Osteoarthritis, KneeNCT04684160
Comparison of Joint Awareness Between Fixed-bearing and Mobile-bearing Total Knee Arthroplasty Using Titanium-nitride Coated Posterior-stabilized Prostheses
A study testing Fixed-bearing TKA and Mobile-bearing TKA in people with Osteoarthritis, Knee and Arthropathy of Knee, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
Comparison of postoperative patient's joint awareness as well as clinical and radiological outcomes between fixed- and mobile-bearing total knee arthroplasty of which the prosthesis is coated with Titanium-nitride. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Arthropathy of Knee, Joint Awareness
- What is being tested?
- Fixed-bearing TKA and Mobile-bearing TKA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Oct 2016to 31 Dec 2022
- Phase
- Interventional
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with knee joint advanced osteoarthritis
- Age over 55 years old
- Scheduled to undergo primary total knee arthroplasty
Who cannot join
- Post-traumatic or inflammatory osteoarthritis
- Those who undertook previous ligamentous surgery
- Those who do not understand and give answers to a survey
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea Seoul St Mary's hospital
Seoul
About this study
Comparison of postoperative patient's joint awareness as well as clinical and radiological outcomes between fixed- and mobile-bearing total knee arthroplasty of which the prosthesis is coated with Titanium-nitride.
Read the detailed description
Despite numerous comparison studies between mobile- and fixed-bearing TKA as well as several comparison studies regarding clinical and radiological outcomes using titanium-nitride(TiN) prosthesis, there has been no study on postoperative joint awareness despite mobile- and fixed-bearing TKA using TiN prosthesis.
- Conditions
- Osteoarthritis, Knee, Arthropathy of Knee, Joint Awareness
- Being tested
- Fixed-bearing TKA, Mobile-bearing TKA
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed-bearing TKADevice
Mobile-bearing TKADevice
| Study group | Role | What they receive |
|---|---|---|
| Fixed-bearing group | Active comparator | Not described Receives: Device: Fixed-bearing TKA |
| Mobile-bearing group | Experimental | Not described Receives: Device: Mobile-bearing TKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forgotten joint score
Questionnaire of evaluating how much the patients are aware of their operate joint during daily activities. The higher, the worse. Range: 0-100
Measured: Postoperative 3 years
Crepitus
Any grating, crackling or popping sensation around knee when moving a joint
Measured: Postoperative 3 years
Secondary outcomes (2)
Forgotten joint score
Questionnaire of evaluating how much the patients are aware of their operate joint during daily activities. The higher, the worse. Range: 0-100
Measured: Postoperative 5 years
Crepitus
Any grating, crackling or popping sensation around knee when moving a joint
Measured: Postoperative 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start19 Oct 2016
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong In, The Catholic University of Korea
- Investigators
- Yong In, M.D., Ph.D., Study chair, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684160
- Sponsor's protocol ID
- CUKorea MB
- Status last verified
- Dec 2020
- First submitted
- 16 Dec 2020
- Last updated
- 24 Dec 2020
- 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 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Joint Awareness Between Fixed-bearing and Mobile-bearing Total Knee Arthroplasty Using Titanium-nitride Coated Posterior-stabilized Prostheses
- ClinicalTrials.gov ID
- NCT04684160
- Acronym / sponsor ID
- CUKorea MB
- Conditions
- Osteoarthritis, Knee, Arthropathy of Knee, Joint Awareness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 19 Oct 2016 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 24 Dec 2020 (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.
Comparison of postoperative patient's joint awareness as well as clinical and radiological outcomes between fixed- and mobile-bearing total knee arthroplasty of which the prosthesis is coated with Titanium-nitride.
Detailed description
Despite numerous comparison studies between mobile- and fixed-bearing TKA as well as several comparison studies regarding clinical and radiological outcomes using titanium-nitride(TiN) prosthesis, there has been no study on postoperative joint awareness despite mobile- and fixed-bearing TKA using TiN prosthesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed-bearing group | Active comparator | Device: Fixed-bearing TKA |
| Mobile-bearing group | Experimental | Device: Mobile-bearing TKA |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with knee joint advanced osteoarthritis
- Age over 55 years old
- Scheduled to undergo primary total knee arthroplasty
Key exclusion criteria (3 listed)
- Post-traumatic or inflammatory osteoarthritis
- Those who undertook previous ligamentous surgery
- Those who do not understand and give answers to a survey
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 |
|---|---|---|
| Fixed-bearing TKA | Device | Fixed-bearing group |
| Mobile-bearing TKA | Device | Mobile-bearing group |
Primary outcome
Forgotten joint score
Time frame: Postoperative 3 years
Questionnaire of evaluating how much the patients are aware of their operate joint during daily activities. The higher, the worse. Range: 0-100
Crepitus
Time frame: Postoperative 3 years
Any grating, crackling or popping sensation around knee when moving a joint
2 secondary outcomes
Forgotten joint score
Time frame: Postoperative 5 years
Crepitus
Time frame: Postoperative 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
- 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.
Yong In, M.D., Ph.D. study chair
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixed-bearing TKA and Mobile-bearing TKA in people with Osteoarthritis, Knee and Arthropathy of Knee, run by The Catholic University of Korea at 1 site in South Korea.
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 3 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 24 Dec 2020. 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 South Korea. 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?
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?
Forgotten joint score (time frame: Postoperative 3 years). The study lists 2 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 24 Dec 2020.