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

Completed

• Conditions: Recurrent Patellar Dislocation; Ligament; Laxity
• Interventions: Diagnostic Test: genetic test; Other: Beighton joint laxity test

• Registration Number: NCT05763108
• Lead Sponsor: Polish Mother Memorial Hospital Research Institute

Brief Summary

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.

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 Timeline

• Study Start: 2022-04-01
• Status Verified: 2022-10
• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-10
• Primary Completion: 2023-04-01
• Study Completion: 2023-12-20
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Recurrent patellar dislocation group	genetic test	50 patients with recurrent patellar dislocation and without any genetic disorders.
Recurrent patellar dislocation group	Beighton joint laxity test	50 patients with recurrent patellar dislocation and without any genetic disorders.
Patients without joint hipermobility	genetic test	200 patients without recurrent patellar dislocation and genetic disorders.
Patients without joint hipermobility	Beighton joint laxity test	200 patients without recurrent patellar dislocation and genetic disorders.

Primary Outcome Measures

Name	Time	Method
Patients with recurrent patellar dislocation	2022-2023	Patients with recurrent patellar dislocation
Control group without obvious joint hipermobility	2022-2023	Control group without obvious joint hipermobility

Trial Locations

Locations (1)

Krzysztof Małecki; 🇵🇱 Łódź, Lodzkie Voivodeship, Poland