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

Patella Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06205914
• Other study ID #: Soh-Med-23-12-11MS
• Status: Recruiting
• Phase: Phase 1
• Start date: January 1, 2024
• Est. completion date: August 2024

Study information

• Verified date: January 2024
• Source: Sohag University
• Contact: Ayman A AboGabal, resident
• Phone: 01014464351
• Email: aymanatef[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

Inclusion Criteria:

patient with simple patella fractues more than 16 years.

Exclusion Criteria:

• Open fractures

• Preexisting deformity

• Ipsilateral femoral injuries

Related Conditions & MeSH terms

• Fractures, Bone
• Patella Fracture

Intervention

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

Locations

Country	Name	City	State
Egypt	Sohag university Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Benjamin J, Bried J, Dohm M, McMurtry M. Biomechanical evaluation of various forms of fixation of transverse patellar fractures. J Orthop Trauma. 1987;1(3):219-22. doi: 10.1097/00005131-198701030-00004. — View Citation

Gwinner C, Mardian S, Schwabe P, Schaser KD, Krapohl BD, Jung TM. Current concepts review: Fractures of the patella. GMS Interdiscip Plast Reconstr Surg DGPW. 2016 Jan 18;5:Doc01. doi: 10.3205/iprs000080. eCollection 2016. — View Citation

Siljander M, Koueiter DM, Gandhi S, Wiater BP, Wiater PJ. Outcomes Following Low-Profile Mesh Plate Osteosynthesis of Patella Fractures. J Knee Surg. 2018 Oct;31(9):919-926. doi: 10.1055/s-0038-1625958. Epub 2018 Jan 30. — View Citation

Volgas D, Dreger TK. The Use of Mesh Plates for Difficult Fractures of the Patella. J Knee Surg. 2017 Mar;30(3):200-203. doi: 10.1055/s-0037-1598078. Epub 2017 Feb 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adequate and stable reduction	Evaluation of results of fixation of patellar fractures by craniofacial mesh plate	1 year