Knee Replacement Systems for Osteoarthritis

Overseen By Ronald Delanois, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: LifeBridge Health

Disqualifiers: Bmi >40, Avascular necrosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve knee replacements for individuals with osteoarthritis, a condition causing joint pain and stiffness. It compares two types of knee implants to determine which provides better pain relief and movement post-surgery. The study tests a medial pivot design (MicroPort Evolution Medial-Pivot Knee System) against a single radius design (Stryker Triathlon Tritanium Knee System) for knee replacements. Suitable candidates for this trial are those needing a knee replacement who have not had one on the same knee before, can walk, and do not have conditions affecting the other leg. As an unphased trial, it offers participants the chance to contribute to advancements in knee replacement technology, potentially improving outcomes for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.

What prior data suggests that these knee replacement systems are safe for osteoarthritis patients?

Research shows that both the MicroPort Evolution Medial-Pivot Knee System and the Stryker Triathlon Tritanium Knee System are safe options. Studies indicate a 95% patient satisfaction rate and a 98.8% success rate over time for the MicroPort Medial-Pivot Knee System, meaning most patients are happy with the implant, and it lasts well in the body.

The Stryker Triathlon Tritanium Knee System also demonstrates positive results, having been used in over 3 million cases. Studies show a 98.7% success rate, which increases to 99.2% when excluding infections, suggesting the implant is reliable and well-accepted by patients.

Both knee systems have been successfully used in many patients and consistently show good safety and satisfaction results. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for osteoarthritis because they introduce innovative knee replacement systems. The MicroPort Evolution Medial-Pivot Knee System is unique as it mimics the natural movement of the knee joint more closely than traditional designs, potentially leading to improved stability and a more natural feel for patients. On the other hand, the Stryker Triathlon Tritanium Knee System stands out with its advanced condylar stabilizing feature, which aims to enhance joint stability and longevity by using a specialized material called Tritanium. Both systems focus on improving patient outcomes by enhancing joint function and comfort, offering promising alternatives to conventional knee replacement options.

What evidence suggests that this trial's knee replacement systems could be effective for osteoarthritis?

Research has shown that both the MicroPort Evolution Medial-Pivot Knee System and the Stryker Triathlon Tritanium Knee System effectively replace knees in people with osteoarthritis. In this trial, participants will receive one of these systems. The MicroPort system, which participants may receive, has a 95% patient satisfaction rate and a 98.8% survival rate, indicating that most knee replacements last long without needing another surgery. Studies also suggest it provides better stability and outcomes compared to some other designs. Meanwhile, the Stryker system, another option in this trial, has a 98.7% survival rate, meaning few patients require another surgery due to issues. It also boasts high satisfaction rates, with 79%-94% of patients satisfied with their results over ten years. Both systems aim to improve movement and reduce pain, making daily activities easier. ^{1 2 4 5 6}

Who Is on the Research Team?

James Nace, MD

Principal Investigator

LifeBridge Health

Are You a Good Fit for This Trial?

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

You have a prosthetic device on the operative knee.

I can walk and have no issues with my other limb that would affect walking tests.

Subject is willing to provide informed consent to participate in the research study

Exclusion Criteria

You have a mental or neuromuscular condition that could make it risky for you to have surgery or could cause problems with the artificial body part after the surgery.

Subject has a Body Mass Index (BMI) >40

Subject is a prisoner

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Pre-operative assessments and baseline measurements are conducted

1-2 weeks

1 visit (in-person)

Operative

Total Knee Arthroplasty is performed using either the Medial Pivot or Single Radius design

1 day

1 visit (in-person)

Post-operative Follow-up

Participants are monitored for post-surgical outcomes and complications

60 months

6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting)
• Stryker Triathlon Tritanium Knee System (Condylar Stabilizing)

Trial Overview 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.

How Is the Trial Designed?

Group I: Single Radius Design Total Knee System Active Control 1 Intervention

Total Knee Arthroplasty will be done by implanting the Stryker Triathlon Tritanium Knee System into subjects.

Group II: Medial-Pivot Knee System Active Control 1 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

Who Is Running the Clinical Trial?

LifeBridge Health

Lead Sponsor

Trials

32

Recruited

4,500+

MicroPort Orthopedics Inc.

Industry Sponsor

Trials

33

Recruited

3,700+

Rubin Institute for Advanced Orthopedics

Collaborator

Trials

2

Recruited

180+

Published Research Related to This Trial

In a study of 74 Medial-Pivot knee implants followed for an average of 10 years, the average knee range of motion achieved was 110°, which was lower than the hypothesized 120° flexion.

The survivorship rate of the Medial-Pivot knee was 93% overall, indicating good long-term durability, with no cases of aseptic loosening observed, suggesting satisfactory clinical and radiological outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total knee arthroplasty with the Medial-Pivot knee system: Clinical and radiological outcomes at 9.5 years' mean follow-up. Dehl, M., Bulaïd, Y., Chelli, M., et al.[2019]

In a study of 224 patients who underwent total knee replacement (TKR) using a second generation medial-pivot system, 94.6% reported being very satisfied or satisfied at the 2-month follow-up, indicating high patient satisfaction with this specific implant design.

Satisfaction rates improved to 99.4% after the first 50 surgeries, suggesting that surgeon experience with the system may enhance outcomes, and overall functional scores and range of motion were also satisfactory.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient satisfaction at 2 months following total knee replacement using a second generation medial-pivot system: follow-up of 250 consecutive cases. Van Overschelde, PP., Fitch, DA.[2020]

In a study of 1128 total knee arthroplasties (TKAs) using the ADVANCE® medial-pivot design, excellent mid-term clinical outcomes were observed, with high scores in range of motion and patient-reported outcomes after an average follow-up of five years.

