Ligament; LaxityNCT05763108
Clinical Significance and Coexistence of Polymorphisms of Individual Collagen-coding Genes
An observational study of Ligament; Laxity and Recurrent Patellar Dislocation, run by Polish Mother Memorial Hospital Research Institute at 2 sites in Poland.
Trial 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 more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Ligament; Laxity, Recurrent Patellar Dislocation
- What is being tested?
- genetic test and Beighton joint laxity test
- How many people
- 250 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Apr 2022to 20 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Patients between 7 and 17 years old with recurrent dislocation of the patella without genetic diseases.
Who may be able to join
- First-time diagnosed or recurrent patellar dislocation patient from 7 to 17 age years old.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Krzysztof Małecki
Lodz, Lodzkie Voivodeship, 93-160
Krzysztof Małecki
Lodz, Lodzkie Voivodeship, 93-338
About this study
Official 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.
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.
- Conditions
- Ligament; Laxity, Recurrent Patellar Dislocation
- Being tested
- genetic test, Beighton joint laxity test
- Medical subject headings
- Joint Instability, Patellar Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genetic testDiagnostic test
COL1A1 or COL5A1 genetic test
Beighton joint laxity testOther
Based on Beighton scale.
| Study group | Role | What they receive |
|---|---|---|
| Recurrent patellar dislocation group | 50 patients with recurrent patellar dislocation and without any genetic disorders. Receives: Diagnostic Test: genetic test; Other: Beighton joint laxity test | |
| Patients without joint hipermobility | 200 patients without recurrent patellar dislocation and genetic disorders. Receives: Diagnostic Test: genetic test; Other: Beighton joint laxity test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients with recurrent patellar dislocation
Patients with recurrent patellar dislocation
Measured: 2022-2023
Control group without obvious joint hipermobility
Control group without obvious joint hipermobility
Measured: 2022-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start1 Apr 2022
- Primary completion1 Apr 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ligament; LaxityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polish Mother Memorial Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Krzysztof Małecki, Principal investigator, PMMHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763108
- Sponsor's protocol ID
- PMMHRI-2021.2/1/7-GW
- Status last verified
- Oct 2022
- First submitted
- 28 Feb 2023
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT05763108
- Acronym / sponsor ID
- PMMHRI-2021.2/1/7-GW
- Conditions
- Ligament; Laxity, Recurrent Patellar Dislocation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Polish Mother Memorial Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recurrent patellar dislocation group | – | Diagnostic Test: genetic test, Other: Beighton joint laxity test50 patients with recurrent patellar dislocation and without any genetic disorders. |
| Patients without joint hipermobility | – | Diagnostic Test: genetic test, Other: Beighton joint laxity test200 patients without recurrent patellar dislocation and genetic disorders. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients between 7 and 17 years old with recurrent dislocation of the patella without genetic diseases.
Key inclusion criteria (1 listed)
- First-time diagnosed or recurrent patellar dislocation patient from 7 to 17 age years old.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genetic testCOL1A1 or COL5A1 genetic test | Diagnostic test | Patients without joint hipermobility, Recurrent patellar dislocation group |
| Beighton joint laxity testBased on Beighton scale. | Other | Patients without joint hipermobility, Recurrent patellar dislocation group |
Primary outcome
Patients with recurrent patellar dislocation
Time frame: 2022-2023
Patients with recurrent patellar dislocation
Control group without obvious joint hipermobility
Time frame: 2022-2023
Control group without obvious joint hipermobility
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krzysztof Małecki principal investigator
PMMHRI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ligament; Laxity and Recurrent Patellar Dislocation, run by Polish Mother Memorial Hospital Research Institute at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients with recurrent patellar dislocation (time frame: 2022-2023). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.