Knee Arthroscopy Cohort Southern Denmark (KACS)

Completed

• Conditions: Meniscus Injury; Knee Osteoarthritis
• Interventions: Procedure: Arthroscopic Meniscus Surgery

• Registration Number: NCT01871272
• Lead Sponsor: University of Southern Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-06-03
• Study First Submitted QC: 2013-06-03
• Study First Posted: 2013-06-06
• Status Verified: 2015-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2015-06-29
• Last Update Posted: 2015-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 491

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Meniscus Injury Patients	Arthroscopic Meniscus Surgery	Patients having surgery for a meniscal tear.

Primary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome Score (KOOS)	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

Name	Time	Method
Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)	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)	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)	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).

Trial Locations

Locations (2)

Department of Orthopedics and Traumatology, Odense University Hospital; 🇩🇰 Svendborg, Southern Denmark, Denmark

Department of Orthopedics, Lillebaelt Hospital; 🇩🇰 Vejle, Southern Denmark, Denmark