NCT05763108

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
Last Updated

April 4, 2024

Status Verified

October 1, 2022

Enrollment Period

1 year

First QC Date

February 28, 2023

Last Update Submit

April 3, 2024

Conditions

Ligament; LaxityRecurrent Patellar Dislocation

Outcome Measures

Primary Outcomes (2)

  • Patients with recurrent patellar dislocation

    Patients with recurrent patellar dislocation

    2022-2023

  • Control group without obvious joint hipermobility

    Control group without obvious joint hipermobility

    2022-2023

Study Arms (2)

Recurrent patellar dislocation group

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

Diagnostic Test: genetic testOther: Beighton joint laxity test

Patients without joint hipermobility

200 patients without recurrent patellar dislocation and genetic disorders.

Diagnostic Test: genetic testOther: Beighton joint laxity test

Interventions

genetic testDIAGNOSTIC_TEST

COL1A1 or COL5A1 genetic test

Patients without joint hipermobilityRecurrent patellar dislocation group
Beighton joint laxity testOTHER

Based on Beighton scale.

Patients without joint hipermobilityRecurrent patellar dislocation group

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Krzysztof Małecki

Lodz, Lodzkie Voivodeship, 93-160, Poland

Location

Krzysztof Małecki

Lodz, Lodzkie Voivodeship, 93-338, Poland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample or oral epithelial swab.

MeSH Terms

Conditions

Joint InstabilityPatellar Dislocation

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesJoint DislocationsWounds and InjuriesKnee InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Study Officials

  • Krzysztof Małecki

    PMMHRI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2023

First Posted

March 10, 2023

Study Start

April 1, 2022

Primary Completion

April 1, 2023

Study Completion

December 20, 2023

Last Updated

April 4, 2024

Record last verified: 2022-10

Locations

PL(2)