NCT04607538

Brief Summary

The investigators intend to establish a national cohort including all persons in the ages from 15-20 years old with patellar instability (PI) or a prior knee injury (ACL-ruptur or meniscus damage) . The cohort will be nicknamed "The Faroese Knee Cohort". The overall aim is to investigate two groups.

  • Prevalence of patellar dislocation and trochlear dysplasia in the Faroe Islands.
  • Risk factors for patellar dislocations-
  • Heredity of trochlear dysplasia.
  • If there is a specific gene responsible for the development of trochlear dysplasia.
  • The development of retropatellar artrhosis, its onset and its impact on quality of life and function,
  • Knee injury group (ACL-ruptur or meniscus injury)
  • The prevalence of ACL-rupture and/or meniscus injury in this specific group in the Faroe Islands.
  • The impact on quality of life and function.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
311mo left

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress14%
Mar 2022Dec 2051

First Submitted

Initial submission to the registry

June 18, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 29, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
27.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2051

Expected
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

2.7 years

First QC Date

June 18, 2020

Last Update Submit

February 15, 2023

Conditions

Patellar DislocationACL InjuryMeniscus LesionTrochlear Dysplasia

Keywords

Patellar instabilityPatellar dislocationACL-ruptureMeniscus lesionMeniscus injury

Outcome Measures

Primary Outcomes (1)

  • Severity of patellar dislocations

    The severity of PD defined by number of PD or near-dislocations the patient experience (daily, weekly, monthly, yearly).

    1 year

Secondary Outcomes (9)

  • Risk factors for patellar dislocation 1

    1 year

  • Risk factors for patellar dislocation 2

    1 year

  • Risk factors for patellar dislocation 3

    1 year

  • Risk factors for patellar dislocation 4

    1 year

  • Risk factors for patellar dislocation 5

    1 year

  • +4 more secondary outcomes

Study Arms (3)

Patellar dislocation, but no trochlear dysplasia

This group consist of patients in age from 15-20 years old in the Faroe Islands, who experience patellar dislocation, but do not have femoral trochlear dysplasia measured on MRI or X-ray

Other: No intervention is made

Patiens with patellar dislocation and trochlear dysplasia

This group consists of patients in the age from 15-20 years old in the Faroe Islands, who have experience one or more patellar dislocations and have femoral trochlear dysplasia measured on MRI or X-ray

Other: No intervention is made

Patients with other knee injury

This group consists of patients in the age from 15-20 years old in the Faroe Islands, who have had an ACL-rupture or an meniscus injury.

Other: No intervention is made

Interventions

No intervention is madeOTHER

No intervention is made. This i an observational study.

Patellar dislocation, but no trochlear dysplasiaPatiens with patellar dislocation and trochlear dysplasiaPatients with other knee injury

Eligibility Criteria

Age15 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All patients must either live or be born in the Faroe Islands, as this is a national cohort study. They will be invited to join the study if the live up to the inclusion criteria.

You may qualify if:

  • Age between 15-20 years at the start of patient enrolment.
  • The feeling of patellar instability, or patellar dislocation/near-dislocation.
  • The person has to be from the Faroe Islands.
  • All persons under the age of 18 must get written consent by their parents

You may not qualify if:

  • Terminal illness
  • Mental disabilities and illness, meaning that the patient cannot independently answer the PROM´s and cooperate to the clinical investigation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital Hvidovre

Hvidovre, 2650, Denmark

RECRUITING

MeSH Terms

Conditions

Patellar DislocationAnterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesKnee InjuriesLeg Injuries

Central Study Contacts

Niclas Eysturoy, MD

CONTACT

+298 252629nicey@ls.fo

Kristoffer Barfod, M.D. Ph.D.

CONTACT

+ 45 61300288kbarfod@dadlnet.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. Ph.D. Associate Professor

Study Record Dates

First Submitted

June 18, 2020

First Posted

October 29, 2020

Study Start

March 1, 2022

Primary Completion

November 1, 2024

Study Completion (Estimated)

December 1, 2051

Last Updated

February 17, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)