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CompletedNCT05763108Updated Apr 4, 2024

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

An observational study in Ligament; Laxity and Recurrent Patellar Dislocation, sponsored by Polish Mother Memorial Hospital Research Institute. Completed at 2 sites in Poland. Open to participants aged 7 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-04.

Sponsored by Polish Mother Memorial Hospital Research Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
7 Years to 17 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ligament; Laxity
  • Recurrent Patellar Dislocation
03

In context

Joint Instability

115 studies on the registry are indexed under Joint Instability; 21 are open to participants now.

This study's enrollment of 250 is above the median of 60 across 54 observational studies indexed under Joint Instability.

Browse Joint Instability studies →

Lead sponsor

Polish Mother Memorial Hospital Research Institute is the lead sponsor of 19 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 17 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Recurrent patellar dislocation group

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

    Diagnostic Test: genetic test · Other: Beighton joint laxity test

  • Patients without joint hipermobility

    200 patients without recurrent patellar dislocation and genetic disorders.

    Diagnostic Test: genetic test · Other: Beighton joint laxity test

Interventions

  • Diagnostic testgenetic test

    COL1A1 or COL5A1 genetic test

  • OtherBeighton joint laxity test

    Based on Beighton scale.

06

What researchers measure

Primary outcomes

  1. Patients with recurrent patellar dislocation

    Patients with recurrent patellar dislocation

    Time frame: 2022-2023

  2. Control group without obvious joint hipermobility

    Control group without obvious joint hipermobility

    Time frame: 2022-2023

07

Study locations

2 sites
  • Krzysztof Małecki
    Lodz, Lodzkie Voivodeship 93-338, Poland
  • Krzysztof Małecki
    Łódź, Lodzkie Voivodeship 93-160, Poland
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2022 to primary completion in Apr 2023, 12 months.

Of 22 observational studies under Joint Instability, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 35. This study's 12 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 28, 2023
First posted
Mar 10, 2023
StartActual
Apr 1, 2022
Primary completionActual
Apr 1, 2023
CompletionActual
Dec 20, 2023
Last update
Apr 4, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05763108
Lead sponsor
Polish Mother Memorial Hospital Research Institute
Responsible party
Sponsor
First posted
Mar 10, 2023
Start date
Apr 1, 2022
Primary completion
Apr 1, 2023
Completion
Dec 20, 2023
Last update
Apr 4, 2024

Study contacts

Krzysztof Małecki
principal investigator · PMMHRI

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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