Validation of Kujala Score German Version in Patients With Patellofemoral Instability and Scheduled MPFL-reconstructionNCT01495507
Validation of Kujala German
An observational study of Validation of Kujala Score German Version in Patients With Patellofemoral Instability and Scheduled MPFL-reconstruction, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
The field of patellofemoral disorders and accordant therapeutical interventions is a high turnover research field. It is important to verify the clinical outcome with appropriate measuring tools. There is evidence that the Kujala score is a reliable and widely used measuring instrument of patellofemoral disorders. Read more about this study
- Who is it for?
- Ages 10 to 70 years
- Conditions the study is for
- Validation of Kujala Score German Version in Patients With Patellofemoral Instability and Scheduled MPFL-reconstruction
- What is being tested?
- MPFL- Reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2011to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 10 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with patellofemoral instability \& scheduled MPFL-reconstruction
Who may be able to join
- german speaking
- MPFL-reconstruction planed
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Dept. Orthop. Surgery, Medical Univ. Innsbruck
Innsbruck, Tyrol, 6020
Martin Krismer, Prof., +43 512 504 22691, martin.krismer@uki.at
Michael C Liebensteiner, MD, PhD
About this study
Official title: Cross-cultural Adaptation and Validation of the German Version of the Kujala Score in Patients With Patellofemoral Instability - a Prospective Multi-centric Study
The field of patellofemoral disorders and accordant therapeutical interventions is a high turnover research field. It is important to verify the clinical outcome with appropriate measuring tools. There is evidence that the Kujala score is a reliable and widely used measuring instrument of patellofemoral disorders. Indeed, the Kujala score was already used in many studies investigating patellofemoral disorders - also in german speaking patient groups. Unfortunately, we are not aware of a validated german version of the Kujala score. Other relevant knee outcome scores were already successfully translated into german language and validated by previous investigators.
So, it is the aim of our study to cross-culturally adapt and then to validate the Kujala score for use in German-speaking individuals with patellofemoral instability. It is hypothesized that the german version of the Kujala score shows:
- High divergent construct validity as determined by significant differences between patients and controls (hypothesis 1)
- High convergent construct validity as determined by significant correlations with other relevant scoring systems (hypothesis 2)
- High reliability (hypothesis 3)
- High responsiveness (hypothesis 4)
- Being tested
- MPFL- Reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPFL- ReconstructionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patellofemoral Instability | Patients with diagnosis of patellofemoral instability receiving MPFL-reconstruction as part of the clinical routine Receives: Procedure: MPFL- Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kujala Score
Measured: 1 year
KOOS (Knee Injury and Osteoarthritis Outcome Score)
Measured: 1 year
Marx Activity Scale
Measured: 1 year
SF-12 (Short - Form 12)
Measured: 1 year
VAS pain
Measured: 1 year
Lysholm 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 posted20 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Validation of Kujala Score German Version in Patients With Patellofemoral Instability and Scheduled MPFL-reconstructionStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Liebensteiner, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01495507
- Sponsor's protocol ID
- Kuj-Germ-1
- Status last verified
- Jul 2016
- First submitted
- 19 Dec 2011
- Last updated
- 19 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Adaptation and Validation of the German Version of the Kujala Score in Patients With Patellofemoral Instability - a Prospective Multi-centric Study
- ClinicalTrials.gov ID
- NCT01495507
- Acronym / sponsor ID
- Kuj-Germ-1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jan 2017 (estimated)
- First posted
- 20 Dec 2011 (estimated)
- 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 field of patellofemoral disorders and accordant therapeutical interventions is a high turnover research field. It is important to verify the clinical outcome with appropriate measuring tools. There is evidence that the Kujala score is a reliable and widely used measuring instrument of patellofemoral disorders. Indeed, the Kujala score was already used in many studies investigating patellofemoral disorders - also in german speaking patient groups. Unfortunately, we are not aware of a validated german version of the Kujala score. Other relevant knee outcome scores were already successfully translated into german language and validated by previous investigators.
So, it is the aim of our study to cross-culturally adapt and then to validate the Kujala score for use in German-speaking individuals with patellofemoral instability. It is hypothesized that the german version of the Kujala score shows:
- High divergent construct validity as determined by significant differences between patients and controls (hypothesis 1)
- High convergent construct validity as determined by significant correlations with other relevant scoring systems (hypothesis 2)
- High reliability (hypothesis 3)
- High responsiveness (hypothesis 4)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patellofemoral Instability | – | Procedure: MPFL- ReconstructionPatients with diagnosis of patellofemoral instability receiving MPFL-reconstruction as part of the clinical routine |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with patellofemoral instability \& scheduled MPFL-reconstruction
Key inclusion criteria (2 listed)
- german speaking
- MPFL-reconstruction planed
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| MPFL- Reconstruction | Procedure or surgery | Patellofemoral Instability |
Primary outcome
Kujala Score
Time frame: 1 year
KOOS (Knee Injury and Osteoarthritis Outcome Score)
Time frame: 1 year
Marx Activity Scale
Time frame: 1 year
SF-12 (Short - Form 12)
Time frame: 1 year
VAS pain
Time frame: 1 year
Lysholm Score
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
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.
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 Validation of Kujala Score German Version in Patients With Patellofemoral Instability and Scheduled MPFL-reconstruction, run by Medical University Innsbruck at 1 site in Austria.
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 0 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: status not confirmed, as of the sponsor's last update on 19 Jul 2016. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael C Liebensteiner, MD, PhD (+43 512 504 80547, michael.liebensteiner@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kujala Score (time frame: 1 year). The study lists 6 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 19 Jul 2016; AzTrials last refreshed its copy on 30 Oct 2026.