Clinical Significance and Coexistence of Polymorphisms of Individual Collagen-coding Genes

April 3, 2024 updated by: Polish Mother Memorial Hospital Research Institute

Clinical Significance and Coexistence of Polymorphisms of Individual Collagen-coding Genes - rs1800012 of the COL1A1 Gene and rs12722 of the COL5A1 Gene in Patellar Instability in Children.

The purpose of this study is to assess correlation between recurrent patella dislocation and genetic polymorphism rs1800012 of the COL1A1 Gene and rs12722 of the COL5A1 Gene.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After being informed about the study and potential risk all of participants were performed phisical examination and genetic test. In the study we established two groups: In first group- 50 patients with recurrent patellar dislocation and without any genetic disorders. In the second one 200 patients without recurrent patellar dislocation and genetic disorders. All pediatric patients were between 7 and 17 years old in two groups respectivly.

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

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

Study Locations

  • Poland
    • Lodzkie Voivodeship
      • Lodz, Lodzkie Voivodeship, Poland, 93-338
        • Krzysztof Małecki
      • Łódź, Lodzkie Voivodeship, Poland, 93-160
        • Krzysztof Małecki

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

7 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients between 7 and 17 years old with recurrent dislocation of the patella without genetic diseases.

Description

Inclusion Criteria:

• First-time diagnosed or recurrent patellar dislocation patient from 7 to 17 age years old.

Exclusion Criteria:

  • Patient's age under 7.
  • Presence of genetic diseases such as: Down's syndrome or Marfan's syndrome.
  • Metabolic disorders.
  • Previous knee surgeries.
  • Cartilage and bone fractures in the knee.
  • No consent for examination from the legal guardian.

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
Recurrent patellar dislocation group
50 patients with recurrent patellar dislocation and without any genetic disorders.
Diagnostic test: genetic test
COL1A1 or COL5A1 genetic test
Other: Beighton joint laxity test
Based on Beighton scale.
Patients without joint hipermobility
200 patients without recurrent patellar dislocation and genetic disorders.
Diagnostic test: genetic test
COL1A1 or COL5A1 genetic test
Other: Beighton joint laxity test
Based on Beighton scale.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients with recurrent patellar dislocation
Time Frame: 2022-2023
Patients with recurrent patellar dislocation
2022-2023
Control group without obvious joint hipermobility
Time Frame: 2022-2023
Control group without obvious joint hipermobility
2022-2023

Collaborators and Investigators

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

Sponsor

Polish Mother Memorial Hospital Research Institute

Investigators

  • Principal Investigator: Krzysztof Małecki, PMMHRI

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)

April 1, 2022

Primary Completion (Actual)

April 1, 2023

Study Completion (Actual)

December 20, 2023

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 10, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMMHRI-2021.2/1/7-GW

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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