Short Term Radiological and Clinical Outcomes of Fixation of Schatzker II Tibial Plateau Fractures by Screws Only Versus Plate and Screws , Comparative Study

NCT ID: NCT06353048

Last Updated: 2024-04-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-10
• Study Completion Date: 2025-02-15

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 (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 :

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

Conditions

Tibial Plateau Fractures Schatzker Type II

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group A

patients with tibial plateau fractures Schatzker type II fixed by screws only

Group Type: ACTIVE_COMPARATOR

fixation of tibial plateau fractures

Intervention Type: PROCEDURE

fixation of tibial plateau fractures by screws only versus plate and screws

group B

patients with tibial plateau fractures Schatzker type II fixed by plate and screws

Group Type: ACTIVE_COMPARATOR

fixation of tibial plateau fractures

Intervention Type: PROCEDURE

fixation of tibial plateau fractures by screws only versus plate and screws

Interventions

fixation of tibial plateau fractures

fixation of tibial plateau fractures by screws only versus plate and screws

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• skeletally mature patients aging 18 to 70 years .
• Patient with type II (split depression of lateral tibial plateau )

Exclusion Criteria

• Severe comminution with >5 mm depression,
• Open fractures,

• Compartment syndrome, or
• Vascular injury

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Diaaeldin Hamouda

Resident of Orthopaedic department, Sohag University Hospitals

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag university Hospital

Sohag, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamed D Hamouda, resident

Role: CONTACT

mohameddeaa@med.sohag.edu.eg

01009175859

Ahmed E Addosooki, professor

Role: CONTACT

Facility Contacts

Magdy M Amin, professor

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 28461952 (View on PubMed)

Salduz 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.

Reference Type: BACKGROUND

PMID: 27876042 (View on PubMed)

Giordano CP, Koval KJ, Zuckerman JD, Desai P. Fracture blisters. Clin Orthop Relat Res. 1994 Oct;(307):214-21.

Reference Type: BACKGROUND

PMID: 7924035 (View on PubMed)

Chan 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.

Reference Type: BACKGROUND

PMID: 9334949 (View on PubMed)

Other Identifiers

Soh-Med-24-02-04MS

Identifier Type: -

Identifier Source: org_study_id