Patella SubluxationKujala-DKNCT06257862
Translation, Cross-cultural Validity and Reliability of a Danish Version of the Anterior Knee Pain Scale
An observational study of Patella Subluxation and Patellofemoral Pain Syndrome, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
The Anterior Knee Pain Scale (Kujala) is a questionnaire designed to assess adults with patellofemoral disorders and is widely used in both anterior knee pain and patellar dislocation patients.The questionnaire is a patient-reported outcome measure (PROM), that was developed in 1993 and has been translated and… Read more about this study
- Who is it for?
- Ages 14 to 40 years
- Conditions the study is for
- Patella Subluxation, Patellofemoral Pain Syndrome
- How many people
- 130 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2024to 31 Dec 2027
- 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
- No healthy volunteers
- Child, Adult
Study population: MPFL-reconstructed patients.
Who may be able to join
- Danish speaking
- MPFL-reconstructed
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Division of Sports Trauma, Palle Juul-Jensens Boulevard 99
Aarhus N, 8200
About this study
Official title: Translation, Cross-cultural Validity and Reliability of a Danish Version of the Anterior Knee Pain Scale (Kujala-DK)
The Anterior Knee Pain Scale (Kujala) is a questionnaire designed to assess adults with patellofemoral disorders and is widely used in both anterior knee pain and patellar dislocation patients.The questionnaire is a patient-reported outcome measure (PROM), that was developed in 1993 and has been translated and validated into most major languages (e.g. French, Italian, Chinese, German, and Spanish) and has gained wide international acceptance. In a recent systematic review, the Kujala was among the eight most commonly used PROMS for patients with patellofemoral pain. In addition, the Kujala was used in almost 80% of studies of patellofemoral instability/dislocation.
The Kujala has been widely used in Denmark during the last 15 years, but surprisingly it has not been translated and validated in Danish according to international guidelines. The translation of the Kujala into Danish will stimulate to more valid and precise results of the Kujala questionnaire in both patients with anterior knee pain and patients with patellar dislocation
The aim of this study is to cross-cultural translate and adapt the Kujala into a Danish Kujala-DK. Secondarily to determine validity and reliability of the Kujala-DK in two consecutive Danish populations of patients with either anterior knee pain or patellar dislocation.
- Conditions
- Patella Subluxation, Patellofemoral Pain Syndrome
- Keywords
- MPFL, KUJALA, PAIN, Questionnaire, TRANSLATION
- Medical subject headings
- Patellofemoral Pain Syndrome, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Kujala (Anterior Knee Pain Scale)
Patient reported outcome score. (0-100 (0 = Worst, 100 = Best)
Measured: Baseline, after 6-8 days
Victorian Institute of Sports Assessment - Patella questionnaire (VISA-P)
Patient reported outcome score. (0-100 (0 = Worst, 100 = Best)
Measured: Baseline
International knee documentation committee (IKDC)
Patient reported outcome score. (0-100 (0 = Worst, 100 = Best)
Measured: Baseline
Banff patella instability instrument (BPII 2.0)
Patient reported outcome score. (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 completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patella SubluxationStudies 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
- 130 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
- NCT06257862
- Sponsor's protocol ID
- Questionnaire KUJALA-DK
- Acronym
- Kujala-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
- Translation, Cross-cultural Validity and Reliability of a Danish Version of the Anterior Knee Pain Scale (Kujala-DK)
- ClinicalTrials.gov ID
- NCT06257862
- Acronym / sponsor ID
- Kujala-DK / Questionnaire KUJALA-DK
- Conditions
- Patella Subluxation, Patellofemoral Pain Syndrome
- Keywords
- MPFL, KUJALA, PAIN, Questionnaire, TRANSLATION
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (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 Anterior Knee Pain Scale (Kujala) is a questionnaire designed to assess adults with patellofemoral disorders and is widely used in both anterior knee pain and patellar dislocation patients.The questionnaire is a patient-reported outcome measure (PROM), that was developed in 1993 and has been translated and validated into most major languages (e.g. French, Italian, Chinese, German, and Spanish) and has gained wide international acceptance. In a recent systematic review, the Kujala was among the eight most commonly used PROMS for patients with patellofemoral pain. In addition, the Kujala was used in almost 80% of studies of patellofemoral instability/dislocation.
The Kujala has been widely used in Denmark during the last 15 years, but surprisingly it has not been translated and validated in Danish according to international guidelines. The translation of the Kujala into Danish will stimulate to more valid and precise results of the Kujala questionnaire in both patients with anterior knee pain and patients with patellar dislocation
The aim of this study is to cross-cultural translate and adapt the Kujala into a Danish Kujala-DK. Secondarily to determine validity and reliability of the Kujala-DK in two consecutive Danish populations of patients with either anterior knee pain or patellar dislocation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- MPFL-reconstructed patients.
Key inclusion criteria (2 listed)
- Danish speaking
- MPFL-reconstructed
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Kujala (Anterior Knee Pain Scale)
Time frame: Baseline, after 6-8 days
Patient reported outcome score. (0-100 (0 = Worst, 100 = Best)
Victorian Institute of Sports Assessment - Patella questionnaire (VISA-P)
Time frame: Baseline
Patient reported outcome score. (0-100 (0 = Worst, 100 = Best)
International knee documentation committee (IKDC)
Time frame: Baseline
Patient reported outcome score. (0-100 (0 = Worst, 100 = Best)
Banff patella instability instrument (BPII 2.0)
Time frame: Baseline
Patient reported outcome score. (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.
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.
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 Patella Subluxation and Patellofemoral Pain Syndrome, run by Aarhus 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 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 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?
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?
Kujala (Anterior Knee Pain Scale) (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; AzTrials last refreshed its copy on 7 Nov 2026.