Muscles Strength and Gait Parameteres After TKA

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06061367
• Other study ID #: WarsawMU/MUSABGP
• Status: Recruiting
• Start date: September 30, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: October 2023
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2024
• Est. primary completion date: July 31, 2024
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis Knee
• Muscle Strength
• Osteoarthritis
• Total Knee Arthroplasty

Locations

Country	Name	City	State
Poland	Department of Orthopedics and Rehabilitation, Medical University of Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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