The overall survivorship of the ADVANCE® MP TKAs was 99.2% at seven years, indicating a strong long-term success rate, although when accounting for lost follow-ups as failures, the survivorship dropped to 50.6% at seven years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Xiang, S., Wang, Y., Lv, C., et al.[2022]

The study found that the asymmetric tibial insert design allows for better knee kinematics, showing a more posterior position and greater external rotation of the femoral component compared to the symmetric design during movement.

Despite these kinematic advantages, both designs resulted in low peak contact stresses (less than 9 MPa), indicating that the asymmetric design does not negatively impact joint stress and may offer clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How does asymmetric tibial insert affect tibiofemoral kinematics and contact stresses in total knee Arthroplasty? Song, YD., Nakamura, S., Kuriyama, S., et al.[2022]

In a study of 161 patients who underwent 179 total knee arthroplasties (TKAs), the survival rate of the third-generation TKA system was 97.7% at a minimum of 10 years, with no revisions needed for patellar component issues, indicating high efficacy and safety of the design.

The study showed significant improvement in patient function, with Hospital for Special Surgery scores increasing from an average of 47.7 preoperatively to 85.4 postoperatively, demonstrating effective functional outcomes after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cruciate-retaining TKA using a third-generation system with a four-pegged tibial component: a minimum 10-year followup note. Schwartz, AJ., Della Valle, CJ., Rosenberg, AG., et al.[2021]

The medial pivot TKA design showed a higher risk of revision compared to cruciate-retaining designs in Australia, with a hazard ratio of 1.4, indicating potential concerns about its long-term effectiveness.

Specific brands of the medial pivot design, such as the Advance II MP and GMK Sphere, had significantly higher revision rates, suggesting that not all medial pivot implants perform equally well in terms of survivorship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreased Survival of Medial Pivot Designs Compared with Cruciate-retaining Designs in TKA Without Patellar Resurfacing. Øhrn, FD., Gøthesen, Ø., Låstad Lygre, SH., et al.[2022]

A systematic review of 8 randomized controlled trials involving 725 knees found no significant differences in clinical outcomes between medial pivot (MP) designs and posterior-stabilized (PS) designs in total knee arthroplasty, suggesting that both designs perform similarly.

The analysis indicated that while some measures favored PS or MP at different time points, none reached statistical significance, highlighting the need for more research to compare MP with other bearing types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medial Pivot Designs Versus Conventional Bearing Types in Primary Total Knee Arthroplasty: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Hoskins, W., Smith, G., Spelman, T., et al.[2023]

The medial-pivot total knee replacement (TKR) system demonstrated excellent survivorship rates of 99.2% at five years and 97.6% at eight years, which are comparable or superior to other cemented TKR systems.

Post-operative Knee Society Scores (KSS) averaged 87.9, indicating a high level of patient satisfaction and function, similar across various international centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mid- to long-term outcomes of a medial-pivot system for primary total knee replacement: a systematic review and meta-analysis. Fitch, DA., Sedacki, K., Yang, Y.[2022]

The medial pivot design in total knee arthroplasty (TKA) aims to replicate natural knee movement, potentially leading to better clinical outcomes and reduced stress on the knee joint.

Current mid-term clinical and radiographic results are promising, but further research is necessary to assess the long-term effectiveness and suitability of this design for atypical cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medial pivot knee in primary total knee arthroplasty. Atzori, F., Salama, W., Sabatini, L., et al.[2022]

The study demonstrated that after anterior cruciate-sacrificing total knee arthroplasty (TKA), restoring proper tension in the ligaments can bring both rotational and varus-valgus stability of the knee back to near-normal levels.

It was found that achieving normal rotational stability does not require additional rotational constraints in the TKA system, as long as varus-valgus stability is effectively restored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Varus-valgus and rotational stability in rotationally unconstrained total knee arthroplasty. Whiteside, LA., Kasselt, MR., Haynes, DW.[2005]

Citations

1. microportortho.com microportortho.com/products/knees/primary-total-knee-systems/evolution-knee-systems

Evolution® Medial-Pivot Knee Systems Improved stability and validated outcomes. The Evolution® medial-pivot knee system is built upon a legacy of 95% patient satisfaction with 98.8% survivorship at ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40493985/

Long-term outcomes, satisfaction, and survival rates of a ... The aim of this study was to evaluate the long-term clinical outcomes, satisfaction, perceived joint stability, and survival rates following medial pivot TKA.

3. microport.com microport.com/healthcare-professional/orthopedics/knees

The original medial-pivot knee design - Orthopedics The unique design and successful clinical heritage of MicroPort® Orthopedics' medial-pivot knees sets the EvolutionTM Knee System apart from the competition.

4. microport.com microport.com/news/microport-orthopedics-receives-15a-odep-rating-for-its-advance-medial-pivot-knee-system

Orthopedics Gets High Rating for Knee System | News MicroPort Orthopedics received a '15A' rating from the Orthopedic Data Evaluation Panel (ODEP) for its independently-developed Advance Medial-Pivot Knee System.

5. microportortho.com microportortho.com/knee-clinical-studies

Knee Clinical Studies Kato, M., et al. Medial pivot-based total knee arthroplasty achieves better clinical outcomes than posterior-stabilised total knee arthroplasty.

6. osimplantes.com.br osimplantes.com.br/produtos/files/microport/joelho/Evolution%20Medial%20Pivot.pdf

Evolution - Medial-Pivot Knee System Evidence of this functional restoration is found in outcome measures that discern objective and subjective differences produced against competitive implant.