Knee Arthroscopy Cohort Southern Denmark (KACS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Southern Denmark
Sponsor:
Collaborators:
Department of Orthopedics and Traumatology, Odense University Hospital, Odense, Denmark
Sygehus Lillebaelt
Department of Orthopedics and Traumatology, Odense University Hospital, Svendborg, Denmark.
Information provided by (Responsible Party):
Jonas Bloch Thorlund, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01871272
First received: June 3, 2013
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Meniscus Injury
Knee Osteoarthritis
Procedure: Arthroscopic Meniscus Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Knee Arthroscopy Cohort Southern Denmark (KACS)

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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. ] [ Designated as safety issue: No ]
    Generic health survey questionnaire.

  • Patient Acceptable Symptom State (PASS) [ Time Frame: At 12 weeks and 52 weeks follow-up. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Global perceived effect (GPE) [ Time Frame: At 12 weeks and 52 weeks follow-up. ] [ Designated as safety issue: No ]
    Questions regarding global perceived effect (GPE) to explore minimal clinical important change in patient-reported outcomes.


Estimated Enrollment: 500
Study Start Date: February 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Meniscus Injury Patients
Patients having surgery for a meniscal tear.
Procedure: Arthroscopic Meniscus Surgery
Surgery to the meniscus - resection or repair.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01871272

Contacts
Contact: Jonas B Thorlund, PhD 6550 3894 ext +45 jthorlund@health.sdu.dk

Locations
Denmark
Department of Orthopedics, Lillebaelt Hospital Recruiting
Kolding, Southern Denmark, Denmark, 6000
Contact: Nis Nissen, MD       Nis.Nissen@rsyd.dk   
Department of Orthopedics and Traumatology, Odense University Hospital Recruiting
Odense, Southern Denmark, Denmark, 5000
Contact: Uffe Jørgensen, MD       Uffe.Joergensen@rsyd.dk   
Department of Orthopedics and Traumatology, Odense University Hospital Recruiting
Svendborg, Southern Denmark, Denmark, 5700
Contact: Jens C Pørneki, MD       poerneki@yahoo.com   
Department of Orthopedics, Lillebaelt Hospital Recruiting
Vejle, Southern Denmark, Denmark, 7100
Contact: Jeppe Schjerning, MD       Jeppe.Schjerning@rsyd.dk   
Sponsors and Collaborators
University of Southern Denmark
Department of Orthopedics and Traumatology, Odense University Hospital, Odense, Denmark
Sygehus Lillebaelt
Department of Orthopedics and Traumatology, Odense University Hospital, Svendborg, Denmark.
Investigators
Principal Investigator: Jonas B Thorlund, PhD Department of Sports Science and Clinical Biomechanics, University of Southern Denmark
  More Information

No publications provided

Responsible Party: Jonas Bloch Thorlund, Assistant Professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01871272     History of Changes
Other Study ID Numbers: 2012-41-1411, #12-125457, #12/6334
Study First Received: June 3, 2013
Last Updated: June 6, 2013
Health Authority: Denmark: The Regional Scientific Ethical Committee for South Denmark

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014