ACL Injury Clinical Trial
— FKCOfficial title:
The Faroese Knee Cohort: An Investigation of 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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 1, 2051 |
Est. primary completion date | November 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 15 Years to 20 Years |
Eligibility | 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 PROMĀ“s and cooperate to the clinical investigation. |
Country | Name | City | State |
---|---|---|---|
Denmark | Copenhagen University Hospital Hvidovre | Hvidovre |
Lead Sponsor | Collaborator |
---|---|
Hvidovre University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Severity of patellar dislocations | The severity of PD defined by number of PD or near-dislocations the patient experience (daily, weekly, monthly, yearly). | 1 year | |
Secondary | 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) | 1 year | |
Secondary | 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) |
1 year | |
Secondary | 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) |
1 year | |
Secondary | 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) |
1 year | |
Secondary | 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) |
1 year | |
Secondary | 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) |
1 year | |
Secondary | Patient reported activity | The patient reported outcome measured by the following measurements:
MARX score (Activity score), |
1 year | |
Secondary | Patient reported luxation score | The patient reported outcome measured by the following measurements
- Banff Patella Instability Instrument (Luxation score) |
1 year | |
Secondary | Patient reported patellofemoral pain | The patient reported outcome measured by the following measurements
The Kujala score (Patellofemoral pain score) |
1 year |
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