Patellar DislocationFKCNCT04607538
The Faroese Knee Cohort: Etiology and Long-term Implications of Trochlear Dysplasia and Patellar Dislocations.
An observational study of Patellar Dislocation and ACL Injury, run by Hvidovre University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Patellar Dislocation, ACL Injury, Meniscus Lesion
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2022to 1 Dec 2051
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Terminal illness
- Mental disabilities and illness, meaning that the patient cannot independently answer the PROM´s and cooperate to the clinical investigation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital Hvidovre
Hvidovre, 2650
Kristoffer W Barfod, MD, PhD, kbarfod@dadlnet.dk
Kristoffer W Barfod, MD, PhD
About this study
Official 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.
Read more
- 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,
- 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.
Read the 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.
- Conditions
- Patellar Dislocation, ACL Injury, Meniscus Lesion, Trochlear Dysplasia
- Being tested
- No intervention is made
- Keywords
- Patellar instability, Patellar dislocation, ACL-rupture, Meniscus lesion, Meniscus injury
- Medical subject headings
- Patellar Dislocation, Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention is madeOther
No intervention is made. This i an observational study.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: No intervention is made | |
| 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 Receives: Other: No intervention is made | |
| 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. Receives: Other: No intervention is made |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of patellar dislocations
The severity of PD defined by number of PD or near-dislocations the patient experience (daily, weekly, monthly, yearly).
Measured: 1 year
Secondary outcomes (9)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 1 year
Patient reported activity
The patient reported outcome measured by the following measurements:
MARX score (Activity score),
Measured: 1 year
Patient reported luxation score
The patient reported outcome measured by the following measurements
- Banff Patella Instability Instrument (Luxation score)
Measured: 1 year
Patient reported patellofemoral pain
The patient reported outcome measured by the following measurements
- The Kujala score (Patellofemoral pain score)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start1 Mar 2022
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Dec 2051 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellar DislocationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristoffer Barfod, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607538
- Sponsor's protocol ID
- FaroeseKneeCohort
- Acronym
- FKC
- Status last verified
- Feb 2023
- First submitted
- 18 Jun 2020
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Faroese Knee Cohort: An Investigation of Etiology and Long-term Implications of Trochlear Dysplasia and Patellar Dislocations
- ClinicalTrials.gov ID
- NCT04607538
- Acronym / sponsor ID
- FKC / FaroeseKneeCohort
- Conditions
- Patellar Dislocation, ACL Injury, Meniscus Lesion, Trochlear Dysplasia
- Keywords
- Patellar instability, Patellar dislocation, ACL-rupture, Meniscus lesion, Meniscus injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Dec 2051 (estimated)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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,
- 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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patellar dislocation, but no trochlear dysplasia | – | Other: No intervention is madeThis 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 |
| Patiens with patellar dislocation and trochlear dysplasia | – | Other: No intervention is madeThis 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 |
| Patients with other knee injury | – | Other: No intervention is madeThis 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. |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Terminal illness
- Mental disabilities and illness, meaning that the patient cannot independently answer the PROM´s and cooperate to the clinical investigation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention is madeNo intervention is made. This i an observational study. | Other | Patellar dislocation, but no trochlear dysplasia, Patiens with patellar dislocation and trochlear dysplasia, Patients with other knee injury |
Primary outcome
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).
9 secondary outcomes
Risk factors for patellar dislocation 1
Time frame: 1 year
Risk factors for patellar dislocation 2
Time frame: 1 year
Risk factors for patellar dislocation 3
Time frame: 1 year
Risk factors for patellar dislocation 4
Time frame: 1 year
Risk factors for patellar dislocation 5
Time frame: 1 year
Risk factors for patellar dislocation 6
Time frame: 1 year
Patient reported activity
Time frame: 1 year
Patient reported luxation score
Time frame: 1 year
Patient reported patellofemoral pain
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Individual participant dataSharing planned: No
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Effects of Preoperative Rehabilitation on Tendon Healing, Bone Mineral Density, and Cartilage After ACLR and Patellar Dislocation
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JUPITER 4.0 - Risk Factors for Failure of Isolated Medial Patellofemoral Ligament Reconstruction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patellar Dislocation and ACL Injury, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Niclas Eysturoy, MD (+298 252629, nicey@ls.fo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of patellar dislocations (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.