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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Mohamed D Hamouda, resident contact

01009175859

mohameddeaa@med.sohag.edu.eg

Ahmed E Addosooki, professor contact

Egypt1 site, 1 recruiting
  • Sohag university Hospital

    Sohag

    Magdy M Amin, professor

    Recruiting

Other trials in Egypt

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 :

  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

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 groups in NCT06353048
Study groupRoleWhat they receive
group AActive comparatorpatients with tibial plateau fractures Schatzker type II fixed by screws only
Receives: Procedure: fixation of tibial plateau fractures
group BActive comparatorpatients 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.

  1. 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.

  1. First posted8 Apr 2024
  2. Study start10 Feb 2024
  3. Primary completion15 Feb 2025 (estimated)
  4. Study completion15 Feb 2025 (estimated)

Resources

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)
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 28461952
  • 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.

    PubMed 27876042
  • Giordano CP, Koval KJ, Zuckerman JD, Desai P. Fracture blisters. Clin Orthop Relat Res. 1994 Oct;(307):214-21.

    PubMed 7924035
  • 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.

    PubMed 9334949

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.

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