Tibial FractureNCT02035917
Comparison of Tibial Plateau Fractures Outcomes Treated With Non-locking and Locking Plate
A study testing Locking plate and Non-Locking plate in people with Tibial Fracture, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
this study will perform to compare the results and functional outcomes of tibial plateau fractures treated with non-locking and locking plate fixation. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Tibial Fracture
- What is being tested?
- Locking plate and Non-Locking plate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- Start not givento Apr 2014
- 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 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- unilateral closed tibia plateau fracture
Who cannot join
- patients who have been treated with casting or screw
- history of diabetes mellitus
- evidences of pathological fractures
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Vice Chancellery for Research of Isfahan University of Medical Sciences, Isfahan, Iran
Isfahan, Isfahan, 8174673461
Amin Nemati, Orthopedic surgery resident
About this study
this study will perform to compare the results and functional outcomes of tibial plateau fractures treated with non-locking and locking plate fixation.
- Conditions
- Tibial Fracture
- Being tested
- Locking plate, Non-Locking plate
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locking plateDevice
Non-Locking plateDevice
| Study group | Role | What they receive |
|---|---|---|
| Locking plate | Experimental | Not described Receives: Device: Locking plate |
| Non-Locking plate | Active comparator | Not described Receives: Device: Non-Locking plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
knee society knee score
Measured: ten months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Primary completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial 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
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amin Nemati, Isfahan University of Medical Sciences
- Investigators
- Mohammad Ali Tahririan, Orthopedic surgeon, Study director, Department of Orthopedics, Kashani hospital, Isfahan University of Medical sciences, Isfahan, IranMohsen Derakhshan, Orthopedic surgery resident, Principal investigator, Department of Orthopedics, Kashani hospital, Isfahan University of Medical sciences, Isfahan, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035917
- Sponsor's protocol ID
- 392120
- Status last verified
- Jan 2014
- First submitted
- 11 Jan 2014
- Last updated
- 14 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Tibial Plateau Fractures Outcomes Treated With Non-locking and Locking Plate
- ClinicalTrials.gov ID
- NCT02035917
- Acronym / sponsor ID
- 392120
- Conditions
- Tibial Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Primary completion
- Apr 2014 (estimated)
- First posted
- 14 Jan 2014 (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.
this study will perform to compare the results and functional outcomes of tibial plateau fractures treated with non-locking and locking plate fixation.
Study design
- Primary purpose
- Treatment
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Locking plate | Experimental | Device: Locking plate |
| Non-Locking plate | Active comparator | Device: Non-Locking plate |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- unilateral closed tibia plateau fracture
Key exclusion criteria (3 listed)
- patients who have been treated with casting or screw
- history of diabetes mellitus
- evidences of pathological 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 |
|---|---|---|
| Locking plate | Device | Locking plate |
| Non-Locking plate | Device | Non-Locking plate |
Primary outcome
knee society knee score
Time frame: ten months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
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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.
Mohammad Ali Tahririan, Orthopedic surgeon study director
Department of Orthopedics, Kashani hospital, Isfahan University of Medical sciences, Isfahan, Iran
Mohsen Derakhshan, Orthopedic surgery resident principal investigator
Department of Orthopedics, Kashani hospital, Isfahan University of Medical sciences, Isfahan, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Locking plate and Non-Locking plate in people with Tibial Fracture, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 3 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 14 Jan 2014. 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 Iran. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amin Nemati, Orthopedic surgery resident (00989131009918, nemati@med.mui.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knee society knee score (time frame: ten months after surgery). 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 14 Jan 2014.