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
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Condition or disease | Intervention/treatment |
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Meniscus Injury Knee Osteoarthritis | Procedure: Arthroscopic Meniscus Surgery |
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 |

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

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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 |
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

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
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 |
Principal Investigator: | Jonas B Thorlund, PhD | Department of Sports Science and Clinical Biomechanics, University of Southern Denmark |
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 |
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 |
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |