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Nurse Led Follow-up After Total Knee Arthroplasty (NFTKA)

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ClinicalTrials.gov Identifier: NCT01771315
Recruitment Status : Completed
First Posted : January 18, 2013
Last Update Posted : June 3, 2015
University Hospital, Gentofte, Copenhagen
Information provided by (Responsible Party):
Birte Oestergaard, University of Southern Denmark

Brief Summary:
The aim of this study is to determine the effect of nurse led follow-up following total knee arthroplasty in regard to physical function, health related quality of life and self-efficacy.

Condition or disease Intervention/treatment
Osteoarthritis Behavioral: Telephone follow-up

Detailed Description:
Due to shorter hospitalization the patients early have to be responsible for their own rehabilitation. However, the patients experience a variety of health related problems in the rehabilitations period following total knee arthroplasty and they have difficulties transferring health related information to their home settings. Nurse led follow-up in the early rehabilitation period might improve the health status of the patients by improving their knowledge and skills to handle health related problems. No studies found has investigated the effect of nurse led follow-up in form of telephone call following total knee arthroplasty.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Nurse Led Follow-up After Total Knee Arthroplasty - a Randomized Trial
Study Start Date : January 2013
Primary Completion Date : November 2014
Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: telephone follow-up
Nurse led follow-up in form of consultation by telephone 4 days and 2weeks after discharge, respectively as a supplement to conventional admission course.
Behavioral: Telephone follow-up
The consultation is structured by predefined themes relevant for identifying health related problems in regard to illness to give adequate education and counseling. The form of each consultation will vary according to the individual needs of the patients.
No Intervention: Usual treatment
All patients follow conventional admission course which implies preoperative seminar and a discharge planning consultation on the day of discharge. The patients are discharged to home, referred to physiotherapy in the community and a scheduled follow-up by the surgeon after 3 month in the orthopedic outpatient clinic.

Primary Outcome Measures :
  1. Change in physical function assessed by ≥ 12 points in physical function score in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index [ Time Frame: 3 days, 1, 3, 6 and 12 months post-surgery ]
    The WOMAC Index is disease specific measuring health status om three subscales: pain, stiffness and physical function

Secondary Outcome Measures :
  1. Change in the pain and stiffness score in WOMAC Index [ Time Frame: 3 days, 1, 3, 6 and 12 months post-surgery ]
  2. Changes in all scores in the subscales in Medical Outcomes Study Short Form (SF-36) [ Time Frame: 3 days, 1, 3, 6 and 12 months post-surgery ]
    A generic measure of health related quality of life

  3. Change in the score in the General Self-Efficacy Scale [ Time Frame: 3 days, 1, 3 and 6 months post-surgery ]
    An unidimensional measure of general self-efficacy.

  4. Number of acute visits to the orthopedic outpatient clinic [ Time Frame: 3 days, 1, 3, 6 anf 12 months post-surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • primary first-time total knee arthroplasty due to osteoarthrosis
  • followed conventional admission course and discharged ≤ 4 days after surgery
  • understand and talk Danish
  • signed informed consent

Exclusion Criteria:

  • in terminal phase of another serious illness such as i.e. cancer with expected lifetime less than 6 months
  • previous total hip replacement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771315

University Hospital Gentofte
Hellerup, Gentofte, Denmark, 2900
Sponsors and Collaborators
University of Southern Denmark
University Hospital, Gentofte, Copenhagen
Principal Investigator: Kirsten Szöts University Hospital Gentofte

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Birte Oestergaard, Associate professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01771315     History of Changes
Other Study ID Numbers: UNR-2013112-4
R108-A2423 ( Other Grant/Funding Number: The Danish Rheumatism Association )
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015

Keywords provided by Birte Oestergaard, University of Southern Denmark:
total knee arthroplasty
telephone follow-up
physical function
health related quality of life

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases