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Completed

NCT Number: NCT01871272

Knee Arthroscopy Cohort Southern Denmark (KACS)

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.

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Key information

Conditions

Meniscus Injury Arthritis Joint Diseases Knee Osteoarthritis Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Orthopedics, Lillebaelt Hospital, Kolding, Southern Denmark, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroscopic meniscus surgery

Procedure

Surgery to the meniscus - resection or repair.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Lillebaelt Hospital, Kolding and Vejle, Denmark
  • Odense University Hospital

Registry information

Acronym: KACS

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 6, 2013
Registry last updated
Jun 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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