We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Validation of Kujala German

This study is currently recruiting participants.
Verified July 2016 by Michael Liebensteiner, Medical University Innsbruck
Sponsor:
ClinicalTrials.gov Identifier:
NCT01495507
First Posted: December 20, 2011
Last Update Posted: July 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Liebensteiner, Medical University Innsbruck
  Purpose

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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Michael Liebensteiner, Medical University Innsbruck:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 45
Study Start Date: November 2011
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patellofemoral Instability
Patients with diagnosis of patellofemoral instability receiving MPFL-reconstruction as part of the clinical routine
Procedure: MPFL- Reconstruction

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: December 19, 2011
First Posted: December 20, 2011
Last Update Posted: July 19, 2016
Last Verified: July 2016