Muscles Strength and Gait Parameteres After TKA

Influence of Lower Extremity Muscles Strength on Physical Function, Biomechanical Gait Parameters and Reported Outcome After Total Knee Arthroplasty

Total Knee Arthroplasty (TKA) is actually the most effective treatment option for patients with end-stage osteoarthritis (OA). However, nearly 20% of patients who underwent TKA remain unsatisfied with their clinical outcome. Investigating modifiable factors that limit knee functioning following TKA we may notice the significance of lower limb muscles strength. Gait pattern is also affected by OA, as arthritic knee joint cannot provide proper range of motion (ROM) and stability.Therefore any deviation in biomechanics should be noticed and analyzed. After TKA patients' physical function may change, but the study should be conducted to prove whether it improves or not. Patient-reported outcome defined by OKS (Oxford Knee Score) and FJS (Forgotten Joint Score) questionnaires will be evaluated.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis; Total Knee Arthroplasty; Muscle Strength; Arthritis Knee; Gait Biomechanics

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 04-749
    • Recruiting
    • Department of Orthopedics and Rehabilitation, Medical University of Warsaw
    • Contact: Marcin Łapiński, MD; Phone Number: +48 664011943; Email: marcin.lapinski@wum.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients over 50 years old with knee osteoarthritis

Description

Inclusion Criteria:

• III° or IV° grade knee osteoarthritis
• Age over 50
• Patients with signed consent

Exclusion Criteria:

• Undergone total hip replacement
• Previous femur fracture in anamnesis
• Undergone corrective osteotomy
• Active/ Chronic neoplastic disease
• Significant deformation of lower limb axis
• Mental disorders
• Muscular disorders

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strength measurement with a use of dynamometer	Analysis of pre- and postoperative strength of lower limb muscles. Assessment of force [N] generated by knee flexors, knee extensors, hip adductors and hip abductors with a use of a hand-held dynamometer.	6 months
Gait biomechanics analysis - step length	Analysis of pre- and postoperative parameters of gait pattern and biomechanics with a use of Baiobit device (wearable motion analysis system). Subjected to the analysis will be the step length (in meters).	6 months
Gait biomechanics analysis - gait speed	Analysis of pre- and postoperative parameters of gait pattern and biomechanics with a use of Baiobit device (wearable motion analysis system). Subjected to the analysis will be the gait speed (metre per second).	6 months
Gait biomechanics analysis - phases of gait	Analysis of pre- and postoperative parameters of gait pattern and biomechanics with a use of Baiobit device (wearable motion analysis system). Subjected to the analysis will be the swing and the stance phase of gait (% of the gait cycle).	6 months
Gait biomechanics analysis - step duration	Analysis of pre- and postoperative parameters of gait pattern and biomechanics with a use of Baiobit device (wearable motion analysis system). Subjected to the analysis will be the duration of left and right step (in seconds).	6 months
Physical function assessment based on standardized test	Analysis of pre- and postoperative physical function on the basis of Up and Go test.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported outcome - Oxford Knee Score	Pre- and postoperative evaluation of Oxford Knee Score. Patients will be asked 12 closed-end questions. 5 possible answers to choose. The scoring system is from 0 to 4 for each answer. Total score ranges from 0 to 48, where 0 is the poorest outcome, and 48 is the best one.	6 months
Patient-reported outcome - Forgotten Joint Score	Pre- and postoperative evaluation of Forgotten Joint Score. The questionnaire is based on 12 questions. Total score ranges from 0 to 100. Higher score on the questionnaire, means better results were obtained.	6 months

Collaborators and Investigators

• Sponsor: Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 29, 2023
• First Submitted That Met QC Criteria: September 24, 2023
• First Posted (Actual): September 29, 2023

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: WarsawMU/MUSABGP

Drug and device information, study documents

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