Knee Arthroscopy Cohort Southern Denmark (KACS)

Knee Osteoarthritis Clinical Trial

— KACS  

Official title:

Knee Arthroscopy Cohort Southern Denmark (KACS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01871272
• Other study ID #: 2012-41-1411
• Secondary ID: #12-125457#12/63
• Status: Completed
• Phase: N/A
• First received: June 3, 2013
• Last updated: June 29, 2015
• Start date: February 2013
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Scientific Ethical Committee for South Denmark
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 491
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Meniscus Injury
• Osteoarthritis, Knee

Intervention

Procedure:
• Arthroscopic Meniscus Surgery
Surgery to the meniscus - resection or repair.

Locations

Country	Name	City	State
Denmark	Department of Orthopedics, Lillebaelt Hospital	Kolding	Southern Denmark
Denmark	Department of Orthopedics and Traumatology, Odense University Hospital	Odense	Southern Denmark
Denmark	Department of Orthopedics and Traumatology, Odense University Hospital	Svendborg	Southern Denmark
Denmark	Department of Orthopedics, Lillebaelt Hospital	Vejle	Southern Denmark

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern Denmark	Lillebaelt Hospital, Kolding and Vejle, Denmark, Odense University Hospital, Odense, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Thorlund JB, Christensen R, Nissen N, Jørgensen U, Schjerning J, Pørneki JC, Englund M, Lohmander LS. Knee Arthroscopy Cohort Southern Denmark (KACS): protocol for a prospective cohort study. BMJ Open. 2013 Oct 14;3(10):e003399. doi: 10.1136/bmjopen-2013-003399. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Global perceived effect (GPE)	Questions regarding global perceived effect (GPE) to explore minimal clinical important change in patient-reported outcomes.	At 12 weeks and 52 weeks follow-up.	No
Primary	Knee Injury and Osteoarthritis Outcome Score (KOOS)	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.	PRE surgery (assessed 1-14 days prior to surgery) and at 12 weeks and 52 weeks follow-up	No
Secondary	Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)	Generic health survey questionnaire.	PRE surgery (assessed 1-14 days prior to surgery) and at 12 weeks and 52 weeks follow-up.	No
Secondary	Patient Acceptable Symptom State (PASS)	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".	At 12 weeks and 52 weeks follow-up.	No
Secondary	Treatment failure (TF)	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).	At 12 weeks and 52 weeks follow-up.	No