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Completed

NCT Number: NCT01771315

Nurse Led Follow-up After Total Knee Arthroplasty

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Gentofte

Hellerup, Gentofte, 2900, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Telephone follow-up

Behavioral

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • University Hospital, Gentofte, Copenhagen

Registry information

Official study title

Nurse Led Follow-up After Total Knee Arthroplasty - a Randomized Trial

Acronym: NFTKA

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 18, 2013
Registry last updated
Jun 3, 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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