Total Knee Arthroplasty for Osteoarthritis

Overseen By Ailar Ramadi, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: High BMI, Knee deformity, Infection, others

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

Compensation: Varies

Number of Visits: 2

Duration: Surgery and immediate recovery

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare three types of knee implants to determine which works best for people with knee osteoarthritis. The study will examine how these implants affect knee movements, walking patterns, pain, and overall function after surgery. Participants must have knee osteoarthritis and plan to undergo primary knee replacement surgery. As an unphased trial, this study provides a unique opportunity to contribute to valuable research that could enhance future knee replacement outcomes.

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 coordinators or your doctor.

What prior data suggests that these knee replacement implants are safe?

Research shows that the Journey II knee prosthesis is generally well-accepted by patients. Studies have examined its long-term safety, and while specific side effects are not listed, the emphasis on safety suggests trust in its use.

For the Stryker knee prosthesis, surgeons have performed over one million surgeries using this technology, indicating a strong safety record. Reports show good results without major soft tissue problems, suggesting it is well-accepted by patients.

The Zimmer Persona knee prosthesis has been in use for over 20 years, with studies examining implant longevity and patient outcomes after surgery. This long history and focus on patient outcomes suggest it is also well-accepted by patients.

These treatments have seen widespread use, supporting their safety. Although specific side effects are not mentioned, the extensive use and focus on safety in studies provide reassurance about their safety for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Journey II knee prosthesis because it offers a unique approach to total knee arthroplasty for osteoarthritis. Unlike other standard prostheses, Journey II is designed to more closely mimic the natural movement of the knee, potentially leading to a more comfortable and functional joint for patients. This prosthesis features advanced materials and design that aim to enhance durability and reduce wear, which could translate to longer-lasting results and improved outcomes for individuals suffering from osteoarthritis.

What evidence suggests that this trial's treatments could be effective for osteoarthritis?

Research shows that the Journey II knee implant, one of the treatments in this trial, performs well for people with osteoarthritis who need knee replacements. Studies have found that it remains effective for many years, with numerous implants functioning well after 10 years. Designed for those who wish to stay active, the Journey II supports activities requiring strong knee function. Although some studies present mixed results compared to other implants, the Journey II remains popular due to its design, which promotes more natural knee movement. It has been widely used in over 100,000 procedures in the U.S. This trial will also compare the Journey II with the Stryker and Zimmer knee implants, which are other treatment options under study. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for men and non-pregnant women aged 50-75 with Non-Inflammatory Degenerative Joint Disease needing knee replacement. They must be able to follow the study's procedures and have signed consent. Excluded are those with a BMI ≥ 40, recent or upcoming lower extremity surgeries, sensitivity to device materials, infections in the knee, or severe knee deformities.

Inclusion Criteria

I am willing and able to follow through with all after-surgery check-ups and rehab.

Participant has signed an approved informed consent form

I am between 50 and 75 years old and not pregnant.

Exclusion Criteria

I might have an infection in or near my knee where a device will be implanted.

My knee is severely bent or I can't straighten it fully.

I need both knees replaced or had one knee partially/fully replaced recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-operative

Preoperative data collection including demographics, medical history, gait analysis, and functional evaluation

1 month

1 visit (in-person)

Treatment

Participants undergo total knee arthroplasty using either the Journey II, Stryker, or Zimmer prostheses

Surgery and immediate recovery

Hospital stay

Follow-up

Gait analysis and patient-reported outcomes collected at 1-year and 2-year postoperative intervals

2 years

Multiple visits (in-person)

Long-term follow-up

Potential longer-term follow-up to evaluate long-term performance

What Are the Treatments Tested in This Trial?

Interventions

• Journey II
• Stryker
• Zimmer

Trial Overview The study tests if Journey II knee implants lead to better outcomes than standard Stryker and Zimmer implants in terms of movement, walking patterns, pain relief, and function post-surgery.

How Is the Trial Designed?

Group I: Journey II Experimental Treatment 1 Intervention

Smith and Nephew Richards (SNR) Journey II Knee prosthesis

Group II: Zimmer Active Control 1 Intervention

Zimmer Persona® The Personalized Knee prosthesis

Group III: Stryker Active Control 1 Intervention

Stryker Triathlon Total Knee prosthesis

Journey II is already approved in United States, European Union for the following indications:

Approved in United States as Journey II for:

• Rheumatoid arthritis
• Post-traumatic arthritis
• Osteoarthritis
• Degenerative arthritis
• Failed osteotomies
• Unicompartmental replacement
• Total knee replacement

Approved in European Union as Journey II for:

• Rheumatoid arthritis
• Post-traumatic arthritis
• Osteoarthritis
• Degenerative arthritis
• Failed osteotomies
• Unicompartmental replacement
• Total knee replacement

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Published Research Related to This Trial

The Triathlon total knee replacement (TKR) showed excellent outcomes, with a 95.4% survivorship rate at 10 years post-surgery, indicating its long-term reliability for patients.

