The Munich Knee Questionnaire - Development and Validation (MKQ)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Chlodwig Kirchhoff, Technische Universität München
ClinicalTrials.gov Identifier:
NCT01950208
First received: September 15, 2013
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

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
Knee Injury

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Munich Knee Questionnaire (MKQ) [ Time Frame: up to 6 weeks starting from onset of symptoms ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The self-assessment of the Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: up to 6 weeks starting from onset of symptoms ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • The International Knee Documentation Committee (IKDC) [ Time Frame: up to 6 weeks starting from onset of symptoms ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: August 2012
Study Completion Date: April 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
knee pain
patients suffering from 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

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
Study First Received: September 15, 2013
Last Updated: September 20, 2013
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by Technische Universität München:
Assessment

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

ClinicalTrials.gov processed this record on July 20, 2014