Balance After Knee Arthroplasty
Assessment of Balance, Function and Quality of Life in Patients Before and After Knee Replacement
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2020
CompletedFirst Posted
Study publicly available on registry
December 23, 2020
CompletedStudy Start
First participant enrolled
January 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedMarch 30, 2023
March 1, 2023
2.3 years
February 12, 2020
March 29, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
Center of pressure track (COPT)
Posturographic Parameter
Before surgery
Center of pressure track (COPT)
Posturographic Parameter
Day 3-7 after surgery
Center of pressure track (COPT)
Posturographic Parameter
3 months after surgery
Center of pressure track (COPT)
Posturographic Parameter
1 year after surgery
Secondary Outcomes (18)
Functional reach test
Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Timed up and go - test
Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Knee Injury and Osteoarthritis Outcome Score
Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
EQ-5D - Score
Before surgery; 1 year after surgery
10 m Walking test
Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
- +13 more secondary outcomes
Study Arms (3)
Total Knee Arthroplasty (TKA)
ACTIVE COMPARATORPatients intended to undergo surgery for total knee arthroplasty
Unicompartmental Knee Arthroplasty (UKA)
ACTIVE COMPARATORPatients intended to undergo surgery for unicompartmental knee arthroplasty
Healthy Control
NO INTERVENTIONInterventions
Comparison of TKA, UKA and healthy controls in relation to balance, function and QOL
Eligibility Criteria
You may qualify if:
- Primary gonarthrosis
- planned TKA or UKA
- adequate cognitive and lingual competence
- informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johannes Kepler University of Linzlead
- Kepler University Hospitalcollaborator
Study Sites (1)
Kepler University Hospital
Linz, 4020, Austria
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian Mittermaier, Dr
Kepler University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Christian Mittermaier, MD
Study Record Dates
First Submitted
February 12, 2020
First Posted
December 23, 2020
Study Start
January 11, 2021
Primary Completion
May 1, 2023
Study Completion
December 1, 2023
Last Updated
March 30, 2023
Record last verified: 2023-03