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Association of SNPs in Metalloproteinases (MMPs) Genes With the Risk of Primary Knee Osteoarthritis in Greek Population.

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ClinicalTrials.gov Identifier: NCT04463290
Recruitment Status : Not yet recruiting
First Posted : July 9, 2020
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
Christos Milaras, Aristotle University Of Thessaloniki

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?

Condition or disease Intervention/treatment
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 Other: No intervention, Patients selection based on clinical symptoms and radiological imaging

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 includ 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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Association of Single Nucleotide Polymorphisms in Metalloproteinases (MMPs) Genes With the Risk of Primary Knee Osteoarthritis in Greek Population.
Estimated Study Start Date : July 6, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Knee Osteoarthritis Patients Group
Patients suffering from primary knee osteoarthritis
Other: No intervention, Patients selection based on clinical symptoms and radiological imaging
No intervention

Control Group
Healthy people without suffering from primary knee osteoarthritis
Other: No intervention, Patients selection based on clinical symptoms and radiological imaging
No intervention




Primary Outcome Measures :
  1. The frequensy 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 [ Time Frame: 6 months ]

Biospecimen Retention:   Samples With DNA
2ml blood


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04463290


Contacts
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Contact: Christos Milaras, Phd Cand. +306942267715 mil1384@yahoo.gr
Contact: Eleftherios Tsiridis, Professor +302313323702 g.orthop@gmail.com

Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
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Study Director: Eleftherios Tsiridis, Professor Aristotle University of Thessaloniki, 3rd Orthopaedic Department, Medical School
Publications:

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Responsible Party: Christos Milaras, Orthopaedic Surgeon, Phd Candidate, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT04463290    
Other Study ID Numbers: 197/17.6.2020
First Posted: July 9, 2020    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data that will be shared will be all the demographic data of the participants (gender, age, etc.) and the study results data. Personal participants data as name, adress, telephone number will not be shared for any reason.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 12 months after publication
Access Criteria: Investigators from Greece, after personal contact.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christos Milaras, Aristotle University Of Thessaloniki:
MMPs , SNPs, Knee osteoarthritis, -1575G/A MMP-2 , 836A/G MMP-9 , -77A/G MMP-13
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases