The Faroese Knee Cohort: Etiology and Long-term Implications of Trochlear Dysplasia and Patellar Dislocations.
NCT ID: NCT04607538
Last Updated: 2023-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2022-03-01
2051-12-01
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
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
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.
No intervention is made
No intervention is made. This i an observational study.
Interventions
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No intervention is made
No intervention is made. This i an observational study.
Eligibility Criteria
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Inclusion Criteria
* 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
* Mental disabilities and illness, meaning that the patient cannot independently answer the PROM´s and cooperate to the clinical investigation.
15 Years
20 Years
ALL
Yes
Sponsors
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Hvidovre University Hospital
OTHER
Responsible Party
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Kristoffer Barfod
MD. Ph.D. Associate Professor
Locations
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Copenhagen University Hospital Hvidovre
Hvidovre, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FaroeseKneeCohort
Identifier Type: -
Identifier Source: org_study_id
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