Management Of Patellar Fractures By Craniofacial Mesh Plate Osteosynthesis Augmented by Screws
1 other identifier
interventional
30
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2024
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2024
CompletedFirst Submitted
Initial submission to the registry
January 4, 2024
CompletedFirst Posted
Study publicly available on registry
January 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedJanuary 16, 2024
January 1, 2024
7 months
January 4, 2024
January 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
adequate and stable reduction
Evaluation of results of fixation of patellar fractures by craniofacial mesh plate
1 year
Study Arms (1)
patient group
EXPERIMENTALpatients more than 16 years old with patella frature
Interventions
patellar fracture fixation using MatrixNEURO Contourable Mesh plates (Synthes®). Made of titanium with an incredibly low profile
Eligibility Criteria
You may qualify if:
- patient with simple patella fractues more than 16 years.
You may not qualify if:
- Open fractures
- Preexisting deformity
- Ipsilateral femoral injuries
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sohag Universitylead
Study Sites (1)
Sohag university Hospital
Sohag, Egypt
Related Publications (4)
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.
PMID: 26816667BACKGROUNDBenjamin 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.
PMID: 3506054BACKGROUNDSiljander 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.
PMID: 29381883BACKGROUNDVolgas 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.
PMID: 28192827BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident-Orthopedic surgery depatement-Sohag university hospital
Study Record Dates
First Submitted
January 4, 2024
First Posted
January 16, 2024
Study Start
January 1, 2024
Primary Completion
August 1, 2024
Study Completion
August 1, 2024
Last Updated
January 16, 2024
Record last verified: 2024-01