Knee Replacement Systems for Osteoarthritis
Recruiting in Palo Alto (17 mi)
Overseen ByJames Nace, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: LifeBridge Health
No Placebo Group
Trial Summary
What is the purpose of this trial?Patients with degenerative joint disease can effectively be treated with a primary total knee replacement to reduce pain and improve function in their daily lives. Theoretically, achievement of normal knee motion using a medial pivot design in total knee replacements can be recreated in comparison to single radius designs, which could lead to an improvement in post-surgical outcomes and satisfaction with the procedure. The aim of this study is to compare two types of implant designs (medial pivot and single radius) in a total knee replacement using clinical outcomes, patient reported outcomes, and overall function assessed by a specialized gait laboratory.
What data supports the idea that Knee Replacement Systems for Osteoarthritis is an effective treatment?The available research shows that Knee Replacement Systems for Osteoarthritis, specifically the medial-pivot designs, are effective treatments. These systems are designed to mimic the natural movement of the knee, which can lead to better outcomes. Studies have shown that these systems provide increased stability and have a high success rate over the mid- to long-term. For example, one study reported a high success rate in a large group of over 1,100 cases. Additionally, patient satisfaction with these systems is generally high, with one study noting positive feedback from patients two months after surgery. While there are other designs like cruciate-retaining systems, the medial-pivot systems are gaining popularity due to their ability to replicate natural knee movement, which may improve overall outcomes.357810
Do I have to stop taking my current medications for the trial?The trial protocol does not specify whether you need to stop taking your current medications.
Is the MicroPort Evolution Medial-Pivot Knee System a promising treatment for knee replacement?Yes, the MicroPort Evolution Medial-Pivot Knee System is a promising treatment for knee replacement. It aims to mimic natural knee movement, which can lead to better knee function and stability. Studies show high patient satisfaction and good long-term outcomes, making it a popular choice for knee replacements.567810
What safety data exists for knee replacement systems in osteoarthritis treatment?The medial pivot knee design, introduced in the 1990s, aims to mimic natural knee motion and improve function. While mid-term outcomes are satisfactory, long-term results need further study. The design is compared with cruciate-retaining systems, which are more common in Norway and Australia. A study noted decreased survival of medial pivot designs compared to cruciate-retaining designs without patellar resurfacing. Another study reported a 98.7% survivorship rate at a minimum of 5 years for a third-generation cruciate-retaining system. Overall, while medial pivot designs show promise, more large-scale studies are needed to confirm their long-term safety and effectiveness.12479
Eligibility Criteria
This trial is for men and non-pregnant women aged 18-75 who need a knee replacement due to degenerative joint disease. They must be able to walk, attend follow-up visits, and not have had previous knee replacements or conditions that would affect walking tests.Inclusion Criteria
I am a man or a non-pregnant woman aged 18 to 75.
I am a man or a non-pregnant woman aged 18 to 75.
I am approved for a total knee replacement using specific knee implants.
Exclusion Criteria
I have been diagnosed with avascular necrosis or inflammatory arthritis.
Participant Groups
The study compares two types of knee implants: the MicroPort Evolution Medial-Pivot Knee System and the Stryker Triathlon Tritanium Knee System. It will assess which design better improves pain relief, function, and patient satisfaction after surgery.
2Treatment groups
Active Control
Group I: Single Radius Design Total Knee SystemActive Control1 Intervention
Total Knee Arthroplasty will be done by implanting the Stryker Triathlon Tritanium Knee System into subjects.
Group II: Medial-Pivot Knee SystemActive Control1 Intervention
Total Knee Arthroplasty will be done by implanting the MicroPort Medial Pivot Knee System into subjects.
MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting) is already approved in United States, European Union, Canada, Japan, Switzerland for the following indications:
🇺🇸 Approved in United States as MicroPort Evolution Medial-Pivot Knee System for:
- Degenerative joint disease
- Primary total knee replacement
🇪🇺 Approved in European Union as MicroPort Evolution Medial-Pivot Knee System for:
- Degenerative joint disease
- Primary total knee replacement
🇨🇦 Approved in Canada as MicroPort Evolution Medial-Pivot Knee System for:
- Degenerative joint disease
- Primary total knee replacement
🇯🇵 Approved in Japan as MicroPort Evolution Medial-Pivot Knee System for:
- Degenerative joint disease
- Primary total knee replacement
🇨🇭 Approved in Switzerland as MicroPort Evolution Medial-Pivot Knee System for:
- Degenerative joint disease
- Primary total knee replacement
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Sinai Hospital of BaltimoreBaltimore, MD
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Who is running the clinical trial?
