Patella DysplasiaNCT06257849
Validity and Reliability of a Danish Version of the Banff Patella Instability Instrument (BPII 2.0-DK)
An observational study of Patella Dysplasia, run by Aarhus University Hospital at 2 sites in Denmark.
Trial summary
The Banff Patella Instability Instrument (BPII 2.0) is a disease-specific quality of life questionnaire designed to assess adults with patellar dislocations. As the BPII 2.0 already is cross-cultural translate and adapted to Danish the examination of the the psychometric properties of the Danish version is still… Read more about this study
- Who is it for?
- Ages 14 to 40 years
- Conditions the study is for
- Patella Dysplasia
- What is being tested?
- BPII 2.0
- How many people
- 65 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Mar 2024to 31 Dec 2026
- 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 14 to 40 years
- All sexes
- Child, Adult
Study population: Patients with Patella instability
Who may be able to join
- Danish Speaking
- Patella instability problems
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aarhus University Hospital
Aarhus, 8200
Division of Sports Trauma, Palle Juul-Jensens Boulevard 99
Aarhus N, 8200
About this study
The Banff Patella Instability Instrument (BPII 2.0) is a disease-specific quality of life questionnaire designed to assess adults with patellar dislocations.
As the BPII 2.0 already is cross-cultural translate and adapted to Danish the examination of the the psychometric properties of the Danish version is still needed
The aim om this study is to determine validity and reliability of the Danish version BPII 2.0-DK in a Danish populations of patients with patellar dislocation.
- Conditions
- Patella Dysplasia
- Being tested
- BPII 2.0
- Keywords
- BPII 2.0, Patella instability, Knee, Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPII 2.0Other
Also called Banff Patella Instability Instrument 2.0
Banff Patella Instability Instrument 2.0 is a questionnaire developed for measuring outcome in patients with patella instability
What is being measured
The primary outcome is the main question the study is designed to answer.
Banff patella instability instrument (BPII 2.0)
Questionnaire. (0-100 (0 = Worst, 100 = Best))
Measured: Baseline, after 6-8 days
Anterior knee pain scale (Kujala)
Questionnaire. (0-100 (0 = Worst, 100 = Best))
Measured: Baseline
Victorian Institute of Sports Assessment - Patella questionnaire (VISA-P)
Questionnaire. (0-100 (0 = Worst, 100 = Best))
Measured: Baseline
International knee documentation committee (IKDC)
Questionnaire. (0-100 (0 = Worst, 100 = Best))
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Mar 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patella DysplasiaStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- 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
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Lind, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257849
- Sponsor's protocol ID
- Questionnaire BPII 2.0-DK
- Status last verified
- Sep 2025
- First submitted
- 6 Feb 2024
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of a Danish Version of the Banff Patella Instability Instrument (BPII 2.0-DK)
- ClinicalTrials.gov ID
- NCT06257849
- Acronym / sponsor ID
- Questionnaire BPII 2.0-DK
- Conditions
- Patella Dysplasia
- Keywords
- BPII 2.0, Patella instability, Knee, Questionnaire
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Feb 2024 (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 Banff Patella Instability Instrument (BPII 2.0) is a disease-specific quality of life questionnaire designed to assess adults with patellar dislocations.
As the BPII 2.0 already is cross-cultural translate and adapted to Danish the examination of the the psychometric properties of the Danish version is still needed
The aim om this study is to determine validity and reliability of the Danish version BPII 2.0-DK in a Danish populations of patients with patellar dislocation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients with Patella instability
Key inclusion criteria (2 listed)
- Danish Speaking
- Patella instability problems
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| BPII 2.0Also: Banff Patella Instability Instrument 2.0Banff Patella Instability Instrument 2.0 is a questionnaire developed for measuring outcome in patients with patella instability | Other | – |
Primary outcome
Banff patella instability instrument (BPII 2.0)
Time frame: Baseline, after 6-8 days
Questionnaire. (0-100 (0 = Worst, 100 = Best))
Anterior knee pain scale (Kujala)
Time frame: Baseline
Questionnaire. (0-100 (0 = Worst, 100 = Best))
Victorian Institute of Sports Assessment - Patella questionnaire (VISA-P)
Time frame: Baseline
Questionnaire. (0-100 (0 = Worst, 100 = Best))
International knee documentation committee (IKDC)
Time frame: Baseline
Questionnaire. (0-100 (0 = Worst, 100 = Best))
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 1 Oct 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patella Dysplasia, run by Aarhus University Hospital at 2 sites 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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Banff patella instability instrument (BPII 2.0) (time frame: Baseline, after 6-8 days). The study lists 4 primary outcomes in all. 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 1 Oct 2025.