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Balance After Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04681404
Recruitment Status : Recruiting
First Posted : December 23, 2020
Last Update Posted : February 1, 2021
Sponsor:
Collaborator:
Kepler University Hospital
Information provided by (Responsible Party):
Christian Mittermaier, Johannes Kepler University of Linz

Study Description
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Brief Summary:
Evaluation of patients before and after knee arthroplasty regarding balance, function and quality of life. Comparison of total and unicompartmental knee arthroplasty. Comparison of the primary outcome parameter and selected secondary outcome parameters to healthy controls.

Condition or disease Intervention/treatment Phase
Postural Balance Knee Arthroplasty Quality of Life Procedure: Knee Arthroplasty Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Assessment of Balance, Function and Quality of Life in Patients Before and After Knee Replacement
Actual Study Start Date : January 11, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Total Knee Arthroplasty (TKA)
Patients intended to undergo surgery for total knee arthroplasty
 Procedure: Knee Arthroplasty
Comparison of TKA, UKA and healthy controls in relation to balance, function and QOL
Active Comparator: Unicompartmental Knee Arthroplasty (UKA)
Patients intended to undergo surgery for unicompartmental knee arthroplasty
 Procedure: Knee Arthroplasty
Comparison of TKA, UKA and healthy controls in relation to balance, function and QOL
No Intervention: Healthy Control


Outcome Measures
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Primary Outcome Measures :
  1. Center of pressure track (COPT) [ Time Frame: Before surgery ]
    Posturographic Parameter

  2. Center of pressure track (COPT) [ Time Frame: Day 3-7 after surgery ]
    Posturographic Parameter

  3. Center of pressure track (COPT) [ Time Frame: 3 months after surgery ]
    Posturographic Parameter

  4. Center of pressure track (COPT) [ Time Frame: 1 year after surgery ]
    Posturographic Parameter


Secondary Outcome Measures :
  1. Functional reach test [ Time Frame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery ]
  2. Timed up and go - test [ Time Frame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery ]
  3. Knee Injury and Osteoarthritis Outcome Score [ Time Frame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery ]
    Scale: Points, Minimum: 0, Maximum: 100, higher score means better outcome

  4. EQ-5D - Score [ Time Frame: Before surgery; 1 year after surgery ]
    Scale: Points, Minimum: 1, Maximum: <0, higher score means better outcome

  5. 10 m Walking test [ Time Frame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery ]
  6. WOMAC Score [ Time Frame: Before surgery; 1 year after surgery, higher score means better outcome ]
    Scale: Points, Minimum: 0, Maximum: 240, higher score means worse outcome

  7. Forgotten Joint Score [ Time Frame: Before surgery; 1 year after surgery ]
    Scale: Points, Minimum: 0, Maximum: 100, higher score means better outcome

  8. Oxford Knee Score [ Time Frame: Before surgery; 1 year after surgery ]
    Scale: Points, Minimum: 12, Maximum: 60, higher score means worse outcome

  9. Knee Society Score [ Time Frame: Before surgery; 1 year after surgery ]
    Scale: Points, Minimum: 0, Maximum: 100, higher score means better outcome

  10. The University of California at Los Angeles Activity Score [ Time Frame: Before surgery; 1 year after surgery ]
    Scale: Points, Minimum: 1, Maximum: 10, higher score means better outcome

  11. Area of Sway [ Time Frame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery ]
    Posturographic Parameter

  12. Frequency of Sway [ Time Frame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery ]
    Posturographic Parameter

  13. Harmony Index [ Time Frame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery ]
    Posturographic Parameter

  14. Stability energy [ Time Frame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery ]
    Posturographic Parameter

  15. Movement control [ Time Frame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery ]
    Posturographic Parameter

  16. Feedback (visual, somatosensoric, vestibular) [ Time Frame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery ]
    Posturographic Parameter

  17. Weight Distribution Index [ Time Frame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery ]
    Posturographic Parameter

  18. Fulfillment of Tests [ Time Frame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery ]
    Posturographic Parameter


Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary gonarthrosis
  • planned TKA or UKA
  • adequate cognitive and lingual competence
  • informed consent

Exclusion Criteria:

  • TKA or UKA revision
  • Surgery after trauma
  • Rheumatic disease
  • Neurologic disease
  • previous arthroplasty of the lower extremity (<9 months)
  • cardiovascular disease
  • restricted weight bearing of the lower extremity after surgery
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04681404


Contacts
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Contact: Christian Mittermaier, Dr +43 5 7680 83 ext 73779 christian.mittermaier@kepleruniklinikum.at

Locations
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Austria
Kepler University Hospital Recruiting
Linz, Austria, 4020
Contact: Christian Mittermaier, M.D.       christian.mittermaier@kepleruniklinikum.at   
Sponsors and Collaborators
Johannes Kepler University of Linz
Kepler University Hospital
Investigators
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Principal Investigator: Christian Mittermaier, Dr Kepler University Hospital
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Christian Mittermaier, Christian Mittermaier, MD, Johannes Kepler University of Linz
ClinicalTrials.gov Identifier: NCT04681404    
Other Study ID Numbers: PMR_Knee TKA 001
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: February 1, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No