Total Knee Replacement for Osteoarthritis

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

170 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment JOURNEY™ II CR Total Knee System for osteoarthritis?

Research shows that the JOURNEY II knee system improves knee function and reduces complications compared to earlier designs. It closely mimics normal knee movement, leading to better pain relief and mobility outcomes. ^{1 2 3 4 5}

Is the JOURNEY II CR Total Knee System safe for humans?

The JOURNEY II Bi-Cruciate Stabilized Total Knee System has been used in over 100,000 knee replacements worldwide, and studies have assessed its short-term safety in clinical practice. It was designed to address issues like inflammation and dislocation seen in earlier models, suggesting improvements in safety. ^{1 2 4 6 7}

How is the JOURNEY II CR Total Knee System treatment different from other treatments for osteoarthritis?

The JOURNEY II CR Total Knee System is unique because it is designed to mimic the natural movement of the knee more closely than older knee replacement systems, potentially improving patient outcomes and reducing complications like inflammation and dislocation. ^{1 2 4 6 7}

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and effectiveness of the JOURNEY™ II CR Total Knee System in subjects with degenerative joint disease (DJD) requiring primary total knee replacement.

Research Team

Lucy O'Mara

Principal Investigator

Smith & Nephew, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. 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]

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

Short-term safety and effectiveness of a second-generation motion-guided total knee system. [2022]

3. England pubmed.ncbi.nlm.nih.gov

CAPAbility: comparison of the JOURNEY II Bi-Cruciate Stabilised and GENESIS II total knee arthroplasty in performance and functional ability: protocol of a randomised controlled trial. [2020]

4. China pubmed.ncbi.nlm.nih.gov

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

5. Germany pubmed.ncbi.nlm.nih.gov

The Journey Bicruciate Knee Replacement: Design Modifications Yield Better Early Functional Results and Reduce Complications. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Changes in total knee arthroplasty design affect in-vivo kinematics in a redesigned total knee system: A fluoroscopy study. [2019]

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

Midterm Performance of a Guided-Motion Bicruciate-Stabilized Total Knee System: Results From the International Study of Over 2000 Consecutive Primary Total Knee Arthroplasties. [2020]