Knee ArthropathyNCT04183985
Comparison of Radiological, Clinical, Functional Outcomes Between Anatomically Aligned Total Knee Arthroplasty and Conventional Total Knee Arthroplasty
A study testing Total knee arthroplasty prosthesis in people with Knee Arthropathy and Anatomically Aligned Total Knee Arthroplasty, run by The Catholic University of Korea.
Trial summary
Total knee arthroplasty(TKA) is a successful orthopedic surgery with excellent clinical outcome and survival. However, there are concerns about patient satisfaction in previous reports, and dissatisfaction rate of 15-30% is reported in clinical outcomes(PROMs) of some studies. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Knee Arthropathy, Anatomically Aligned Total Knee Arthroplasty
- What is being tested?
- Total knee arthroplasty prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients for bilateral total knee arthroplasty
- having medicare insurance
Who cannot join
- Rheumatoid arthritis
- Other inflammatory arthritis
- Crystal-induced arthritis
- Septic arthritis
- Neuropsychiatric patients
- Previous knee operation history
Show all 10Show fewer
- Neuropsychiatric patients
- Patients with preoperative severe limitation of motion (Flexion contracture ≥ 20, range of motion ≤ 90)
- Patients with preoperative severe defomity of knee alignment (Varus or valgus angle ≥ 15)
- Severe obese patients (BMI ≥ 40)
Trial locations and contacts
No sites are listed yet.
About this study
Total knee arthroplasty(TKA) is a successful orthopedic surgery with excellent clinical outcome and survival. However, there are concerns about patient satisfaction in previous reports, and dissatisfaction rate of 15-30% is reported in clinical outcomes(PROMs) of some studies. Therefore, for improving the patient's outcome and satisfaction after total knee arthroplasty, it is necessary to change the design of the conventional total knee arthroplsaty implant. The knee is a joint structure with several dynamic functions, and not only the skeletal structure but also the soft tissue balance plays an important role in the function of the knee joint. New implants are being developed to overcome the limitations of conventional TKA implant, including the Journey II Bi-cruciate substituting total knee system (JII-BCS; Smith \& Nephew). JII-BCS implant has normal articular geometry, more anatomical femoral shape, lateral tibial convex geometry, and asymmetrical tibial plateau, anterior and posterior cams, which has been shown in experimental studies to produce nearly normal knee movement by reproducing the actual normal anatomical alignment in vivo.
The clinical results of the kinematic effects of this anatomcally aligned change are insufficient, and there is also a lack of comparative studies with conventional total knee arthroplasty implant. The purpose of this study is to compare outcomes between anatomically aligned TKA(JII-BCS) and conventional TKA(Legion total knee system, Smith \& Nephew). This study is a randomized controlled study in patients undergoing same-day bilateral total knee arthroplasty. A patient undergoing same-day bilateral total knee arthroplasty will use a random number to determine the instruments(JII-BCS or Legion), and both knee joints will be operated with the same instruments. Radiologic parameter, patients preference and clinical results was investigated in patients who received TKA during minimum 2 year follow up.
- Being tested
- Total knee arthroplasty prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplasty prosthesisDevice
In patients undergoing same-day bilateral total knee arthroplasty, after deciding the implant of TKA(anatomically aligned TKA implant or conventaional TKA implant) using random number table, compare the result of clinical outcome about two instruments.
| Study group | Role | What they receive |
|---|---|---|
| Anatomically aligned total knee arthroplasty | Experimental | Use anatomically aligned total knee arthroplasty implant (Journey II Bi-cruciate substituting total knee system, JII-BCS, Smith \& Nephew) in patients undergoing same-day bilateral total knee arthroplasty. Receives: Device: Total knee arthroplasty prosthesis |
| Conventaional total knee arthroplasty | Active comparator | Use conventional total knee arthroplasty implant (Legion total knee system, Smith \& Nephew) in patients undergoing same-day bilateral total knee arthroplasty. Receives: Device: Total knee arthroplasty prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Western Ontario and McMaster Universities Index(WOMAC index)
Measured: Change from baseline score to score of postoperative1 year
Secondary outcomes (2)
Change in Knee Society Score
Measured: Change from baseline score to score of postoperative1 year
Change in Range of Motion
Measured: Change from baseline Range of Motion at postoperative1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start1 Dec 2019 (estimated)
- Primary completion31 Dec 2020 (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 Knee ArthropathyStudies 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 (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183985
- Sponsor's protocol ID
- Anatomically aligned TKRA2
- Status last verified
- Dec 2019
- First submitted
- 31 Oct 2019
- Last updated
- 3 Dec 2019
- 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 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Radiological, Clinical, Functional Outcomes Between Anatomically Aligned Total Knee Arthroplasty and Conventional Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04183985
- Acronym / sponsor ID
- Anatomically aligned TKRA2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 3 Dec 2019 (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 a successful orthopedic surgery with excellent clinical outcome and survival. However, there are concerns about patient satisfaction in previous reports, and dissatisfaction rate of 15-30% is reported in clinical outcomes(PROMs) of some studies. Therefore, for improving the patient's outcome and satisfaction after total knee arthroplasty, it is necessary to change the design of the conventional total knee arthroplsaty implant. The knee is a joint structure with several dynamic functions, and not only the skeletal structure but also the soft tissue balance plays an important role in the function of the knee joint. New implants are being developed to overcome the limitations of conventional TKA implant, including the Journey II Bi-cruciate substituting total knee system (JII-BCS; Smith \& Nephew). JII-BCS implant has normal articular geometry, more anatomical femoral shape, lateral tibial convex geometry, and asymmetrical tibial plateau, anterior and posterior cams, which has been shown in experimental studies to produce nearly normal knee movement by reproducing the actual normal anatomical alignment in vivo.
The clinical results of the kinematic effects of this anatomcally aligned change are insufficient, and there is also a lack of comparative studies with conventional total knee arthroplasty implant. The purpose of this study is to compare outcomes between anatomically aligned TKA(JII-BCS) and conventional TKA(Legion total knee system, Smith \& Nephew). This study is a randomized controlled study in patients undergoing same-day bilateral total knee arthroplasty. A patient undergoing same-day bilateral total knee arthroplasty will use a random number to determine the instruments(JII-BCS or Legion), and both knee joints will be operated with the same instruments. Radiologic parameter, patients preference and clinical results was investigated in patients who received TKA during minimum 2 year follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anatomically aligned total knee arthroplasty | Experimental | Device: Total knee arthroplasty prosthesisUse anatomically aligned total knee arthroplasty implant (Journey II Bi-cruciate substituting total knee system, JII-BCS, Smith \& Nephew) in patients undergoing same-day bilateral total knee arthroplasty. |
| Conventaional total knee arthroplasty | Active comparator | Device: Total knee arthroplasty prosthesisUse conventional total knee arthroplasty implant (Legion total knee system, Smith \& Nephew) in patients undergoing same-day bilateral total knee arthroplasty. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients for bilateral total knee arthroplasty
- having medicare insurance
Key exclusion criteria (10 listed)
- Rheumatoid arthritis
- Other inflammatory arthritis
- Crystal-induced arthritis
- Septic arthritis
- Neuropsychiatric patients
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 |
|---|---|---|
| Total knee arthroplasty prosthesisIn patients undergoing same-day bilateral total knee arthroplasty, after deciding the implant of TKA(anatomically aligned TKA implant or conventaional TKA implant) using random number table, compare the result of clinical outcome about two instruments. | Device | Anatomically aligned total knee arthroplasty, Conventaional total knee arthroplasty |
Primary outcome
Change in Western Ontario and McMaster Universities Index(WOMAC index)
Time frame: Change from baseline score to score of postoperative1 year
2 secondary outcomes
Change in Knee Society Score
Time frame: Change from baseline score to score of postoperative1 year
Change in Range of Motion
Time frame: Change from baseline Range of Motion at postoperative1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee arthroplasty prosthesis in people with Knee Arthropathy and Anatomically Aligned Total Knee Arthroplasty, run by The Catholic University of 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 2 inclusion and 10 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 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Yong In, MD, PhD (821090445228, iy1000@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Western Ontario and McMaster Universities Index(WOMAC index) (time frame: Change from baseline score to score of postoperative1 year). 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 3 Dec 2019.