Colorado Hospital and Denver | • Operative Cohort: Patients who undergo hand surgery at University of Colorado Hospital and Denver Health Medical Center for surgical treatment of closed extraarticular metacarpal fracture(s). Fracture classification will be based off of AO Foundation/Orthopaedic Trauma Association guidelines and radiographic interpretation Receives: Device: Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative primary Outcomes
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) outcome measure score.
Measured: 30 Days
Secondary outcomes (3)
Pain scale
Pain quantified on Graphic Rating Scale (GRS)
Measured: 30-days
Measurement of range
Goniometer measurements of range of motion at metacarpophalangeal joint (MP), proximal interphalangeal joint (PIP), distal interphalangeal joint (DIP), in addition to any extensor lag at the MP joint.
Measured: 30-days
Operative complications
Operative complications including but not limited to: bone nonunion and malunion, superficial and deep infections, hardware failure, stiffness, revision surgery and tendon adhesions/rupture.
Measured: 30-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start23 Apr 2020
- Primary completion16 Apr 2024
- Study completion16 Apr 2024
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 University of Colorado, DenverThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matt Iorio, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631924
- Sponsor's protocol ID
- 20-0802
- Status last verified
- Oct 2024
- First submitted
- 24 Sep 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramedullary Fixation for Metacarpal Fractures: A Prospective Study Comparing Outcomes
- ClinicalTrials.gov ID
- NCT06631924
- Acronym / sponsor ID
- 20-0802
- Conditions
- Metacarpal Fracture
- Keywords
- fractures metacrapal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 16 Apr 2024 (actual)
- Study completion
- 16 Apr 2024 (actual)
- First posted
- 8 Oct 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.
To prove that use of intramedullary cannulated headless hardware fixation of metacarpal fractures provides anatomic reduction, stable fixation, less operative trauma and early, active post-operative mobilization. The study compares two types of implant to determine efficacy in reduction and maintenance of reduction for fracture healing.
Detailed description
To prove that use of intramedullary cannulated headless hardware fixation of metacarpal fractures provides anatomic reduction, stable fixation, less operative trauma and early, active post-operative mobilization. The study compares two types of implant to determine efficacy in reduction and maintenance of reduction for fracture healing
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| • Operative Cohort: Patients who undergo hand surgery at University of Colorado Hospital and Denver | – | Device: Implant• Operative Cohort: Patients who undergo hand surgery at University of Colorado Hospital and Denver Health Medical Center for surgical treatment of closed extraarticular metacarpal fracture(s). Fracture classification will be based off of AO Foundation/Orthopaedic Trauma Association guidelines and radiographic interpretation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who undergo hand surgery at University of Colorado Hospital and Denver Health Medical Center for surgical treatment of closed extraarticular metacarpal fracture(s). Fracture classification will be based off of AO Foundation/Orthopaedic Trauma Association guidelines and radiographic interpretation • Non-operative Cohort: Patients who underwent non-operative management of closed extra-articular metacarpal fractures at both the University of Colorado and Denver Health Medical Center will also be reviewed.
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 |
|---|---|---|
| ImplantIntramedullary headless hardware systems were utilized to place hardware in85 a retrograde manner from the metacarpophalangeal joint. | Device | • Operative Cohort: Patients who undergo hand surgery at University of Colorado Hospital and Denver |
Primary outcome
Post-operative primary Outcomes
Time frame: 30 Days
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) outcome measure score.
3 secondary outcomes
Pain scale
Time frame: 30-days
Measurement of range
Time frame: 30-days
Operative complications
Time frame: 30-days
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 8 Oct 2024.
- Individual participant dataSharing planned: Yes
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.
Matt Iorio, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metacarpal Fracture, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 8 Oct 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 United States. 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?
Post-operative primary Outcomes (time frame: 30 Days). 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 8 Oct 2024.