Patients experienced significant improvements in pain and function within the first three months after surgery, with satisfaction rates ranging from 79% to 94% over the follow-up period, demonstrating the effectiveness of the Triathlon prosthesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ten-Year Results of the Triathlon Knee Replacement: A Cohort Study. Wylde, V., Penfold, C., Rose, A., et al.[2021]

The Persona Knee implant system demonstrated high safety and efficacy in total knee arthroplasty, with a 2-year survival rate of 99% and only one revision due to infection among 146 surgeries performed.

Patient-reported outcomes significantly improved post-surgery, with the Oxford Knee Score increasing from an average of 22.1 to 41.8, indicating enhanced pain relief, function, and quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient reported outcomes and implant survivorship after Total knee arthroplasty with the persona knee implant system: two year follow up. Mathijssen, NMC., Verburg, H., London, NJ., et al.[2020]

In a study involving 60 patients, the Triathlon cemented knee prosthesis showed similar early migration characteristics compared to the Duracon cemented knee prosthesis, as measured by radiostereometric analysis over two years.

Both prostheses demonstrated comparable clinical outcomes, indicating that the Triathlon is likely to perform at least as well as the Duracon in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does a new knee design perform as well as the design it replaces? Molt, M., Ljung, P., Toksvig-Larsen, S.[2021]

Patients with the Triathlon(®) total knee replacement reported significantly better outcomes in pain relief, function, quality of life, and satisfaction compared to those with the Kinemax Plus prosthesis, based on a study of 453 knees (233 Kinemax Plus and 220 Triathlon) with follow-up at 3 months and 1 year post-surgery.

The Triathlon(®) prosthesis appears to facilitate a quicker return to function and greater pain reduction within the first three months after surgery, indicating its potential advantages over the previous design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of patient reported outcomes after Triathlon(®) and Kinemax Plus prostheses. Dixon, S., Blom, AW., Whitehouse, MR., et al.[2021]

The study involving 80 participants found no significant difference in patient-reported outcomes (Oxford Knee Score) between the newer Journey II BCS and the older Genesis II total knee replacement designs at 6 months post-surgery.

However, the Genesis II group showed superior biomechanical outcomes, including greater walking range of motion and higher peak knee flexion velocity, suggesting it may offer better functional performance compared to the Journey II BCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the Journey II bicruciate stabilised (JII-BCS) and GENESIS II total knee arthroplasty for functional ability and motor impairment: the CAPAbility, blinded, randomised controlled trial. McNamara, I., Pomeroy, V., Clark, AB., et al.[2023]

Total knee arthroplasty (TKA) using the JOURNEY prosthesis showed promising early results in 32 patients, with significant improvements in knee function and pain scores observed at 3, 6, and 12 months post-operation.

While the procedure was generally safe, with all incisions healing well, complications such as hydrarthrosis and a couple of serious issues (femur fracture and implant dislocation) were noted, indicating the need for careful monitoring in the early postoperative period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Early clinical results of total knee arthroplasty with journey prosthesis]. Zhou, B., Tang, K., Hajo, T., et al.[2019]

In a study of 41 patients who underwent bicompartmental knee arthroplasty with the Journey-Deuce prosthesis, significant improvements in knee function and quality of life were observed at 10 years post-surgery, with no major component revisions required.

Despite the presence of progressive radiolucencies in 32% of tibial and 45% of femoral components, there were no clinical signs of loosening, indicating that the prosthesis remains stable over the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Journey-Deuce bicompartmental knee arthroplasty with the addition of computer navigation achieves good clinical outcomes and implant survival at 10 years. Aujla, RS., Woodhouse, J., Ebert, JR., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03136887

JOURNEY II XR Safety and Effectiveness PMCF This study was designed to demonstrate the safety and performance of the JOURNEY II XR total knee system by evaluating implant survival rates at 10 years ...

2. clinicaltrial.be clinicaltrial.be/en/details/8956?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

JOURNEY II XR Safety and Effectiveness PMCF The main aim of this study is to generate long-term safety and performance data for the JOURNEY™ II XR Total Knee System. Effectiveness ...

3. smith-nephew.com smith-nephew.com/en-us/health-care-professionals/products/orthopaedics/journey-ii-tka

JOURNEY ◊ II Total Knee Arthroplasty JOURNEY◊ II Total Knee Arthroplasty. Total knee arthroplasty patients report unmet levels of satisfaction, particularly for more active or demanding activities.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9815016/

Comparison of the Journey II bicruciate stabilised (JII-BCS ... The findings do not support the hypothesis that the Journey II BCS produces a better outcome than the Genesis II for the primary outcome of the OKS at 6 months ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0883540319301469

Primary Arthroplasty Midterm Performance of a Guided ... Journey II BCS is currently the only marketed guided-motion knee implant. The system has been used in over 70,000 TKAs in the United States and more than 30,000 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03903731

Safety and Performance of Journey II BCS Total Knee ... It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

7. trial.medpath.com trial.medpath.com/clinical-trial/608285ea57d4740e/nct03798847-safety-performance-journey-ii-xr-total-knee-system

Safety and Performance of Journey II XR Total Knee System The objective of this study is to estimate the safety and performance of Journey II XR TKS based on retrospective data.