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NCT Number: NCT04607538

The Faroese Knee Cohort: Etiology and Long-term Implications of Trochlear Dysplasia and Patellar Dislocations.

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.

1. The patella instability group, in which we intend to investigate the following.

* 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, 2. 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.

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Key information

Age range

15 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Copenhagen University Hospital Hvidovre

Hvidovre, 2650, Denmark

Location status: Recruiting

Location contact

Kristoffer W Barfod, MD, PhD

CONTACT

[email protected]

Kristoffer W Barfod, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

The Faroese Knee Cohort aims to consist of all persons in the Faroe Island between 15-20 years old with patellar instability* (PI) or a knee injury.

Special focus will be on PI, Patella dislocation (PD) and Trochlear Dysplasia (TD), a condition where the femoral trochlea has a dysplastic shape and lacks the lateral support of the patella. The diagnosis will be set by MRI of the knees and is in this study defined as the presence of one of the following: Crossing sign on a true lateral x-ray, lateral trochlear inclination angle < 11 degrees or a trochlear depth < 3 mm.

The hypothesis is that abnormal values in the following measures will be associated with increased risk of patellar dislocation and worse patient reported outcome: Caton-Deschamps index, Lateral Trochlear Inclination, Trochlear Facet Asymmetry, Trochlear Depth, Tuberostias Tibia - Trochlear Groove distance, Patello-trochlear index and Tuberositas Tibia - Posterior Cruciate Ligament distance.

Furthermore, we expect pivoting sports to be a behavioral risk factor.

The primary endpoint is measured by the number of patellar dislocations or near-dislocation the patient experiences (daily, weekly, monthly, yearly).

The secondary endpoint is the patient reported outcome measures.

*Definition: Patellar instability (PI) is the overall term encompassing both 1) recurrent patella dislocations and 2) recurrent episodes of a clear sensation of the kneecap riding on the outer border/aspect of the knee before popping back in track. The episodes must be a severe complaint for the patient. PI usually follows after a first time patellar dislocation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

No intervention is made

Other

No intervention is made. This i an observational study.

Primary outcomes

  1. Severity of patellar dislocations

    Time frame: 1 year

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

Secondary outcomes

  1. Risk factors for patellar dislocation 1

    Time frame: 1 year

    The investigators will investigate if there is an correlation between the amount of patellar dislocations and the following measurements Caton-Deschamps index: Measuring in the ratio from 0-2. (normal 0.6-1.3, patella alta: > 1.3, Patella Baja: <0,6)

  2. Risk factors for patellar dislocation 2

    Time frame: 1 year

    The investigators will investigate if there is an correlation between the amount of patellar dislocations and the following measurements:

    Lateral Trochlear Inclination: Measured in degrees, the range from 0-20 degrees. (< 11 degrees indicates trochlear dysplasia)

  3. Risk factors for patellar dislocation 3

    Time frame: 1 year

    The investigators will investigate if there is an correlation between the amount of patellar dislocations and the following measurements:

    Trochlear Facet Asymmetry: Measured in the ratio from 0-1. ( < 0.4 indicates trochlear dysplasia)

  4. Risk factors for patellar dislocation 4

    Time frame: 1 year

    The investigators will investigate if there is an correlation between the amount of patellar dislocations and the following measurements:

    Trochlear Depth: Measured in centimeters in the range from 0-3 cm. (< 3 cm is abnormal)

  5. Risk factors for patellar dislocation 5

    Time frame: 1 year

    The investigators will investigate if there is an correlation between the amount of patellar dislocations and the following measurements:

    Tuberositas Tibia - Trochlear Groove distance': Measured in mm, in the range from 0-25 mm (< 15 mm is normal, 15-20 is borderline, > 20 mm is abnormal)

  6. Risk factors for patellar dislocation 6

    Time frame: 1 year

    The investigators will investigate if there is an correlation between the amount of patellar dislocations and the following measurements:

    Patello-trochlear index: Is measured in a ratio in percentages. Measurements from 0-100%. (Normal range: 0.18-0.80, patella alta < 0.18, patella baja >0.80)

  7. Patient reported activity

    Time frame: 1 year

    The patient reported outcome measured by the following measurements:

    MARX score (Activity score),

  8. Patient reported luxation score

    Time frame: 1 year

    The patient reported outcome measured by the following measurements

    • Banff Patella Instability Instrument (Luxation score)
  9. Patient reported patellofemoral pain

    Time frame: 1 year

    The patient reported outcome measured by the following measurements

    • The Kujala score (Patellofemoral pain score)

Study contacts

Contact information is provided by the study sponsor or research team.

Kristoffer Barfod, M.D. Ph.D.

CONTACT

[email protected]

+ 45 61300288

Niclas Eysturoy, MD

CONTACT

[email protected]

+298 252629

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

The Faroese Knee Cohort: An Investigation of Etiology and Long-term Implications of Trochlear Dysplasia and Patellar Dislocations

Acronym: FKC

Important dates

Study start
2022
Primary completion
2024
Study completion
2051
First posted
Oct 29, 2020
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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