Knee Arthroscopy Cohort Southern Denmark (KACS) (KACS)

June 29, 2015 updated by: Jonas Bloch Thorlund, University of Southern Denmark
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

491

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Southern Denmark
      • Kolding, Southern Denmark, Denmark, 6000
        • Department of Orthopedics, Lillebaelt Hospital
      • Odense, Southern Denmark, Denmark, 5000
        • Department of Orthopedics and Traumatology, Odense University Hospital
      • Svendborg, Southern Denmark, Denmark, 5700
        • Department of Orthopedics and Traumatology, Odense University Hospital
      • Vejle, Southern Denmark, Denmark, 7100
        • Department of Orthopedics, Lillebaelt Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
PRE surgery (assessed 1-14 days prior to surgery) and at 12 weeks and 52 weeks follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
PRE surgery (assessed 1-14 days prior to surgery) and at 12 weeks and 52 weeks follow-up.
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".
At 12 weeks and 52 weeks follow-up.
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).
At 12 weeks and 52 weeks follow-up.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 12 weeks and 52 weeks follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

Odense University Hospital
Lillebaelt Hospital, Kolding and Vejle, Denmark

Investigators

  • Principal Investigator: Jonas B Thorlund, PhD, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

June 3, 2013

First Submitted That Met QC Criteria

June 3, 2013

First Posted (Estimate)

June 6, 2013

Study Record Updates

Last Update Posted (Estimate)

June 30, 2015

Last Update Submitted That Met QC Criteria

June 29, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

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)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Knee Osteoarthritis

Clinical Trials on Arthroscopic Meniscus Surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe