NCT06205914

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2024

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 16, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

January 16, 2024

Status Verified

January 1, 2024

Enrollment Period

7 months

First QC Date

January 4, 2024

Last Update Submit

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

EXPERIMENTAL

patients more than 16 years old with patella frature

Procedure: fixation of patella fractures by craniofacial mesh plate osteosynthesis augmented by screws

Interventions

patellar fracture fixation using MatrixNEURO Contourable Mesh plates (Synthes®). Made of titanium with an incredibly low profile

Also known as: patella plate
patient group

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

RECRUITING

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: 26816667BACKGROUND
  • 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.

    PMID: 3506054BACKGROUND
  • 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.

    PMID: 29381883BACKGROUND
  • 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.

    PMID: 28192827BACKGROUND

MeSH Terms

Conditions

Patella Fracture

Condition Hierarchy (Ancestors)

Knee FracturesFractures, BoneWounds and Injuries

Central Study Contacts

Ayman A AboGabal, resident

CONTACT

Elshazly S Mousa, professor

CONTACT

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

Locations