Balance After Knee Arthroplasty

Assessment of Balance, Function and Quality of Life in Patients Before and After Knee Replacement

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Knee Arthroplasty; Postural Balance
• Intervention / Treatment: Procedure: Knee Arthroplasty

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christian Mittermaier, Dr; Phone Number: 73779 +43 5 7680 83; Email: christian.mittermaier@kepleruniklinikum.at

Study Locations

• Austria
  • Linz, Austria, 4020
    • Recruiting
    • Kepler University Hospital
    • Contact: Christian Mittermaier, M.D.; Email: christian.mittermaier@kepleruniklinikum.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Healthy Control
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Scale: Points, Minimum: 0, Maximum: 100, higher score means better outcome	Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
EQ-5D - Score	Scale: Points, Minimum: 1, Maximum: <0, higher score means better outcome	Before surgery; 1 year after surgery
10 m Walking test		Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
WOMAC Score	Scale: Points, Minimum: 0, Maximum: 240, higher score means worse outcome	Before surgery; 1 year after surgery, higher score means better outcome
Forgotten Joint Score	Scale: Points, Minimum: 0, Maximum: 100, higher score means better outcome	Before surgery; 1 year after surgery
Oxford Knee Score	Scale: Points, Minimum: 12, Maximum: 60, higher score means worse outcome	Before surgery; 1 year after surgery
Knee Society Score	Scale: Points, Minimum: 0, Maximum: 100, higher score means better outcome	Before surgery; 1 year after surgery
The University of California at Los Angeles Activity Score	Scale: Points, Minimum: 1, Maximum: 10, higher score means better outcome	Before surgery; 1 year after surgery
Area of Sway	Posturographic Parameter	Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Frequency of Sway	Posturographic Parameter	Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Harmony Index	Posturographic Parameter	Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Stability energy	Posturographic Parameter	Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Movement control	Posturographic Parameter	Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Feedback (visual, somatosensoric, vestibular)	Posturographic Parameter	Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Weight Distribution Index	Posturographic Parameter	Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Fulfillment of Tests	Posturographic Parameter	Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery

Collaborators and Investigators

• Sponsor: Johannes Kepler University of Linz
• Collaborators: Kepler University Hospital
• Investigators: Principal Investigator: Christian Mittermaier, Dr, Kepler University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: February 12, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PMR_Knee TKA 001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No