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The Munich Knee Questionnaire - Development and Validation (MKQ)

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ClinicalTrials.gov Identifier: NCT01950208
Recruitment Status : Completed
First Posted : September 25, 2013
Last Update Posted : September 25, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Knee Injury

Detailed 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.

Study Design

Study Type : Observational
Actual Enrollment : 105 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Munich Knee Questionnaire (MKQ) - Development and Validation of a New Patient-reported Outcome Measurement Tool in Knee Surgery
Study Start Date : August 2012
Primary Completion Date : October 2012
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
knee pain
patients suffering from knee injury


Outcome Measures

Primary Outcome Measures :
  1. Munich Knee Questionnaire (MKQ) [ Time Frame: up to 6 weeks starting from onset of symptoms ]

Secondary Outcome Measures :
  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 Outcome Measures:
  1. The International Knee Documentation Committee (IKDC) [ Time Frame: up to 6 weeks starting from onset of symptoms ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
all patients with knee pain
Criteria

Inclusion Criteria:

  • all patients presenting with knee pain

Exclusion Criteria:

  • no exclusion
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950208


Locations
Germany
Klinik und Poliklinik für Unfallchirurgie
Munich, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Investigators
Principal Investigator: Chlodwig Kirchhoff, MD Technische Universität München
More Information

Additional Information:
Responsible Party: Dr. Chlodwig Kirchhoff, PD Dr. med., Technische Universität München
ClinicalTrials.gov Identifier: NCT01950208     History of Changes
Other Study ID Numbers: Beiromat_01
Kirchhoff_Beiromat ( Registry Identifier: Kirchhoff_Beiromat )
First Posted: September 25, 2013    Key Record Dates
Last Update Posted: September 25, 2013
Last Verified: September 2013

Keywords provided by Dr. Chlodwig Kirchhoff, Technische Universität München:
Assessment

Additional relevant MeSH terms:
Knee Injuries
Leg Injuries
Wounds and Injuries