- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01495507
Validation of Kujala German
Cross-cultural Adaptation and Validation of the German Version of the Kujala Score in Patients With Patellofemoral Instability - a Prospective Multi-centric Study
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)
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Tyrol
-
Innsbruck, Tyrol, Austria, 6020
- Recruiting
- Dept. Orthop. Surgery, Medical Univ. Innsbruck
-
Principal Investigator:
- Michael C Liebensteiner, MD, PhD
-
Contact:
- Martin Krismer, Prof.
- Phone Number: +43 512 504 22691
- Email: martin.krismer@uki.at
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- german speaking
- MPFL-reconstruction planed
Exclusion Criteria:
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patellofemoral Instability
Patients with diagnosis of patellofemoral instability receiving MPFL-reconstruction as part of the clinical routine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Kujala Score
Time Frame: 1 year
|
1 year
|
|
KOOS (Knee Injury and Osteoarthritis Outcome Score)
Time Frame: 1 year
|
1 year
|
|
Marx Activity Scale
Time Frame: 1 year
|
1 year
|
|
SF-12 (Short - Form 12)
Time Frame: 1 year
|
1 year
|
|
VAS pain
Time Frame: 1 year
|
1 year
|
|
Lysholm Score
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Kuj-Germ-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on MPFL- Reconstruction
-
Assiut UniversityNot yet recruiting
-
Aarhus University HospitalActive, not recruitingMedial Patellofemoral Dislocation | Medial Patellofemoral Ligament ReconstructionDenmark
-
Polish Mother Memorial Hospital Research InstituteCompletedThe Comprehensive Assessment in Children After Surgical Treatment of Patellar Recurrent Dislocation.Recurrent Patellar Dislocation | Patellar InstabilityPoland
-
Yu JiakuoRecruiting
-
Istituto Ortopedico RizzoliCompletedPatellofemoral DislocationItaly
-
Hospices Civils de LyonCompletedEpisodic Patellar DislocationFrance
-
Nik ŽlakUniversity of Ljubljana; University of Ljubljana, Faculty of MedicineEnrolling by invitationPatellar DislocationSlovenia
-
Hospital for Special Surgery, New YorkChildren's Hospital Medical Center, Cincinnati; American Orthopaedic Society... and other collaboratorsRecruitingPatellofemoral Joint Dislocation | Patellar Dislocation | Patellar Instability | Patellofemoral Dislocation | Patellofemoral Disorder | Patellar Dislocation, RecurrentUnited States
-
Asbjorn AroenCompletedJoint InstabilityNorway
-
Banff Sport Medicine FoundationCONMED CorporationRecruitingPatellofemoral DislocationCanada