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Knee Arthroscopy Cohort Southern Denmark (KACS) (KACS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01871272
First Posted: June 6, 2013
Last Update Posted: June 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Odense University Hospital, Odense, Denmark
Lillebaelt Hospital, Kolding and Vejle, Denmark
Information provided by (Responsible Party):
Jonas Bloch Thorlund, University of Southern Denmark
  Purpose
PURPOSE: To investigate the natural time course of patient-reported outcomes after meniscus surgery and identify factors associated with good and bad outcome after surgery.

Condition Intervention
Meniscus Injury Knee Osteoarthritis Procedure: Arthroscopic Meniscus Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Knee Arthroscopy Cohort Southern Denmark (KACS)

Resource links provided by NLM:


Further study details as provided by Jonas Bloch Thorlund, University of Southern Denmark:

Primary Outcome Measures:
  • Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: PRE surgery (assessed 1-14 days prior to surgery) and at 12 weeks and 52 weeks follow-up ]
    Knee specific questionnaire. All domains on the KOOS. Primary end point is change from PRE surgery (assessed 1-14 days prior to surgery) to 52 weeks follow-up.


Secondary Outcome Measures:
  • Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) [ Time Frame: PRE surgery (assessed 1-14 days prior to surgery) and at 12 weeks and 52 weeks follow-up. ]
    Generic health survey questionnaire.

  • Patient Acceptable Symptom State (PASS) [ Time Frame: At 12 weeks and 52 weeks follow-up. ]
    Dichotomous outcome (y/n) to the question: "Considering your knee function, do you feel that your current state is satisfactory? With knee function you should take into account all activities you have during your daily life, sport and recreational activities, your level of pain and other symptoms, and also your knee related quality of life".

  • Treatment failure (TF) [ Time Frame: At 12 weeks and 52 weeks follow-up. ]
    Patients replying "no" to the PASS question will also be asked to answer (y/n) the following question: "Would you consider your current state as being so unsatisfactory that you think the treatment has failed?". Patients replying, "yes" to the second question will be defined as experiencing "treatment failure" (TF).


Other Outcome Measures:
  • Global perceived effect (GPE) [ Time Frame: At 12 weeks and 52 weeks follow-up. ]
    Questions regarding global perceived effect (GPE) to explore minimal clinical important change in patient-reported outcomes.


Enrollment: 491
Study Start Date: February 2013
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Meniscus Injury Patients
Patients having surgery for a meniscal tear.
Procedure: Arthroscopic Meniscus Surgery
Surgery to the meniscus - resection or repair.

  Eligibility

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
Patients assigned for arthroscopy on suspicion of a meniscus tear in the period from February 1st 2013 to January 31st 2014 will be consecutively recruited to the KACS cohort from 4 different hospitals (Lillebaelt Hospital - Kolding and Vejle and Odense University Hospital - Odense and Svendborg) in the Region of Southern Denmark.
Criteria

Inclusion Criteria:

  • Assigned for arthroscopy on suspicion of a medial and/or lateral meniscus tear.
  • Age >18 years at time of recruitment
  • Having an email address
  • Able to read and understand Danish

Exclusion Criteria:

  • Patients who will or have previously undergone surgical reconstruction of the anterior or posterior cruciate ligament (ACL or PCL) in either knee
  • Fracture to the lower extremities (i.e. hip, leg or foot) in either leg within the last 6 months prior to recruitment
  • Not mentally able to reply to the questionnaire
  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): NCT01871272


Locations
Denmark
Department of Orthopedics, Lillebaelt Hospital
Kolding, Southern Denmark, Denmark, 6000
Department of Orthopedics and Traumatology, Odense University Hospital
Odense, Southern Denmark, Denmark, 5000
Department of Orthopedics and Traumatology, Odense University Hospital
Svendborg, Southern Denmark, Denmark, 5700
Department of Orthopedics, Lillebaelt Hospital
Vejle, Southern Denmark, Denmark, 7100
Sponsors and Collaborators
University of Southern Denmark
Odense University Hospital, Odense, Denmark
Lillebaelt Hospital, Kolding and Vejle, Denmark
Investigators
Principal Investigator: Jonas B Thorlund, PhD Department of Sports Science and Clinical Biomechanics, University of Southern Denmark
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jonas Bloch Thorlund, Associate Professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01871272     History of Changes
Other Study ID Numbers: 2012-41-1411
#12-125457 ( Other Grant/Funding Number: The Danish Council for Independent Research | Medical Sciences )
#12/6334 ( Other Grant/Funding Number: Region of Southern Denmark )
First Submitted: June 3, 2013
First Posted: June 6, 2013
Last Update Posted: June 30, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases