A Prospective, Multicenter, Study to Evaluate the Safety and Effectiveness of the JOURNEY II XR Total Knee System with VERILAST Technology - JOURNEY II XR with VERILAST in Japan

Smith & Nephew KK0 sites106 target enrollmentNovember 1, 2018

ConditionsThe subject components are indicated for total knee arthroplasty performed for rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, degenerative arthritis, failed osteotomies, or failed unicompartmental replacement.

Overview

Phase: N/A
Intervention: Not specified
Conditions: The subject components are indicated for total knee arthroplasty performed for rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, degenerative arthritis, failed osteotomies, or failed unicompartmental replacement.
Sponsor: Smith & Nephew KK
Enrollment: 106
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Clinical success of the JOURNEY II XR Total Knee System met the primary objective as it is no worse than the 98% historical control with a margin of 7% (i.e. 91% non-inferiority limit), p=0.006.

Registry

who.int

Start Date

November 1, 2018

End Date

February 20, 2023

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Smith & Nephew KK

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•1\. have any of the following conditions in the index joint: a. Intra\-articular corticosteroid therapy (or any other intra\-articular therapy) in the study knee within 3 months of study enrollment b. Significant varus or valgus deformities (\>15 angle) c. Incomplete or insufficient tissue surrounding the knee d. Collateral ligament insufficiency e. Inadequate bone stock to support the device (e.g., severe osteopenia/osteoporosis) or will require use of femoral and tibial stems f. History of prior TKA 2\. have any of the following conditions in the contralateral joint: a. a previous TKA as a revision for a failed total or unicondylar knee arthroplasty b. a primary TKA or unicondylar knee arthroplasty that is not fully healed and well\-functioning as determined by the Investigator 3\. have any of the following conditions of the hip: a. a previous contralateral or ipsilateral revision hip arthroplasty b. ipsilateral hip arthritis resulting in flexion contracture c. previously received an ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty that is not fully healed and well\-functioning as determined by the Investigator 4\. have a diagnosis of an immunosuppressive disorder 5\. have an active infection, treated or untreated, systemic or at the site of the planned surgery 6\. have conditions that may interfere with the TKA survival or outcome, including but not limited to: Paget's disease, Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, renal insufficiency or neuromuscular disease 7\. have a BMI \> 40 8\. be facing current or impending incarceration 9\. have a known allergy to study device or one or more of its components 10\. have, in the opinion of the Investigator, an emotional or neurological condition that would pre\-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse