Patella FracturePhase 1NCT06205914
Management Of Patellar Fractures By Craniofacial Mesh Plate Osteosynthesis Augmented by Screws
A Phase 1 study testing fixation of patella fractures by craniofacial mesh plate osteosynthesis augmented by screws in people with Patella Fracture, run by Sohag University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Patella Fracture
- What is being tested?
- fixation of patella fractures by craniofacial mesh plate osteosynthesis augmented by screws
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to Aug 2024
- Phase
- Phase 1
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patient with simple patella fractues more than 16 years.
Who cannot join
- Open fractures
- Preexisting deformity
- Ipsilateral femoral injuries
Trial locations and contacts
1 site in 1 country.
Elshazly S Mousa, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag
Magdy M Amin, professor
About this study
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
- Conditions
- Patella Fracture
- Being tested
- fixation of patella fractures by craniofacial mesh plate osteosynthesis augmented by screws
- Medical subject headings
- Patella Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fixation of patella fractures by craniofacial mesh plate osteosynthesis augmented by screwsProcedure or surgery
Also called patella plate
patellar fracture fixation using MatrixNEURO Contourable Mesh plates (Synthes®). Made of titanium with an incredibly low profile
| Study group | Role | What they receive |
|---|---|---|
| patient group | Experimental | patients more than 16 years old with patella frature Receives: Procedure: fixation of patella fractures by craniofacial mesh plate osteosynthesis augmented by screws |
What is being measured
The primary outcome is the main question the study is designed to answer.
adequate and stable reduction
Evaluation of results of fixation of patellar fractures by craniofacial mesh plate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start1 Jan 2024
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Patella FractureStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Atef Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205914
- Sponsor's protocol ID
- Soh-Med-23-12-11MS
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2024
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26816667Benjamin 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.
PubMed 3506054Siljander 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.
PubMed 29381883Volgas 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.
PubMed 28192827
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management Of Patellar Fractures By Craniofacial Mesh Plate Osteosynthesis Augmented by Screws
- ClinicalTrials.gov ID
- NCT06205914
- Acronym / sponsor ID
- Soh-Med-23-12-11MS
- Conditions
- Patella Fracture
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient group | Experimental | Procedure: fixation of patella fractures by craniofacial mesh plate osteosynthesis augmented by screwspatients more than 16 years old with patella frature |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- patient with simple patella fractues more than 16 years.
Key exclusion criteria (3 listed)
- Open fractures
- Preexisting deformity
- Ipsilateral femoral injuries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fixation of patella fractures by craniofacial mesh plate osteosynthesis augmented by screwsAlso: patella platepatellar fracture fixation using MatrixNEURO Contourable Mesh plates (Synthes®). Made of titanium with an incredibly low profile | Procedure or surgery | patient group |
Primary outcome
adequate and stable reduction
Time frame: 1 year
Evaluation of results of fixation of patellar fractures by craniofacial mesh plate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Background: PubMed 26816667Gwinner 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.
- Background: PubMed 3506054Benjamin 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.
- Background: PubMed 29381883Siljander 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.
- Background: PubMed 28192827Volgas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elshazly S Mousa, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing fixation of patella fractures by craniofacial mesh plate osteosynthesis augmented by screws in people with Patella Fracture, 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 1 inclusion and 3 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 16 Jan 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ayman A AboGabal, resident (01014464351, aymanatef@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adequate and stable reduction (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 NCT06205914, 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 16 Jan 2024.