Open tíbia FractureNCT04072094
Minimally Invasive Locking Plate Fixation vs Reamed Intramedullary Nail Fixation on Patients With Open Tibia Fracture
A study testing Minimally Invasive Locking Plate Fixation and Intramedullary Nail Fixation in people with Open tíbia Fracture, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
The best treatment for the open tibia fractures remains controversial. It is unknown whether minimally invasive locking plate or reamed intramedullary nail fixation will result in lower complication rates and better function. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Open tíbia Fracture
- What is being tested?
- Minimally Invasive Locking Plate Fixation and Intramedullary Nail Fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jun 2020to Jun 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ages 18 - 60 years inclusive
- Open diaphyseal fracture
- Gustilo-Anderson Type I, II, IIIA
Who cannot join
- Closed, periarticular or pathological fracture
- Gustilo-Anderson Type IIIB,IIIC
- Patients with concomitant fractures in the ipsilateral limb
- The patient is unable to medically tolerate general anesthesia
- The patient is unable to provide informed consent or comply with completing questionnaires
- Tibia already infected as diagnosed by a surgeon
- The patient has been diagnosed with a severe psychiatric condition
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective Randomized Trial Comparing the Effect of Minimally Invasive Locking Plate Fixation and Reamed Intramedullary Nail Fixation on Patients With Gustilo I-III A Open Tibia Fracture
The best treatment for the open tibia fractures remains controversial. It is unknown whether minimally invasive locking plate or reamed intramedullary nail fixation will result in lower complication rates and better function.
Read the detailed description
The best fixation method for open tibial fractures remains controversial. The current standard treatment options recommended the use of intramedullary nail for treating such fractures. Recent studies also showed favorable results for the use of plates in managing open tibial fractures. However, it is unknown whether locking plate or intramedullary nail fixation will result in lower complication rates and better function.
This study is a prospective, randomized trial to compare the safety and efficiency of minimally invasive plate osteosynthesis and reamed intramedullary nails in treating type I-II open tibial shaft fractures. The investigators hypothesize that neither intervention resulted in a superior disability rating at 12 months. Outcomes evaluated will include the rate of infection, the number of re-hospitalization for the complication, the time to bone healing, Patient-Reported outcome and quality of life and other complications.
- Conditions
- Open tíbia Fracture
- Being tested
- Minimally Invasive Locking Plate Fixation, Intramedullary Nail Fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive Locking Plate FixationProcedure or surgery
Also called Locking Plate Fixation
Patients randomized to the Minimally Invasive Locking Plate Fixation arm will be treated with plate fixation. The plate may be applied in a percutaneous fashion. Any combination of locked and/or non-locked screws may be used.
Intramedullary Nail FixationProcedure or surgery
Patients randomized to the Intramedullary Nail Fixation arm will be receive a standard locked intramedullary nail fixation. The nail must use at least one static interlock proximal to and one static interlock distal to the fracture site. The nail may be placed with a reamed technique.
| Study group | Role | What they receive |
|---|---|---|
| Minimally Invasive Locking Plate Fixation | Experimental | Patients randomized to the Minimally Invasive Locking Plate Fixation arm will be treated with plate fixation. The plate may be applied in a percutaneous fashion. Any combination of locked and/or non-locked screws may be used. Receives: Procedure: Minimally Invasive Locking Plate Fixation |
| Intramedullary Nail Fixation | Active comparator | Patients randomized to the Intramedullary Nail Fixation arm will be receive a standard locked intramedullary nail fixation. The nail must use at least one static interlock proximal to and one static interlock distal to the fracture site. The nail may be placed with a reamed technique. Receives: Procedure: Intramedullary Nail Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
LEFS
failure.
Measured: 12 months
Secondary outcomes (1)
EQ-5D
Reported Outcome and Quality of Life
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study startJun 2020 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open tíbia FractureStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Taizhou Hospital, Ningbo No.2 Hospital, The First People's Hospital of Huzhou
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072094
- Sponsor's protocol ID
- z2gk
- Status last verified
- Aug 2019
- First submitted
- 19 Aug 2019
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Comparing the Effect of Minimally Invasive Locking Plate Fixation and Reamed Intramedullary Nail Fixation on Patients With Gustilo I-III A Open Tibia Fracture
- ClinicalTrials.gov ID
- NCT04072094
- Acronym / sponsor ID
- z2gk
- Conditions
- Open tíbia Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Taizhou Hospital, Ningbo No.2 Hospital, The First People's Hospital of Huzhou
- Study start
- Jun 2020 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 28 Aug 2019 (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.
The best treatment for the open tibia fractures remains controversial. It is unknown whether minimally invasive locking plate or reamed intramedullary nail fixation will result in lower complication rates and better function.
Detailed description
The best fixation method for open tibial fractures remains controversial. The current standard treatment options recommended the use of intramedullary nail for treating such fractures. Recent studies also showed favorable results for the use of plates in managing open tibial fractures. However, it is unknown whether locking plate or intramedullary nail fixation will result in lower complication rates and better function.
This study is a prospective, randomized trial to compare the safety and efficiency of minimally invasive plate osteosynthesis and reamed intramedullary nails in treating type I-II open tibial shaft fractures. The investigators hypothesize that neither intervention resulted in a superior disability rating at 12 months. Outcomes evaluated will include the rate of infection, the number of re-hospitalization for the complication, the time to bone healing, Patient-Reported outcome and quality of life and other complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally Invasive Locking Plate Fixation | Experimental | Procedure: Minimally Invasive Locking Plate FixationPatients randomized to the Minimally Invasive Locking Plate Fixation arm will be treated with plate fixation. The plate may be applied in a percutaneous fashion. Any combination of locked and/or non-locked screws may be used. |
| Intramedullary Nail Fixation | Active comparator | Procedure: Intramedullary Nail FixationPatients randomized to the Intramedullary Nail Fixation arm will be receive a standard locked intramedullary nail fixation. The nail must use at least one static interlock proximal to and one static interlock distal to the fracture site. The nail may be placed with a reamed technique. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ages 18 - 60 years inclusive
- Open diaphyseal fracture
- Gustilo-Anderson Type I, II, IIIA
Key exclusion criteria (7 listed)
- Closed, periarticular or pathological fracture
- Gustilo-Anderson Type IIIB,IIIC
- Patients with concomitant fractures in the ipsilateral limb
- The patient is unable to medically tolerate general anesthesia
- The patient is unable to provide informed consent or comply with completing questionnaires
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 |
|---|---|---|
| Minimally Invasive Locking Plate FixationAlso: Locking Plate FixationPatients randomized to the Minimally Invasive Locking Plate Fixation arm will be treated with plate fixation. The plate may be applied in a percutaneous fashion. Any combination of locked and/or non-locked screws may be used. | Procedure or surgery | Minimally Invasive Locking Plate Fixation |
| Intramedullary Nail FixationPatients randomized to the Intramedullary Nail Fixation arm will be receive a standard locked intramedullary nail fixation. The nail must use at least one static interlock proximal to and one static interlock distal to the fracture site. The nail may be placed with a reamed technique. | Procedure or surgery | Intramedullary Nail Fixation |
Primary outcome
LEFS
Time frame: 12 months
failure.
1 secondary outcome
EQ-5D
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 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 Minimally Invasive Locking Plate Fixation and Intramedullary Nail Fixation in people with Open tíbia Fracture, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 12 May 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 Zhao-ming Ye, MD (+86-571-87783553, 2192002@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LEFS (time frame: 12 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 12 May 2020.