Fractures, ClosedNCT00610701
Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures
A study testing Anterior pin placement and Lateral pin placement in people with Fractures, Closed, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
The purpose of this study is to evaluate patients with tibial plateau fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fractures, Closed
- What is being tested?
- Anterior pin placement and Lateral pin placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Feb 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and above (adult population)
- All open and closed tibial plateau fractures
Who cannot join
- 17 years of age and less (pediatric population)
- Quadriplegic patients
- Vascular Injury to Extremity
- Ipsilateral femur fractures
- Ipsilateral Hip fractures
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate patients with tibial plateau fractures.
Read the detailed description
The purpose of this study is to evaluate patients with tibial plateau fractures. The goal is to compare the differences between anteriorly placed (front of leg) femoral external fixator pins and laterally placed (side of leg) femoral external fixator pins.
Specifically, we are evaluating how this placement affects the quadriceps muscle and knee function. The parameters that will be assessed are knee function, pain, and range of motion.
- Conditions
- Fractures, Closed
- Being tested
- Anterior pin placement, Lateral pin placement
- Medical subject headings
- Fractures, Closed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior pin placementDevice
Anteriorly-placed (front of the leg) femoral external fixator pins
Lateral pin placementDevice
Laterally-placed (side of the leg) femoral external fixator pind
| Study group | Role | What they receive |
|---|---|---|
| Anterior pin placement | Experimental | Anterior pin placement Receives: Device: Anterior pin placement |
| Lateral pin placement | Experimental | Lateral pin placement Receives: Device: Lateral pin placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps Strength
measurement of quadriceps muscle strength at final followup = 1 year data at interim time points recorded, but only final reported for this purpose
Measured: (admission, 6 weeks, 3 months, 6 months) 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study startMar 2006
- Primary completionAug 2012
- Study completionFeb 2014
Why it stopped: Extremely low enrollment and very little follow-up for meaningful data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fractures, ClosedStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brett Crist, University of Missouri-Columbia
- Investigators
- Brett Crist, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610701
- Sponsor's protocol ID
- IRB 1059937
- Status last verified
- Jun 2017
- First submitted
- 25 Jan 2008
- Last updated
- 24 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures
- ClinicalTrials.gov ID
- NCT00610701
- Acronym / sponsor ID
- IRB 1059937
- Conditions
- Fractures, Closed
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Extremely low enrollment and very little follow-up for meaningful data
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Aug 2012 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 8 Feb 2008 (estimated)
- Results
- Posted 10 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate patients with tibial plateau fractures.
Detailed description
The purpose of this study is to evaluate patients with tibial plateau fractures. The goal is to compare the differences between anteriorly placed (front of leg) femoral external fixator pins and laterally placed (side of leg) femoral external fixator pins.
Specifically, we are evaluating how this placement affects the quadriceps muscle and knee function. The parameters that will be assessed are knee function, pain, and range of motion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior pin placement | Experimental | Device: Anterior pin placementAnterior pin placement |
| Lateral pin placement | Experimental | Device: Lateral pin placementLateral pin placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age and above (adult population)
- All open and closed tibial plateau fractures
Key exclusion criteria (5 listed)
- 17 years of age and less (pediatric population)
- Quadriplegic patients
- Vascular Injury to Extremity
- Ipsilateral femur fractures
- Ipsilateral Hip 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 |
|---|---|---|
| Anterior pin placementAnteriorly-placed (front of the leg) femoral external fixator pins | Device | Anterior pin placement |
| Lateral pin placementLaterally-placed (side of the leg) femoral external fixator pind | Device | Lateral pin placement |
Primary outcome
Quadriceps Strength
Time frame: (admission, 6 weeks, 3 months, 6 months) 1 year
measurement of quadriceps muscle strength at final followup = 1 year data at interim time points recorded, but only final reported for this purpose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Brett Crist, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior pin placement and Lateral pin placement in people with Fractures, Closed, run by University of Missouri-Columbia 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?
The sponsor lists 2 inclusion and 5 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 24 Jul 2017. 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?
Yes. Results are posted in the registry (first posted 10 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Quadriceps Strength (time frame: (admission, 6 weeks, 3 months, 6 months) 1 year). 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 24 Jul 2017.