An observational study in Patellar Dislocation, ACL Injury and Meniscus Lesion, sponsored by Hvidovre University Hospital. Recruiting at 1 site in Denmark. Open to participants aged 15 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-17.
Sponsored by Hvidovre University Hospital · Observational
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.
The patella instability group, in which we intend to investigate the following.
Knee injury group (ACL-ruptur or meniscus injury)
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.
41 studies on the registry are indexed under Patellar Dislocation; 9 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 15 observational studies indexed under Patellar Dislocation.
Browse Patellar Dislocation studies →Hvidovre University Hospital is the lead sponsor of 299 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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.
Severity of patellar dislocations
The severity of PD defined by number of PD or near-dislocations the patient experience (daily, weekly, monthly, yearly).
Time frame: 1 year
Risk factors for patellar dislocation 1
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
Risk factors for patellar dislocation 2
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
Risk factors for patellar dislocation 3
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
Risk factors for patellar dislocation 4
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
Risk factors for patellar dislocation 5
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
Risk factors for patellar dislocation 6
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
Patient reported activity
The patient reported outcome measured by the following measurements: MARX score (Activity score),
Time frame: 1 year
Patient reported luxation score
The patient reported outcome measured by the following measurements - Banff Patella Instability Instrument (Luxation score)
Time frame: 1 year
Patient reported patellofemoral pain
The patient reported outcome measured by the following measurements * The Kujala score (Patellofemoral pain score)
Time frame: 1 year
Plan to share: No
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