NCT01495507

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)

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 20, 2011

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Last Updated

July 19, 2016

Status Verified

July 1, 2016

Enrollment Period

5.2 years

First QC Date

December 19, 2011

Last Update Submit

July 16, 2016

Conditions

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

Outcome Measures

Primary Outcomes (6)

  • Kujala Score

    1 year

  • KOOS (Knee Injury and Osteoarthritis Outcome Score)

    1 year

  • Marx Activity Scale

    1 year

  • SF-12 (Short - Form 12)

    1 year

  • VAS pain

    1 year

  • Lysholm Score

    1 year

Study Arms (1)

Patellofemoral Instability

Patients with diagnosis of patellofemoral instability receiving MPFL-reconstruction as part of the clinical routine

Procedure: MPFL- Reconstruction

Interventions

MPFL- ReconstructionPROCEDURE
Patellofemoral Instability

Eligibility Criteria

Age10 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with patellofemoral instability \& scheduled MPFL-reconstruction

You may qualify if:

  • german speaking
  • MPFL-reconstruction planed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. Orthop. Surgery, Medical Univ. Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Central Study Contacts

Michael C Liebensteiner, MD, PhD

CONTACT

+43 512 504 80547michael.liebensteiner@i-med.ac.at

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 19, 2011

First Posted

December 20, 2011

Study Start

November 1, 2011

Primary Completion

January 1, 2017

Last Updated

July 19, 2016

Record last verified: 2016-07

Locations

AU(1)