Effectiveness of the Journey Total Knee Arthroplasty Versus Two Standard of Care Total Knee Arthroplasty Prostheses

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  50 to 75

Participation 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.