Arthroplasty, Replacement, KneeNCT05219396
The Comparison of Proprioception and Gait Function Among Different Rotational Designs in Knee Arthroplasty
An observational study of Arthroplasty, Replacement, Knee and Proprioception, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The symptoms of knee osteoarthritis include knee joint pain, impaired proprioception, and etc. Knee arthroplasty is commonly recommended for the patient with severe knee osteoarthritis to relieve pain and regain function. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Proprioception, Gait
- What is being tested?
- Knee arthroplasty
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2022to 24 Dec 2024
- How long will I take part?
- 6 Months
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Out patient department
Who may be able to join
- Diagnosed as knee joint osteoarthritis and will receive knee joint arthroplasty.
Who cannot join
- Already receiving a knee joint arthroplasty surgery
- Can not walk independently for 20 m
- Can not stand for 5 min
- With neurological degenerative disease
- Lower limb received any surgery within recent 2 years
Trial locations and contacts
1 site in 1 country.
About this study
The symptoms of knee osteoarthritis include knee joint pain, impaired proprioception, and etc. Knee arthroplasty is commonly recommended for the patient with severe knee osteoarthritis to relieve pain and regain function. But the effects of arthroplasty on the proprioception and gait performance, which were related to the risk of falling, were not fully understood. Recently, the concept of enhancing the rotational movement has been introduced into the design of the knee joint prosthesis for mimicking the kinematic performance of the healthy knee. However, study on the functional performance after using these rotational designed arthroplasties was still scarce. So, the purpose of this study aims to evaluate the differences in the proprioception, balance function and gait performance among different designs of the knee arthroplasties with mobile bearing (MB), medial congruent (MC) and posterior stabilized (PS) design. This study is divided into the retrospective and prospective parts.
Investigators will enroll the patients who already replaced their knee joint by one of the above knee arthroplasties for the retrospective part; other patients who plans to receive one of the above knee arthroplasties, twenty participants for each design and each part. The assessment of proprioception, balance function and gait performance will be performed before the knee arthroplasty, and followed at the post-surgery time points of six weeks and three months. The one-way ANOVA will be used to compare the group differences in the retrospective part, and the two-way mixed model ANOVA for the prospective part.
Ultimately, the results of this study could help to have better knowledge of the treatment effects from the different designed knee arthroplasties.
- Conditions
- Arthroplasty, Replacement, Knee, Proprioception, Gait, Balance
- Being tested
- Knee arthroplasty
- Keywords
- knee arthroplasty, rotational design, proprioception, balance function, gait performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee arthroplastyDevice
Your knee should be replaced with mobile bearing (MB), medial congruent (MC) and posterior stabilized (PS) design protheses.
| Study group | Role | What they receive |
|---|---|---|
| mobile bearing (MB) | Not described Receives: Device: Knee arthroplasty | |
| medial congruent (MC) | Not described Receives: Device: Knee arthroplasty | |
| posterior stabilized (PS) | Not described Receives: Device: Knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee joint proprioception
Degrees
Measured: Pre-operation
Knee joint proprioception
Degrees
Measured: Post-operation 6 weeks
Knee joint proprioception
Degrees
Measured: Post-operation 3 months
Postural stability index
Degrees
Measured: Pre-operation
Postural stability index
Degrees
Measured: Post-operation 6 weeks
Postural stability index
Degrees
Measured: Post-operation 3 months
Angle of foot during walking
Degrees
Measured: Pre-operation
Angle of foot during walking
Degrees
Measured: Post-operation 6 weeks
Angle of foot during walking
Degrees
Measured: Post-operation 3 months
Western Ontario and McMaster Universities Osteoarthritis Index, WOMAC
Scoring from 0 to 100, and higher scores mean a better outcome.
Measured: Pre-operation
Western Ontario and McMaster Universities Osteoarthritis Index, WOMAC
Scoring from 0 to 100, and higher scores mean a better outcome.
Measured: Post-operation 6 weeks
Western Ontario and McMaster Universities Osteoarthritis Index, WOMAC
Scoring from 0 to 100, and higher scores mean a better outcome.
