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RecruitingNCT06061367Updated Oct 30, 2023

Muscles Strength and Gait Parameteres After TKA

An observational study in Arthritis Knee, Gait Biomechanics and Total Knee Arthroplasty, sponsored by Medical University of Warsaw. Recruiting at 1 site in Poland. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2023-10-30.

Sponsored by Medical University of Warsaw · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

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03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 791 observational studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Medical University of Warsaw is the lead sponsor of 316 studies on the registry; 87 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients over 50 years old with knee osteoarthritis

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

  2. 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).

    Time frame: 6 months

  3. 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).

    Time frame: 6 months

  4. 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).

    Time frame: 6 months

  5. 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).

    Time frame: 6 months

  6. Physical function assessment based on standardized test

    Analysis of pre- and postoperative physical function on the basis of Up and Go test.

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 6 months

  2. 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.

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Department of Orthopedics and Rehabilitation, Medical University of Warsaw
    Warsaw, 04-749, Poland
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06061367
Lead sponsor
Medical University of Warsaw
Responsible party
Artur Stolarczyk (Professor, Medical University of Warsaw) — Principal investigator
First posted
Sep 29, 2023
Start date
Sep 30, 2023
Primary completion
Jul 31, 2024 (estimated)
Completion
Dec 1, 2024 (estimated)
Last update
Oct 30, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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