Clinical trial NCT04463290: Association of Single Nucleotide Polymorphisms (SNPs) in Metalloproteinases (MMPs) Genes With the Risk of Primary Knee Osteoarthritis in Greek Population.
Official title: Association of Single Nucleotide Polymorphisms (SNPs) in Metalloproteinases (MMPs) Genes With the Risk of Primary Knee Osteoarthritis in Greek Population.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metalloproteinase SNPs -1575 G/A MMP-2, 836 A/G MMP-9 and -77 A/G MMP-13 and Risk for Developing Knee Osteoarthritis in Greek Population
Keywords: MMPs , SNPs, Knee osteoarthritis, -1575G/A MMP-2 , 836A/G MMP-9 , -77A/G MMP-13
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 200
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will take place at the 3rd Orthopedic Department of Aristotle University of Thessaloniki of the Papageorgiou General Hospital of Thessaloniki. The patients group will be patients with primary knee osteoarthritis coming for first examination for knee pain or for sceduled total knee arthroplasty surgery. The control group will be people coming for examination due to accident (trauma, fracture) or anything else not relevant with knee pain. Both groups must not have any of the exclusion criteria

Brief summary: Does the presence of gene polymorphisms -1575G / A in the MMP-2 gene, 836A / G in the MMP-9 gene and -77A / G in the MMP-13 gene, affect the risk of developing idiopathic knee osteoarthritis in the Greek population?

Detailed description: This is a prospective case-control study in which the patients' genotype will be studied against the genotype of the controls. The study is prospective and not retrospective, as data will be collected from patients with primary knee osteoarthritis as well as the control group from the outset. The study intends to include 200 people. The first group consists of 100 individuals suffering from knee osteoarthritis, while the second group will include 100 healthy controls without osteoarthritis. From each one DNA will be isolated and analyzed from collected blood. The prospective study allows valid data to be collected on patient demographics and disease severity. Due to the large number of cases of the disease, it is estimated that the necessary specimens will be collected within a reasonable time from the beginning of this thesis. The choice of the patient-control study is necessary to limit the influence of confounding factors (age, gender, obesity, etc.). This type of study includes rigorous selection of patients and controls with specific entry and exclusion criteria, selection of controls based on matching patient characteristics, stratification, and subgroup analyzes. The final result will be a comparison of the incidence of specific gene polymorphisms between patients with knee osteoarthritis and the normal population.

Eligibility criteria: Inclusion Criteria:

* Patients with primary knee osteoarthritis are selected based on clinical symptoms and radiological imaging with a score at least 2 on the Kellgren \& Lawrence scale.
* Patients without symptomatology or radiographic image of knee osteoarthritis (score \<2 on Kellgren \& Lawrence scale) will be selected as controls.

Exclusion Criteria:

* systemic inflammatory disease
* rheumatic disease
* liver disease
* renal failure
* neoplasm or other chronic disease

Primary outcomes:
measure: The frequency of presence of gene polymorphisms -1575G / A MMP-2 gene, 836A / G MMP-9 gene and -77A / G MMP-13 gene, in Greek patients with knee osteoarthritis comparing with healthy people
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: 3rd Orthopedic Department , Pagageorgiou Hospital
state: Athens
Study officials:
affiliation: Aristotle University of Thessaloniki, 3rd Orthopaedic Department, Medical School
name: Eleftherios Tsiridis, Professor
role: STUDY_DIRECTOR
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