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

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ClinicalTrials.gov Identifier: NCT04607538
Recruitment Status : Not yet recruiting
First Posted : October 29, 2020
Last Update Posted : October 19, 2021
Sponsor:
Information provided by (Responsible Party):
Kristoffer Barfod, Hvidovre University Hospital

Study Description
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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.

  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.

Condition or disease Intervention/treatment
Patellar Dislocation ACL Injury Meniscus Lesion Trochlear Dysplasia Other: No intervention is made

Detailed Description:

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Faroese Knee Cohort: An Investigation of Etiology and Long-term Implications of Trochlear Dysplasia and Patellar Dislocations
Estimated Study Start Date : December 1, 2021
Estimated Primary Completion Date : November 1, 2024
Estimated Study Completion Date : December 1, 2051

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dislocations

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
No intervention is made. This i an observational study.
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
No intervention is made. This i an observational study.
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
No intervention is made. This i an observational study.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04607538


Contacts
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Contact: Niclas Eysturoy, MD +298 252629 nicey@ls.fo
Contact: Kristoffer Barfod, M.D. Ph.D. + 45 61300288 kbarfod@dadlnet.dk

Locations
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Denmark
Copenhagen University Hospital Hvidovre
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
More Information
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Responsible Party: Kristoffer Barfod, MD. Ph.D. Associate Professor, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT04607538    
Other Study ID Numbers: FaroeseKneeCohort
First Posted: October 29, 2020    Key Record Dates
Last Update Posted: October 19, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kristoffer Barfod, Hvidovre University Hospital:
Patellar instability
Patellar dislocation
ACL-rupture
Meniscus lesion
Meniscus injury
Additional relevant MeSH terms:
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Joint Dislocations
Patellar Dislocation
Anterior Cruciate Ligament Injuries
Joint Diseases
 Musculoskeletal Diseases
Wounds and Injuries
Knee Injuries
Leg Injuries