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

NCT ID: NCT05763108

Last Updated: 2024-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-12-20

Brief Summary

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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

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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.

Conditions

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Ligament; Laxity Recurrent Patellar Dislocation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Recurrent patellar dislocation group

50 patients with recurrent patellar dislocation and without any genetic disorders.

genetic test

Intervention Type DIAGNOSTIC_TEST

COL1A1 or COL5A1 genetic test

Beighton joint laxity test

Intervention Type OTHER

Based on Beighton scale.

Patients without joint hipermobility

200 patients without recurrent patellar dislocation and genetic disorders.

genetic test

Intervention Type DIAGNOSTIC_TEST

COL1A1 or COL5A1 genetic test

Beighton joint laxity test

Intervention Type OTHER

Based on Beighton scale.

Interventions

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genetic test

COL1A1 or COL5A1 genetic test

Intervention Type DIAGNOSTIC_TEST

Beighton joint laxity test

Based on Beighton scale.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Polish Mother Memorial Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Krzysztof Małecki

Role: PRINCIPAL_INVESTIGATOR

PMMHRI

Locations

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Krzysztof Małecki

Lodz, Lodzkie Voivodeship, Poland

Site Status

Krzysztof Małecki

Lodz, Lodzkie Voivodeship, Poland

Site Status

Countries

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Poland

Other Identifiers

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PMMHRI-2021.2/1/7-GW

Identifier Type: -

Identifier Source: org_study_id

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