LifeBridge HealthLead Sponsor
MicroPort Orthopedics Inc.Industry Sponsor
Rubin Institute for Advanced OrthopedicsCollaborator
References
Varus-valgus and rotational stability in rotationally unconstrained total knee arthroplasty. [2005]This study was designed to test the ability of the ligaments to restore rotational stability to the knee after rotationally unconstrained anterior cruciate-sacrificing total knee arthroplasty (TKA). Rotational and varus-valgus stability both were returned to near-normal values, and the normal screw home pattern of coupled external rotation with extension was restored when the ligaments were correctly tensioned. When the ligaments were tensioned so that the knee was either too loose or too tight, both varus-valgus and rotational laxity were affected equally. Rotational constraint is not necessary in a TKA system to achieve normal rotational stability of the knee, as long as normal varus-valgus stability is restored.
Cruciate-retaining TKA using a third-generation system with a four-pegged tibial component: a minimum 10-year followup note. [2021]A third-generation TKA system was designed to address problems encountered with earlier designs including a high rate of patellofemoral complications. At a minimum of 5 years, we previously reported survivorship of 98.7% using revision for any reason as the endpoint for a cohort that includes the patients described in this report. That cohort was unique in that a tibial component that uses four short pegs for fixation was used in a subset of patients undergoing cruciate-retaining TKA and the tibial and femoral components were precoated with polymethylmethacrylate.
Mid- to long-term outcomes of a medial-pivot system for primary total knee replacement: a systematic review and meta-analysis. [2022]This systematic review and meta-analysis was conducted to determine the mid- to long-term clinical outcomes for a medial-pivot total knee replacement (TKR) system. The objectives were to synthesise available survivorship, Knee Society Scores (KSS), and reasons for revision for this system.
Medial pivot knee in primary total knee arthroplasty. [2022]Total knee arthroplasty (TKA) with a medial pivot design was developed in order to mimic normal knee kinematics; the highly congruent medial compartment implant should improve clinical results and decrease contact stresses. Clinical and radiographic mid-term outcomes are satisfactory, but we need other studies to evaluate long-term results and indications for unusual cases.
Patient satisfaction at 2 months following total knee replacement using a second generation medial-pivot system: follow-up of 250 consecutive cases. [2020]Label="BACKGROUND" NlmCategory="BACKGROUND">Patient dissatisfaction following total knee replacement (TKR) has been reported as high as 24%. Most previous studies have focused on satisfaction for TKR overall, with few reporting satisfaction for specific implant designs. The purpose of this study was to assess patient satisfaction for TKRs performed using a second generation medial-pivot system (EVOLUTION®, MicroPort Orthopedics Inc., Arlington, TN, USA).
Total knee arthroplasty with the Medial-Pivot knee system: Clinical and radiological outcomes at 9.5 years' mean follow-up. [2019]The "ball-in-socket" design of the Medial-Pivot knee system (MicroPort Orthopedics, Arlington, Tennessee, USA) aims to reproduce normal knee kinematics by medializing its rotational axis. The goal of this study was to measure knee range of motion (ROM) with this implant after a mean follow-up of 10 years and to report the survivorship and long-term clinical and radiological outcomes. We hypothesized the prosthetic knee would have at least 120° flexion at 10 years.
Decreased Survival of Medial Pivot Designs Compared with Cruciate-retaining Designs in TKA Without Patellar Resurfacing. [2022]The medial pivot TKA design was introduced in the 1990s. These are fixed-bearing, medial-conforming implants with virtually no translation in the medial part of the knee, in contrast to the flat lateral part of the insert allowing for translation similar to the native knee during flexion and extension. Most primary TKAs performed in Norway and Australia are cruciate-retaining. All of the medial pivot implants in our study are cruciate-sacrificing but without a post-cam mechanism. The medial pivot implant design was developed to more closely mimic native knee motion, in the hope of improving function, and not primarily as a more constrained knee for difficult cases. In the past 10 to 12 years, a second-generation medial-pivot design has emerged, but there are no larger registry studies on the survival of these implants. Both cruciate-retaining and medial pivot designs are reported in the Australian and Norwegian registries, allowing for large-scale, comparative survivorship studies.
Mid-term clinical outcomes and survivorship of medial-pivot total knee arthroplasty-a mean five year follow-up based on one thousand, one hundred and twenty eight cases. [2022]The unique medial-pivot (MP) design of ADVANCE® system largely simulates the movement of a normal knee joint and a high mid- and long-term success rate has been reported in limited populations. The aims of this study are to investigate the mid-term clinical outcomes and survivorship based on a large cohort with 1128 cases.
How does asymmetric tibial insert affect tibiofemoral kinematics and contact stresses in total knee Arthroplasty? [2022]Asymmetric tibial insert design is expected to restore normal knee kinematics better than symmetric design. A tri-condylar implant has asymmetric and symmetric tibial inserts with a ball-and-socket joint to replace the post-cam mechanism. The purpose of this study was to compare the knee kinematics of the two designs and to measure tibiofemoral contact stresses, including that of the ball-and-socket joint.
Medial Pivot Designs Versus Conventional Bearing Types in Primary Total Knee Arthroplasty: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2023]Medial pivot (MP) designs are growing in popularity. They provide increased sagittal plane stability and theoretically replicate some aspects of native joint kinematics, which may improve total knee arthroplasty outcomes.