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Completed

NCT Number: NCT01950208

The Munich Knee Questionnaire - Development and Validation

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.

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Key information

Conditions

Knee Injury Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinik und Poliklinik für Unfallchirurgie

Munich, Bavaria, 81675, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all patients presenting with knee pain

Exclusion criteria

  • no exclusion

Treatment and study plan

Primary outcomes

  1. Munich Knee Questionnaire (MKQ)

    Time frame: up to 6 weeks starting from onset of symptoms

Secondary outcomes

  1. The self-assessment of the Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: up to 6 weeks starting from onset of symptoms

Other outcomes

  1. The International Knee Documentation Committee (IKDC)

    Time frame: up to 6 weeks starting from onset of symptoms

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

The Munich Knee Questionnaire (MKQ) - Development and Validation of a New Patient-reported Outcome Measurement Tool in Knee Surgery

Acronym: MKQ

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Sep 25, 2013
Registry last updated
Sep 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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