Copenhagen University Hospital Hvidovre
Hvidovre, 2650, Denmark
Location status: Recruiting
Location contact
Kristoffer W Barfod, MD, PhD
CONTACT
Kristoffer W Barfod, MD, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT04607538
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.
Interested in participating?
Request Info15 year–20 year
All sexes
Observational
Hvidovre, 2650, Denmark
Location status: Recruiting
Kristoffer W Barfod, MD, PhD
CONTACT
Kristoffer W Barfod, MD, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No intervention is made. This i an observational study.
Time frame: 1 year
The severity of PD defined by number of PD or near-dislocations the patient experience (daily, weekly, monthly, yearly).
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)
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)
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)
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)
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)
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)
Time frame: 1 year
The patient reported outcome measured by the following measurements:
MARX score (Activity score),
Time frame: 1 year
The patient reported outcome measured by the following measurements
Time frame: 1 year
The patient reported outcome measured by the following measurements
Contact information is provided by the study sponsor or research team.
Kristoffer Barfod, M.D. Ph.D.
CONTACT
Niclas Eysturoy, MD
CONTACT
Hvidovre University Hospital
Other
The Faroese Knee Cohort: An Investigation of Etiology and Long-term Implications of Trochlear Dysplasia and Patellar Dislocations
Acronym: FKC
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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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