Tibial Plateau Fractures Schatzker Type IINCT06353048
Short Term Radiological and Clinical Outcomes of Fixation of Schatzker II Tibial Plateau Fractures by Screws Only Versus Plate and Screws , Comparative Study
A study testing fixation of tibial plateau fractures in people with Tibial Plateau Fractures Schatzker Type II, run by Sohag University at 1 site in Egypt.
Trial summary
Tibial plateau fractures are complex injuries produced by high- or low-energy trauma. They principally affect young adults or the 'third age' population ,the tibial plateau is a major weight-bearing surface within the largest and most kinematically complex joint in the human body. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tibial Plateau Fractures Schatzker Type II
- What is being tested?
- fixation of tibial plateau fractures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2024to 15 Feb 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- skeletally mature patients aging 18 to 70 years .
- Patient with type II (split depression of lateral tibial plateau )
Who cannot join
- Severe comminution with >5 mm depression,
- Open fractures,
- Compartment syndrome, or
- Vascular injury
Trial locations and contacts
1 site in 1 country.
Ahmed E Addosooki, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag
Magdy M Amin, professor
About this study
Tibial plateau fractures are complex injuries produced by high- or low-energy trauma. They principally affect young adults or the 'third age' population ,the tibial plateau is a major weight-bearing surface within the largest and most kinematically complex joint in the human body. Fractures occur as a result of a combination of an axial loading force and a coronal plane (varus/valgus) moment leading to articular shear and depression and mechanical axis malalignment,So Limb alignment and articular surface restoration, allowing early knee motion, are the main goals of surgical treatment.
Soft-tissue damage in fractures around the knee is of critical importance. The oedema and inflammation associated with the trauma can easily lead to local venous compromise, dermal hypoxia, and additional soft-tissue injury. This commonly leads to blistering of the skin and in some cases dermal and even muscle necrosis. Blood-filled blisters should be expected to be associated with a worse outcome than clear fluid-filled ones. Management in the early stages of treatment should focus on preventing further soft-tissue injury while waiting to repair the fracture.
Read more
Traditionally, initial radiograph diagnosis should include anteroposterior (AP), lateral and oblique views. But single radiographs do not allow an exact fragment identification and the initial fracture classification can change in 5% to 24% (mean 12%) of cases and treatment can change in up to 26% of cases after CT scan imaging . These findings and the wider availability of CT scanning have made the oblique views less important in the diagnosis. Intra- and peri-articular soft-tissue structures can be affected even in less complex fracture patterns and some X-ray or CT scan data can also suggest the existence of a lateral or medial meniscal tear. Articular depression > 6 mm and/or articular widening > 5 mm are associated with the existence of lateral meniscus, lateral collateral ligament (LCL) or posterior cruciate ligament injuries .
Schatzer classification (published in 1974) will be used to complete understanding of the personality of these fracture which is the key element in decision making process when choosing the best possible treatment .
In general ,tibial plateau fracture are to be operated on , but the decision whether to be operated or not on a specific fracture should be based on the fracture morphology ,soft tissues , the patient general condition and the expected limb axis and articular surface restoration.
Usual indications for surgical treatment are :
- Intra-articular displacement of ⩾ 2 mm
- Metaphyseal -diaphyseal translation > 1 cm
- Angular deformity more than 10 degree in the coronal or sagittal view
- Open fracture , compartment syndrome and associated ligament injury require repair.
- Associated fractures of the ipsilateral tibia or fibula
Frequently the depressed articular fragments have to elevated back toward the knee , followed by fixation and sometimes supplemented with bone graft to fill any cancellous bone voids left beneath the joint surface after fracture reduction .
We will evaluate treatment outcomes of closed reduction and percutaneous cannulated screw fixation for tibial plateau fractures versus open reduction and fixation by plate
- Being tested
- fixation of tibial plateau fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fixation of tibial plateau fracturesProcedure or surgery
fixation of tibial plateau fractures by screws only versus plate and screws
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | patients with tibial plateau fractures Schatzker type II fixed by screws only Receives: Procedure: fixation of tibial plateau fractures |
| group B | Active comparator | patients with tibial plateau fractures Schatzker type II fixed by plate and screws Receives: Procedure: fixation of tibial plateau fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
range of motion of knee joint using Rasmussen score
The primary oucome that we like to measure is range of motion of knee joint on flexion and extension of the joint .
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 posted8 Apr 2024
- Study start10 Feb 2024
- Primary completion15 Feb 2025 (estimated)
- Study completion15 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tibial Plateau Fractures Schatzker Type IIStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Diaaeldin Hamouda, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353048
- Sponsor's protocol ID
- Soh-Med-24-02-04MS
- Status last verified
- Apr 2024
- First submitted
- 17 Mar 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Prat-Fabregat S, Camacho-Carrasco P. Treatment strategy for tibial plateau fractures: an update. EFORT Open Rev. 2017 Mar 13;1(5):225-232. doi: 10.1302/2058-5241.1.000031. eCollection 2016 May.
PubMed 28461952Salduz A, Birisik F, Polat G, Bekler B, Bozdag E, Kilicoglu O. The effect of screw thread length on initial stability of Schatzker type 1 tibial plateau fracture fixation: a biomechanical study. J Orthop Surg Res. 2016 Nov 22;11(1):146. doi: 10.1186/s13018-016-0484-9.
PubMed 27876042Giordano CP, Koval KJ, Zuckerman JD, Desai P. Fracture blisters. Clin Orthop Relat Res. 1994 Oct;(307):214-21.
PubMed 7924035Chan PS, Klimkiewicz JJ, Luchetti WT, Esterhai JL, Kneeland JB, Dalinka MK, Heppenstall RB. Impact of CT scan on treatment plan and fracture classification of tibial plateau fractures. J Orthop Trauma. 1997 Oct;11(7):484-9. doi: 10.1097/00005131-199710000-00005.
