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Completed

NCT Number: NCT05763108

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

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.

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Key information

Conditions

Ligament; Laxity Joint Diseases Joint Dislocations Joint Instability Knee Injuries Leg Injuries Musculoskeletal Diseases Patellar Dislocation Recurrent Patellar Dislocation Wounds and Injuries

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Krzysztof Małecki, Lodz, Lodzkie Voivodeship, Poland

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

genetic test

Diagnostic Test

COL1A1 or COL5A1 genetic test

Beighton joint laxity test

Other

Based on Beighton scale.

Primary outcomes

  1. Patients with recurrent patellar dislocation

    Time frame: 2022-2023

    Patients with recurrent patellar dislocation

  2. Control group without obvious joint hipermobility

    Time frame: 2022-2023

    Control group without obvious joint hipermobility

Sponsors and collaborators

Lead sponsor

Polish Mother Memorial Hospital Research Institute

Other

Registry information

Official study title

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.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 10, 2023
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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