Clinical Significance and Coexistence of Polymorphisms of... | NCT05763108

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

NCT05763108

Sponsor

Polish Mother Memorial Hospital Research Institute

Status

Completed

Last Update Posted

Apr 4, 2024Actual

Enrollment

250Actual

Phase

Not provided

Conditions

Ligament; Laxity
Recurrent Patellar Dislocation

Interventions

genetic test
Beighton joint laxity test

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2022Actual

Primary Completion Date

Apr 1, 2023Actual

Completion Date

Dec 20, 2023Actual

First Submitted Date

Feb 28, 2023

First Submission Date that Met QC Criteria

Feb 28, 2023

First Posted Date

Mar 10, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2024

Last Update Posted Date

Apr 4, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
genetic test	Diagnostic Test	COL1A1 or COL5A1 genetic test	Patients without joint hipermobility Recurrent patellar dislocation group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Krzysztof Małecki	PMMHRI	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Krzysztof Małecki		Lodz	Lodzkie Voivodeship	93-160	Poland
Krzysztof Małecki

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007593	Joint Instability
D031222	Patellar Dislocation

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D004204	Joint Dislocations
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005820	Genetic Testing

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided