Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353048
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-03-17
Brief Title:
Short Term Radiological and Clinical Outcomes of Fixation of Schatzker II Tibial Plateau Fractures by Screws Only Versus Plate and Screws Comparative Study
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Fractures occur as a result of a combination of an axial loading force and a coronal plane varusvalgus moment leading to articular shear and depression and mechanical axis malalignmentSo 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 andor 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
1 Intra-articular displacement of 2 mm
2 Metaphyseal -diaphyseal translation 1 cm
3 Angular deformity more than 10 degree in the coronal or sagittal view
4 Open fracture compartment syndrome and associated ligament injury require repair
5 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
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 andor 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
1 Intra-articular displacement of 2 mm
2 Metaphyseal -diaphyseal translation 1 cm
3 Angular deformity more than 10 degree in the coronal or sagittal view
4 Open fracture compartment syndrome and associated ligament injury require repair
5 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None