Measured: Post-operation 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start1 Jan 2022
- Primary completion1 Jan 2022
- Study completion24 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219396
- Sponsor's protocol ID
- CMUH110-REC2-235
- Status last verified
- Jan 2025
- First submitted
- 19 Jan 2022
- Last updated
- 28 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Proprioception and Gait Function Among Different Rotational Designs in Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05219396
- Acronym / sponsor ID
- CMUH110-REC2-235
- Conditions
- Arthroplasty, Replacement, Knee, Proprioception, Gait, Balance
- Keywords
- knee arthroplasty, rotational design, proprioception, balance function, gait performance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 24 Dec 2024 (actual)
- First posted
- 2 Feb 2022 (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.
The symptoms of knee osteoarthritis include knee joint pain, impaired proprioception, and etc. Knee arthroplasty is commonly recommended for the patient with severe knee osteoarthritis to relieve pain and regain function. But the effects of arthroplasty on the proprioception and gait performance, which were related to the risk of falling, were not fully understood. Recently, the concept of enhancing the rotational movement has been introduced into the design of the knee joint prosthesis for mimicking the kinematic performance of the healthy knee. However, study on the functional performance after using these rotational designed arthroplasties was still scarce. So, the purpose of this study aims to evaluate the differences in the proprioception, balance function and gait performance among different designs of the knee arthroplasties with mobile bearing (MB), medial congruent (MC) and posterior stabilized (PS) design. This study is divided into the retrospective and prospective parts.
Investigators will enroll the patients who already replaced their knee joint by one of the above knee arthroplasties for the retrospective part; other patients who plans to receive one of the above knee arthroplasties, twenty participants for each design and each part. The assessment of proprioception, balance function and gait performance will be performed before the knee arthroplasty, and followed at the post-surgery time points of six weeks and three months. The one-way ANOVA will be used to compare the group differences in the retrospective part, and the two-way mixed model ANOVA for the prospective part.
Ultimately, the results of this study could help to have better knowledge of the treatment effects from the different designed knee arthroplasties.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mobile bearing (MB) | – | Device: Knee arthroplasty |
| medial congruent (MC) | – | Device: Knee arthroplasty |
| posterior stabilized (PS) | – | Device: Knee arthroplasty |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Out patient department
Key inclusion criteria (1 listed)
- Diagnosed as knee joint osteoarthritis and will receive knee joint arthroplasty.
Key exclusion criteria (5 listed)
- Already receiving a knee joint arthroplasty surgery
- Can not walk independently for 20 m
- Can not stand for 5 min
- With neurological degenerative disease
- Lower limb received any surgery within recent 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Knee arthroplastyYour knee should be replaced with mobile bearing (MB), medial congruent (MC) and posterior stabilized (PS) design protheses. | Device | medial congruent (MC), mobile bearing (MB), posterior stabilized (PS) |
Primary outcome
Knee joint proprioception
Time frame: Pre-operation
Degrees
Knee joint proprioception
Time frame: Post-operation 6 weeks
Degrees
Knee joint proprioception
Time frame: Post-operation 3 months
Degrees
Postural stability index
Time frame: Pre-operation
Degrees
Postural stability index
Time frame: Post-operation 6 weeks
Degrees
Postural stability index
Time frame: Post-operation 3 months
Degrees
Angle of foot during walking
Time frame: Pre-operation
Degrees
Angle of foot during walking
Time frame: Post-operation 6 weeks
Degrees
Angle of foot during walking
Time frame: Post-operation 3 months
Degrees
Western Ontario and McMaster Universities Osteoarthritis Index, WOMAC
Time frame: Pre-operation
Scoring from 0 to 100, and higher scores mean a better outcome.
Western Ontario and McMaster Universities Osteoarthritis Index, WOMAC
Time frame: Post-operation 6 weeks
Scoring from 0 to 100, and higher scores mean a better outcome.
Western Ontario and McMaster Universities Osteoarthritis Index, WOMAC
Time frame: Post-operation 3 months
Scoring from 0 to 100, and higher scores mean a better outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Arthroplasty, Replacement, Knee and Proprioception, run by China Medical University Hospital at 1 site in Taiwan.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 28 Jan 2025. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee joint proprioception (time frame: Pre-operation). The study lists 12 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 28 Jan 2025.