Validation of Kujala Score German Version in Patients With Patellofemoral Instability and Scheduled MPFL-reconstruction Clinical Trial
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
| NCT number | NCT01495507 |
| Other study ID # | Kuj-Germ-1 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | December 19, 2011 |
| Last updated | July 16, 2016 |
| Start date | November 2011 |
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)
| Status | Recruiting |
| Enrollment | 45 |
| Est. completion date | |
| Est. primary completion date | January 2017 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 10 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - german speaking - MPFL-reconstruction planed Exclusion Criteria: |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Austria | Dept. Orthop. Surgery, Medical Univ. Innsbruck | Innsbruck | Tyrol |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University Innsbruck |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Kujala Score | 1 year | No | |
| Primary | KOOS (Knee Injury and Osteoarthritis Outcome Score) | 1 year | No | |
| Primary | Marx Activity Scale | 1 year | No | |
| Primary | SF-12 (Short - Form 12) | 1 year | No | |
| Primary | VAS pain | 1 year | No | |
| Primary | Lysholm Score | 1 year | No |