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

August 17, 2022 updated by: Christos Milaras, Aristotle University Of Thessaloniki
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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Christos Milaras, Phd Cand.
  • Phone Number: +306942267715
  • Email: mil1384@yahoo.gr

Study Contact Backup

  • Name: Eleftherios Tsiridis, Professor
  • Phone Number: +302313323702
  • Email: g.orthop@gmail.com

Study Locations

  • Greece
    • Athens
      • Thessaloníki, Athens, Greece, 56403
        • Recruiting
        • 3rd Orthopedic Department , Pagageorgiou Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Investigators

  • Study Director: Eleftherios Tsiridis, Professor, Aristotle University of Thessaloniki, 3rd Orthopaedic Department, Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 6, 2020

Primary Completion (ANTICIPATED)

November 28, 2022

Study Completion (ANTICIPATED)

December 30, 2022

Study Registration Dates

First Submitted

July 5, 2020

First Submitted That Met QC Criteria

July 5, 2020

First Posted (ACTUAL)

July 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 17, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 197/17.6.2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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, address, telephone number will not be shared for any reason.

IPD Sharing Time Frame

12 months after publication

IPD Sharing Access Criteria

Investigators from Greece, after personal contact.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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