Arthritis KneeNCT06061367
Muscles Strength and Gait Parameteres After TKA
An observational study of Arthritis Knee and Gait Biomechanics, run by Medical University of Warsaw at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Arthritis Knee, Gait Biomechanics, Total Knee Arthroplasty
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 30 Sep 2023to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Adult, Older adult
Study population: Patients over 50 years old with knee osteoarthritis
Who may be able to join
- III° or IV° grade knee osteoarthritis
- Age over 50
- Patients with signed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Orthopedics and Rehabilitation, Medical University of Warsaw
Warsaw, 04-749
Marcin Łapiński, MD, 664011943 ext. +48, marcin.lapinski@wum.edu.pl
About this study
Official title: 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.
- Conditions
- Arthritis Knee, Gait Biomechanics, Total Knee Arthroplasty, Muscle Strength, Osteoarthritis
- Medical subject headings
- Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 6 months
Physical function assessment based on standardized test
Analysis of pre- and postoperative physical function on the basis of Up and Go test.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start30 Sep 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis KneeStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Artur Stolarczyk, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061367
- Sponsor's protocol ID
- WarsawMU/MUSABGP
- Status last verified
- Oct 2023
- First submitted
- 29 Jul 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Lower Extremity Muscles Strength on Physical Function, Biomechanical Gait Parameters and Reported Outcome After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06061367
- Acronym / sponsor ID
- WarsawMU/MUSABGP
- Conditions
- Arthritis Knee, Gait Biomechanics, Total Knee Arthroplasty, Muscle Strength, Osteoarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 30 Sep 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients over 50 years old with knee osteoarthritis
Key inclusion criteria (3 listed)
- III° or IV° grade knee osteoarthritis
- Age over 50
- Patients with signed consent
Key exclusion criteria (7 listed)
- Undergone total hip replacement
- Previous femur fracture in anamnesis
- Undergone corrective osteotomy
- Active/ Chronic neoplastic disease
- Significant deformation of lower limb axis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Muscle strength measurement with a use of dynamometer
Time frame: 6 months
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.
Gait biomechanics analysis - step length
Time frame: 6 months
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).
Gait biomechanics analysis - gait speed
Time frame: 6 months
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).
Gait biomechanics analysis - phases of gait
Time frame: 6 months
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).
Gait biomechanics analysis - step duration
Time frame: 6 months
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).
Physical function assessment based on standardized test
Time frame: 6 months
Analysis of pre- and postoperative physical function on the basis of Up and Go test.
2 secondary outcomes
Patient-reported outcome - Oxford Knee Score
Time frame: 6 months
Patient-reported outcome - Forgotten Joint Score
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Orthopedics and Rehabilitation, Medical University of Warsaw
Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis Knee and Gait Biomechanics, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength measurement with a use of dynamometer (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.