Validation of Kujala German

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Medical University Innsbruck
Sponsor:
Information provided by (Responsible Party):
Michael Liebensteiner, Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT01495507
First received: December 19, 2011
Last updated: April 7, 2015
Last verified: April 2015
  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 Medical University Innsbruck:

Primary Outcome Measures:
  • Kujala Score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • KOOS (Knee Injury and Osteoarthritis Outcome Score) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Marx Activity Scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • SF-12 (Short - Form 12) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • VAS pain [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Lysholm Score [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   10 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Michael Liebensteiner, MD, PhD, Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT01495507     History of Changes
Other Study ID Numbers: Kuj-Germ-1
Study First Received: December 19, 2011
Last Updated: April 7, 2015
Health Authority: Austria: Ethikkommission

ClinicalTrials.gov processed this record on August 30, 2015