PubMed 9334949
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Radiological and Clinical Outcomes of Fixation of Schatzker II Tibial Plateau Fractures by Screws Only Versus Plate and Screws , Comparative Study
- ClinicalTrials.gov ID
- NCT06353048
- Acronym / sponsor ID
- Soh-Med-24-02-04MS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Feb 2024 (actual)
- Primary completion
- 15 Feb 2025 (estimated)
- Study completion
- 15 Feb 2025 (estimated)
- First posted
- 8 Apr 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.
Tibial plateau fractures are complex injuries produced by high- or low-energy trauma. They principally affect young adults or the 'third age' population ,the tibial plateau is a major weight-bearing surface within the largest and most kinematically complex joint in the human body. Fractures occur as a result of a combination of an axial loading force and a coronal plane (varus/valgus) moment leading to articular shear and depression and mechanical axis malalignment,So Limb alignment and articular surface restoration, allowing early knee motion, are the main goals of surgical treatment.
Soft-tissue damage in fractures around the knee is of critical importance. The oedema and inflammation associated with the trauma can easily lead to local venous compromise, dermal hypoxia, and additional soft-tissue injury. This commonly leads to blistering of the skin and in some cases dermal and even muscle necrosis. Blood-filled blisters should be expected to be associated with a worse outcome than clear fluid-filled ones. Management in the early stages of treatment should focus on preventing further soft-tissue injury while waiting to repair the fracture.
Traditionally, initial radiograph diagnosis should include anteroposterior (AP), lateral and oblique views. But single radiographs do not allow an exact fragment identification and the initial fracture classification can change in 5% to 24% (mean 12%) of cases and treatment can change in up to 26% of cases after CT scan imaging . These findings and the wider availability of CT scanning have made the oblique views less important in the diagnosis. Intra- and peri-articular soft-tissue structures can be affected even in less complex fracture patterns and some X-ray or CT scan data can also suggest the existence of a lateral or medial meniscal tear. Articular depression > 6 mm and/or articular widening > 5 mm are associated with the existence of lateral meniscus, lateral collateral ligament (LCL) or posterior cruciate ligament injuries .
Schatzer classification (published in 1974) will be used to complete understanding of the personality of these fracture which is the key element in decision making process when choosing the best possible treatment .
In general ,tibial plateau fracture are to be operated on , but the decision whether to be operated or not on a specific fracture should be based on the fracture morphology ,soft tissues , the patient general condition and the expected limb axis and articular surface restoration.
Usual indications for surgical treatment are :
- Intra-articular displacement of ⩾ 2 mm
- Metaphyseal -diaphyseal translation > 1 cm
- Angular deformity more than 10 degree in the coronal or sagittal view
- Open fracture , compartment syndrome and associated ligament injury require repair.
- Associated fractures of the ipsilateral tibia or fibula
Frequently the depressed articular fragments have to elevated back toward the knee , followed by fixation and sometimes supplemented with bone graft to fill any cancellous bone voids left beneath the joint surface after fracture reduction .
We will evaluate treatment outcomes of closed reduction and percutaneous cannulated screw fixation for tibial plateau fractures versus open reduction and fixation by plate
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Procedure: fixation of tibial plateau fracturespatients with tibial plateau fractures Schatzker type II fixed by screws only |
| group B | Active comparator | Procedure: fixation of tibial plateau fracturespatients with tibial plateau fractures Schatzker type II fixed by plate and screws |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- skeletally mature patients aging 18 to 70 years .
- Patient with type II (split depression of lateral tibial plateau )
Key exclusion criteria (4 listed)
- Severe comminution with >5 mm depression,
- Open fractures,
- Vascular injury
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 |
|---|---|---|
| fixation of tibial plateau fracturesfixation of tibial plateau fractures by screws only versus plate and screws | Procedure or surgery | group A, group B |
Primary outcome
range of motion of knee joint using Rasmussen score
Time frame: 1 year
The primary oucome that we like to measure is range of motion of knee joint on flexion and extension of the joint .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Background: PubMed 28461952Prat-Fabregat S, Camacho-Carrasco P. Treatment strategy for tibial plateau fractures: an update. EFORT Open Rev. 2017 Mar 13;1(5):225-232. doi: 10.1302/2058-5241.1.000031. eCollection 2016 May.
- Background: PubMed 27876042Salduz A, Birisik F, Polat G, Bekler B, Bozdag E, Kilicoglu O. The effect of screw thread length on initial stability of Schatzker type 1 tibial plateau fracture fixation: a biomechanical study. J Orthop Surg Res. 2016 Nov 22;11(1):146. doi: 10.1186/s13018-016-0484-9.
- Background: PubMed 7924035Giordano CP, Koval KJ, Zuckerman JD, Desai P. Fracture blisters. Clin Orthop Relat Res. 1994 Oct;(307):214-21.
- Background: PubMed 9334949Chan PS, Klimkiewicz JJ, Luchetti WT, Esterhai JL, Kneeland JB, Dalinka MK, Heppenstall RB. Impact of CT scan on treatment plan and fracture classification of tibial plateau fractures. J Orthop Trauma. 1997 Oct;11(7):484-9. doi: 10.1097/00005131-199710000-00005.
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.
Ahmed E Addosooki, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fixation of tibial plateau fractures in people with Tibial Plateau Fractures Schatzker Type II, run by Sohag University at 1 site in Egypt.
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 4 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 8 Apr 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 Egypt. 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 Mohamed D Hamouda, resident (01009175859, mohameddeaa@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
range of motion of knee joint using Rasmussen score (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06353048, which also lists 4 linked publications.
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 Apr 2024.