Management Of Patellar Fractures By Craniofacial Mesh Plate Osteosynthesis Augmented by Screws

January 4, 2024 updated by: Ayman Atef Ahmed, Sohag University

Patellar fractures are challenging orthopedic injuries. Fractures that result in disruption of the extensor mechanism led to significant functional deficits. The goals of treatment for patella fractures include restoration of articular congruity, painless full range of motion of the knee, and recovery of extensor mechanism function.

The biomechanical construct chosen to fix patellar fractures is very important because of the subcutaneous location of the patella and the high level of force transmission that occurs through the patella during flexion and extension of the knee. Some studies have shown that during specific actions like walking or climbing downhill, the patella can see forces as high as 3200 N, equaling four to five times the standard body weight of a person. Achieving biomechanical stability during patellar fracture fixation is imperative as the stability of fixation is tested thousands of times as the knee is put through numerous cycles of flexion and extension during the recovery period. While tension band wiring with or without -K- wire, screw, or cerclage wire augmentation the most widely accepted form of treatment for patellar fractures, plate osteosynthesis is gaining popularity for certain fracture patterns. We present below a novel form of patellar fracture fixation using MatrixNEURO Contourable Mesh plates (Synthes®). Made of titanium with an incredibly low profile, these plates were initially designed for use in midface and craniofacial skeletal trauma.

However, we found that using these plates in treatment of patellar fractures has allowed stable fixation of complex, severely comminuted injuries The benefit of plate is adequate and stable reduction and maintenance of this reduction

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Elshazly S Mousa, professor
  • Phone Number: 01223856260

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag University Hospital
        • Contact:
          • Magdy M Amin, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

patient with simple patella fractues more than 16 years.

Exclusion Criteria:

  • Open fractures
  • Preexisting deformity
  • Ipsilateral femoral injuries

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patient group
patients more than 16 years old with patella frature
Procedure: fixation of patella fractures by craniofacial mesh plate osteosynthesis augmented by screws
patellar fracture fixation using MatrixNEURO Contourable Mesh plates (Synthes®). Made of titanium with an incredibly low profile
Other Names:
  • patella plate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adequate and stable reduction
Time Frame: 1 year
Evaluation of results of fixation of patellar fractures by craniofacial mesh plate
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

January 4, 2024

First Submitted That Met QC Criteria

January 4, 2024

First Posted (Estimated)

January 15, 2024

Study Record Updates

Last Update Posted (Estimated)

January 15, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-23-12-11MS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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