Comparing Journey Total Knee Replacement with Standard Knee Replacements

Comparative Effectiveness of the Journey Total Knee Arthroplasty Relative to Two Standard of Care Total Knee Arthroplasty Prostheses: A Randomized Controlled Trial

This study is testing if a new type of knee replacement implant can help people move better and feel less pain compared to standard implants.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 50 Years to 75 Years
• Sex: All
• Sponsor: University of Alberta (other)
• Locations: 1 site (Edmonton, Alberta)
• Trial ID: NCT03895489 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of the Journey II total knee arthroplasty implant compared to two standard knee replacement implants from Stryker and Zimmer. It will assess differences in knee movements, forces, walking patterns, pain levels, and overall function post-surgery. By measuring specific knee kinetics and kinematics, the study seeks to determine if the Journey II implant can enhance patient outcomes beyond traditional implants. The findings could inform future rehabilitation protocols and improve quality of life for patients undergoing knee replacement.

Who should consider this trial

Good fit: Ideal candidates for this study are males or non-pregnant females aged 50 to 75 with non-inflammatory degenerative joint disease who are suitable for primary total knee replacement.

Not a fit: Patients with a BMI of 40 kg/m2 or higher, significant knee deformities, or recent orthopedic interventions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management and functional outcomes for patients undergoing knee replacement surgery.

How similar studies have performed: Other studies have explored various knee replacement implants, but the specific comparison of the Journey II implant with standard options is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Participant has signed an approved informed consent form.
2. Participant is a male or non-pregnant female and aged 50 to 75 years at the time of study device implantation.
3. Participant has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
4. Participant is a candidate for a primary posterior-stabilized total knee replacement.
5. Participant is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

1. Participant has a Body Mass Index (BMI) ≥ 40 kg/m2.
2. Participant has a varus or valgus deformity greater than 15º or flexion contracture greater than 20º or knee flexion range of motion \< 90º in either lower extremity.
3. Participant has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
4. Participant has received any orthopaedic surgical intervention to the lower extremities within the past 6 months or is expected to require any orthopaedic surgical intervention to the lower extremities, other than the TKA, within the next year.
5. Participant requires bilateral total knee replacements, or has a history of contralateral partial or total knee replacement within the past 6 months.
6. Participant has other medical conditions which limit the ability to evaluate the safety and efficacy of the device.
7. Participant requires revision surgery of a previously implanted total knee replacement or knee fusion to the affected joint.
8. Participant has a known sensitivity to device materials.

Where this trial is running

Edmonton, Alberta

• Edmonton Bone and Joint Centre — Edmonton, Alberta, Canada (RECRUITING)

Study contacts

• Study coordinator: Ailar Ramadi, PhD

Conditions: Osteoarthritis, Knee