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Knee Arthroscopy Cohort Southern Denmark (KACS) (KACS)

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ClinicalTrials.gov Identifier: NCT01871272
Recruitment Status : Completed
First Posted : June 6, 2013
Last Update Posted : June 30, 2015
Sponsor:
Collaborators:
Odense University Hospital
Lillebaelt Hospital, Kolding and Vejle, Denmark
Information provided by (Responsible Party):
Jonas Bloch Thorlund, University of Southern Denmark

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Meniscus Injury Knee Osteoarthritis Procedure: Arthroscopic Meniscus Surgery

Study Design
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Study Type : Observational
Actual Enrollment : 491 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Knee Arthroscopy Cohort Southern Denmark (KACS)
Study Start Date : February 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Meniscus Injury Patients
Patients having surgery for a meniscal tear.
 Procedure: Arthroscopic Meniscus Surgery
Surgery to the meniscus - resection or repair.


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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".

  3. 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:
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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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
Lillebaelt Hospital, Kolding and Vejle, Denmark
Investigators
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Principal Investigator: Jonas B Thorlund, PhD Department of Sports Science and Clinical Biomechanics, University of Southern Denmark
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jonas Bloch Thorlund, Associate Professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01871272    
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 Posted: June 6, 2013    Key Record Dates
Last Update Posted: June 30, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases