Osteoarthritis, KneeNCT06124651
Comparison of Cruciate Retaining and Posterior Stabilized Total Knee Arthroplasty
A study testing Total knee replacement with cruciate retaining femoral component and Total knee replacement with cruciate substituting femoral component in people with Osteoarthritis, Knee and Arthropathy of Knee Joint, run by Ewha Womans University.
Trial summary
Several authors and large registries have suggested the potential for an increased risk of all-cause revision with the use of posterior cruciate-substitution (PS) total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 25 to 99 years
- Conditions the study is for
- Osteoarthritis, Knee, Arthropathy of Knee Joint
- What is being tested?
- Total knee replacement with cruciate retaining femoral component and Total knee replacement with cruciate substituting femoral component
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2004to 16 May 2023
- 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 25 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease
Who cannot join
- Inflammatory disease
- patient with other Lower extremity disease which may affect functional outcome
- Neurologic disease effecting patients lower extremity
- Revision surgery
- Patient not medically cleared for bilateral surgery
About this study
Official title: Clinical Comparison of Cruciate Retaining and Posterior Stabilized Total Knee Arthroplasty in Same Patients
Several authors and large registries have suggested the potential for an increased risk of all-cause revision with the use of posterior cruciate-substitution (PS) total knee arthroplasty (TKA). The purpose of the current study was to compare posterior cruciate retaining (CR) and PS implants with respect to the functional and radiographic results, prevalence of osteolysis, revision rates and survivorship.
Read the detailed description
The supremacy debate between posterior cruciate-retaining (CR) and posterior stabilized (PS) total knee arthroplasty (TKA) has now entered into the 4th decade. Multiple research studies have investigated CR and PS TKAs on the basis of kinematic, clinical, radiographic, and survivorship analysis. Despite arguments in favor of CR or PS TKA designs, several short or mid-term studies have shown no difference in functional outcomes between these two designs. Considering the fact that CR and PS TKA fare equally at short-term and mid-term, the decision to select either design should depend on their long-term survivorship. There have been few long-term survivorship analysis that have directly compared CR and PS TKAs with aseptic revision for any reason as the end point.
These long-term studies of CR and PS TKA have been done independently. A comparison of the results in the same patients eliminates the variability that is introduced by differences in gender, age, weight, comorbidity, bone quality, and activity level and allows for a meaningful comparison of the impact of fixation on the outcome of TKA. However, variability in terms of the preoperative severity of arthritis cannot be eliminated because of the design on both sides is rarely identical.
The purpose of this study was to identify differences in implant survivorship between CR and PS TKAs in patients with osteoarthritis who were younger than 65 years of age and CR implant in one knee and PS implant in the other.
- Conditions
- Osteoarthritis, Knee, Arthropathy of Knee Joint
- Being tested
- Total knee replacement with cruciate retaining femoral component, Total knee replacement with cruciate substituting femoral component
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee replacement with cruciate retaining femoral componentProcedure or surgery
To perform the total knee replacement, the knee joint is anatomically dissected, and thin portions of bone and cartilage is resected to accommodate a metallic implants. Implants are fixed to patients' bone with bone cements. Many designs for femoral component designs are available. In the present study, two types of implants, one CR(cruciate retaining), where the posterior cruciate ligaments are retained, and one PS(Posterior cruciate substituting), where the posterior cruciate ligaments are resected, will be compared. To make the comparison more reliable, the same kind of implants will be used, so that the major portions of femoral component design remains the same and the tibial component remains the same. Only the cruciate ligament parts are different. For this arm of intervention, CR knee will be used, so posterior cruciate will remain intact after the surgery and still function to aid in the knee stability.
Total knee replacement with cruciate substituting femoral componentProcedure or surgery
To perform the total knee replacement, the knee joint is anatomically dissected, and thin portions of bone and cartilage is resected to accommodate metallic implants that has similar contours of a native knee. Implants are fixed to patients' bone with bone cements. This procedure will use the femoral component that sacrifice the posterior cruciate ligament and having a box area with a post, so that "cam-post" mechanism of implants can mimic the function of the posterior cruciate ligament. To make the comparison more reliable, the same kind of implants will be used, so that the major portions of femoral component remains the same. The tibial component will remain the same design. Therefore, only the cruciate ligament parts will be different.
| Study group | Role | What they receive |
|---|---|---|
| CR knee | Active comparator | This type of total knee arthroplasty retains the posterior cruciate ligament. Receives: Procedure: Total knee replacement with cruciate retaining femoral component |
| PS knee | Active comparator | This type of total knee sacrifices the posterior cruciate ligament and cam and post mechanism replaces its function. Receives: Procedure: Total knee replacement with cruciate substituting femoral component |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Knee Society Knee Score
change in knee score will be compared with initial score, until mean follow up of 25 years. The score ranges from 0 to 100, and the 100 is the highest.
Measured: Initial(one day before surgery), at 3 months after the surgery, 1 year after the surgery, and then average 1 year after until the study completion
Secondary outcomes (1)
Improvement in the Range of motion
change in the range of motion of knee joint will be compared with the initial value, until mean follow up of 25 years.The range of motion for knee typically are around 0 degrees to 130 degrees, and more range is considered as a better outcome.
Measured: Initial(one day before surgery), and at 3 months after the surgery, 1 year after the surgery, and then average 1year after surgery until the study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start1 Jan 2004
- Primary completion30 Jun 2006
- Study completion16 May 2023
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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Hoo Kim, Ewha Womans University
- Investigators
- Young Hoo Kim, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124651
- Sponsor's protocol ID
- tka_cr_ps
- Status last verified
- Nov 2023
- First submitted
- 23 Aug 2023
- Last updated
- 9 Nov 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 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Cruciate Retaining and Posterior Stabilized Total Knee Arthroplasty in Same Patients
- ClinicalTrials.gov ID
- NCT06124651
- Acronym / sponsor ID
- tka_cr_ps
- Conditions
- Osteoarthritis, Knee, Arthropathy of Knee Joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Ewha Womans UniversityUniversity, hospital or other
- Study start
- 1 Jan 2004 (actual)
- Primary completion
- 30 Jun 2006 (actual)
- Study completion
- 16 May 2023 (actual)
- First posted
- 9 Nov 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.
Several authors and large registries have suggested the potential for an increased risk of all-cause revision with the use of posterior cruciate-substitution (PS) total knee arthroplasty (TKA). The purpose of the current study was to compare posterior cruciate retaining (CR) and PS implants with respect to the functional and radiographic results, prevalence of osteolysis, revision rates and survivorship.
Detailed description
The supremacy debate between posterior cruciate-retaining (CR) and posterior stabilized (PS) total knee arthroplasty (TKA) has now entered into the 4th decade. Multiple research studies have investigated CR and PS TKAs on the basis of kinematic, clinical, radiographic, and survivorship analysis. Despite arguments in favor of CR or PS TKA designs, several short or mid-term studies have shown no difference in functional outcomes between these two designs. Considering the fact that CR and PS TKA fare equally at short-term and mid-term, the decision to select either design should depend on their long-term survivorship. There have been few long-term survivorship analysis that have directly compared CR and PS TKAs with aseptic revision for any reason as the end point.
These long-term studies of CR and PS TKA have been done independently. A comparison of the results in the same patients eliminates the variability that is introduced by differences in gender, age, weight, comorbidity, bone quality, and activity level and allows for a meaningful comparison of the impact of fixation on the outcome of TKA. However, variability in terms of the preoperative severity of arthritis cannot be eliminated because of the design on both sides is rarely identical.
The purpose of this study was to identify differences in implant survivorship between CR and PS TKAs in patients with osteoarthritis who were younger than 65 years of age and CR implant in one knee and PS implant in the other.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CR knee | Active comparator | Procedure: Total knee replacement with cruciate retaining femoral componentThis type of total knee arthroplasty retains the posterior cruciate ligament. |
| PS knee | Active comparator | Procedure: Total knee replacement with cruciate substituting femoral componentThis type of total knee sacrifices the posterior cruciate ligament and cam and post mechanism replaces its function. |
Who may qualify
- Ages
- 25 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease
Key exclusion criteria (5 listed)
- Inflammatory disease
- patient with other Lower extremity disease which may affect functional outcome
- Neurologic disease effecting patients lower extremity
- Revision surgery
- Patient not medically cleared for bilateral surgery
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 replacement with cruciate retaining femoral componentTo perform the total knee replacement, the knee joint is anatomically dissected, and thin portions of bone and cartilage is resected to accommodate a metallic implants. Implants are fixed to patients' bone with bone cements. Many designs for femoral component designs are available. In the present study, two types of implants, one CR(cruciate retaining), where the posterior cruciate ligaments are retained, and one PS(Posterior cruciate substituting), where the posterior cruciate ligaments are resected, will be compared. To make the comparison more reliable, the same kind of implants will be used, so that the major portions of femoral component design remains the same and the tibial component remains the same. Only the cruciate ligament parts are different. For this arm of intervention, CR knee will be used, so posterior cruciate will remain intact after the surgery and still function to aid in the knee stability. | Procedure or surgery | CR knee |
| Total knee replacement with cruciate substituting femoral componentTo perform the total knee replacement, the knee joint is anatomically dissected, and thin portions of bone and cartilage is resected to accommodate metallic implants that has similar contours of a native knee. Implants are fixed to patients' bone with bone cements. This procedure will use the femoral component that sacrifice the posterior cruciate ligament and having a box area with a post, so that "cam-post" mechanism of implants can mimic the function of the posterior cruciate ligament. To make the comparison more reliable, the same kind of implants will be used, so that the major portions of femoral component remains the same. The tibial component will remain the same design. Therefore, only the cruciate ligament parts will be different. | Procedure or surgery | PS knee |
Primary outcome
Improvement in Knee Society Knee Score
Time frame: Initial(one day before surgery), at 3 months after the surgery, 1 year after the surgery, and then average 1 year after until the study completion
change in knee score will be compared with initial score, until mean follow up of 25 years. The score ranges from 0 to 100, and the 100 is the highest.
1 secondary outcome
Improvement in the Range of motion
Time frame: Initial(one day before surgery), and at 3 months after the surgery, 1 year after the surgery, and then average 1year after surgery until the study completion.
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 9 Nov 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.
Young Hoo Kim, MD principal investigator
Professor
Questions about this trial
What is this clinical trial studying?
A study testing Total knee replacement with cruciate retaining femoral component and Total knee replacement with cruciate substituting femoral component in people with Osteoarthritis, Knee and Arthropathy of Knee Joint, run by Ewha Womans University.
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 9 Nov 2023. 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?
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?
Improvement in Knee Society Knee Score (time frame: Initial(one day before surgery), at 3 months after the surgery, 1 year after the surgery, and then average 1 year after until the study completion). 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 9 Nov 2023.