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Validation of Kujala German

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ClinicalTrials.gov Identifier: NCT01495507
Recruitment Status : Recruiting
First Posted : December 20, 2011
Last Update Posted : July 19, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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. 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)

Condition or disease Intervention/treatment
Validation of Kujala Score German Version in Patients With Patellofemoral Instability and Scheduled MPFL-reconstruction Procedure: MPFL- Reconstruction

Study Design

Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date : November 2011
Estimated Primary Completion Date : January 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Patellofemoral Instability
Patients with diagnosis of patellofemoral instability receiving MPFL-reconstruction as part of the clinical routine
Procedure: MPFL- Reconstruction


Outcome Measures

Primary Outcome Measures :
  1. Kujala Score [ Time Frame: 1 year ]
  2. KOOS (Knee Injury and Osteoarthritis Outcome Score) [ Time Frame: 1 year ]
  3. Marx Activity Scale [ Time Frame: 1 year ]
  4. SF-12 (Short - Form 12) [ Time Frame: 1 year ]
  5. VAS pain [ Time Frame: 1 year ]
  6. Lysholm Score [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with patellofemoral instability & scheduled MPFL-reconstruction
Criteria

Inclusion Criteria:

  • german speaking
  • MPFL-reconstruction planed

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01495507


Contacts
Contact: Michael C Liebensteiner, MD, PhD +43 512 504 80547 michael.liebensteiner@i-med.ac.at

Locations
Austria
Dept. Orthop. Surgery, Medical Univ. Innsbruck Recruiting
Innsbruck, Tyrol, Austria, 6020
Contact: Martin Krismer, Prof.    +43 512 504 22691    martin.krismer@uki.at   
Principal Investigator: Michael C Liebensteiner, MD, PhD         
Sponsors and Collaborators
Medical University Innsbruck
More Information

Responsible Party: Michael Liebensteiner, MD, PhD, Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT01495507     History of Changes
Other Study ID Numbers: Kuj-Germ-1
First Posted: December 20, 2011    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016