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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01950208
Other study ID # Beiromat_01
Secondary ID Kirchhoff_Beirom
Status Completed
Phase N/A
First received September 15, 2013
Last updated September 20, 2013
Start date August 2012
Est. completion date April 2013

Study information

Verified date September 2013
Source Technische Universität München
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Ministry of Education and Research
Study type Observational

Clinical Trial Summary

the purpose of this study is to develop and validate a new PRO measurement tool for the knee joint, the so-called Munich Knee Questionnaire (MKQ), allowing for a qualitative self-assessment of the Knee Injury and Osteoarthritis Outcome Score (KOOS), the International Knee Documentation Committee (IKDC), the Lysholm Knee Score, the Western Ontario Meniscal Evaluation Tool (WOMET) and the Tegner Score.


Description:

A systematic review of the literature was performed to identify valid and commonly used instruments regarding follow-up examinations in the field of knee surgery. PubMed.gov was searched for knee-specific terms (knee, surgery, joint, lower extremity) combined with psychometric (follow-up, validity, reliability, responsiveness) and instrument-specific terms (self-reported, patient-based, measurement tool, outcome measure, questionnaire). Hence, the KOOS, IKDC, Lysholm, WOMET and Tegner Score were identified as frequent used and valid measurement tools in the evaluation of knee joint function. After analysing each single question of these questionnaires for coincidences regarding measurement of specific knee function, the identified items were condensed to one single question for each specific item. Typical functional abilities (flexion/extension) were depicted as photographs. Thus, one single questionnaire with a total of 33 questions divided in five subscales (Symptoms, Pain, Work and Activities of daily life, Sports and Recreational activities, Physical function and knee related Quality of Life), was created.


Recruitment information / eligibility

Status Completed
Enrollment 105
Est. completion date April 2013
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- all patients presenting with knee pain

Exclusion Criteria:

- no exclusion

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Klinik und Poliklinik für Unfallchirurgie Munich Bavaria

Sponsors (1)

Lead Sponsor Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other The International Knee Documentation Committee (IKDC) up to 6 weeks starting from onset of symptoms No
Primary Munich Knee Questionnaire (MKQ) up to 6 weeks starting from onset of symptoms No
Secondary The self-assessment of the Knee Injury and Osteoarthritis Outcome Score (KOOS) up to 6 weeks starting from onset of symptoms No
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