Muscles Strength and Gait Parameteres After TKA

NCT06061367 | Unknown

• 1 other identifier: WarsawMU/MUSABGP
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthritis Knee; Gait Biomechanics; Total Knee Arthroplasty; Muscle Strength; Osteoarthritis

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Patient-reported outcome - Oxford Knee Score

  6 months

• Patient-reported outcome - Forgotten Joint Score

  6 months

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over 50 years old with knee osteoarthritis

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Orthopedics and Rehabilitation, Medical University of Warsaw

Warsaw, 04-749, Poland

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 29, 2023
• First Posted: September 29, 2023
• Study Start: September 30, 2023
• Primary Completion: July 31, 2024
• Study Completion: December 1, 2024
• Last Updated: October 30, 2023

Record last verified: 2023-10

Locations

PL (1)