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Validation of Kujala German

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Medical University Innsbruck.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT01495507
First received: December 19, 2011
Last updated: June 25, 2012
Last verified: June 2012
  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
  • KOOS (Knee Injury and Osteoarthritis Outcome Score)
  • Marx Activity Scale
  • SF-12 (Short - Form 12)
  • VAS pain
  • Lysholm Score

Study Start Date: November 2011
Groups/Cohorts Assigned Interventions
Patellofemoral Instability Procedure: MPFL- Reconstruction

  Eligibility

Ages Eligible for Study:   10 Years to 70 Years
Genders Eligible for Study:   Both
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

ClinicalTrials.gov Identifier: NCT01495507     History of Changes
Other Study ID Numbers: Kuj-Germ-1
Study First Received: December 19, 2011
Last Updated: June 25, 2012
Health Authority: Austria: Ethikkommission

ClinicalTrials.gov processed this record on November 24, 2014