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?

The purpose of the study is to determine if knee replacement performed using Journey II implant is different from two other standard-of-care knee replacements using Stryker and Zimmer in terms of knee movements and forces, walking patterns, pain, and function after surgery.

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 makes the Journey II, Stryker, Zimmer knee replacement treatment unique for osteoarthritis?

The Journey II, Stryker, Zimmer knee replacement treatment is unique because it includes personalized implant designs like the Persona knee implant system, which aim to optimize clinical outcomes by better matching the patient's anatomy. Additionally, the Journey II BCS design is newer and may offer superior patient-reported outcomes and biomechanical performance compared to older designs. ^{1 2 3 4 5}

What data supports the effectiveness of this treatment for Total Knee Arthroplasty for Osteoarthritis?

Research shows that the Triathlon knee replacement provides excellent outcomes and high satisfaction rates, with 95.4% of implants lasting 10 years. Additionally, the Journey II BCS knee replacement has been shown to improve patient-reported outcomes compared to older designs. ^{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

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]

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]

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]

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 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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Comparison of patient reported outcomes after Triathlon(®) and Kinemax Plus prostheses. [2021]

2. China pubmed.ncbi.nlm.nih.gov

[Early clinical results of total knee arthroplasty with journey prosthesis]. [2019]

3. England 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Ten-Year Results of the Triathlon Knee Replacement: A Cohort Study. [2021]

5. England 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. [2020]

6. Germany 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Does a new knee design perform as well as the design it replaces? [2021]