Clinical trial NCT04681404: Balance After Knee Arthroplasty
Official title: Assessment of Balance, Function and Quality of Life in Patients Before and After Knee Replacement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postural Balance
Knee Arthroplasty
Quality of Life
Lead sponsor: Johannes Kepler University of Linz
Sponsor class: OTHER
Collaborators: name: Kepler University Hospital
First posted: 2020-12-23
Enrollment: 150
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Center of pressure track (COPT)
timeFrame: Before surgery
measure: Center of pressure track (COPT)
timeFrame: Day 3-7 after surgery
measure: Center of pressure track (COPT)
timeFrame: 3 months after surgery
measure: Center of pressure track (COPT)
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Functional reach test
timeFrame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
measure: Timed up and go - test
timeFrame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
measure: EQ-5D - Score
timeFrame: Before surgery; 1 year after surgery
measure: 10 m Walking test
timeFrame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
measure: WOMAC Score
timeFrame: Before surgery; 1 year after surgery, higher score means better outcome
measure: Forgotten Joint Score
timeFrame: Before surgery; 1 year after surgery
measure: Oxford Knee Score
timeFrame: Before surgery; 1 year after surgery
measure: Knee Society Score
timeFrame: Before surgery; 1 year after surgery
measure: The University of California at Los Angeles Activity Score
timeFrame: Before surgery; 1 year after surgery
measure: Area of Sway
timeFrame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
measure: Frequency of Sway
timeFrame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
measure: Harmony Index
timeFrame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
measure: Stability energy
timeFrame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
measure: Movement control
timeFrame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
measure: Feedback (visual, somatosensoric, vestibular)
timeFrame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
measure: Weight Distribution Index
timeFrame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
measure: Fulfillment of Tests
timeFrame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler University Hospital
Study officials:
affiliation: Kepler University Hospital
name: Christian Mittermaier, Dr
role: PRINCIPAL_INVESTIGATOR
References: