Safety and Efficacy of the Journey II BCS Total Knee System (NIMBLE)

Smith & Nephew

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Device: TKA with Journey II BCS Total Knee System

Study type: Observational

Funder types: Industry

Identifiers

NCT01705067

2011JBCK151

Details and patient eligibility

About

Assess the safety and efficacy of the JOURNEY II BCS Total Knee System in subjects with degenerative knee disease requiring primary total knee replacement.

Full description

Assess the safety and efficacy of the JOURNEY II BCS Total Knee System in subjects with degenerative knee disease requiring primary total knee replacement. Pre-operative and operative assessments collected retrospectively. All postoperative assessments beginning at the 6 month post-operative time point collected prospectively.

Enrollment: 209 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject received primary total knee arthroplasty with the JOURNEY™ II BCS Total Knee System due to degenerative joint disease
• Subject is willing to sign and date an IRB approved consent form
• Subject is of legal age to consent
• Subject plans to be available through ten (10) years postoperative follow-up
• Subject agrees to follow the study protocol

Exclusion criteria

• Subject received the JOURNEY™ II BCS Total Knee System on the affected knee as a revision for a previously failed total or unicondylar knee arthroplasty

• Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty

• Subject possesses a contralateral or ipsilateral revision hip arthroplasty

• Subject has ipsilateral hip arthritis resulting in flexion contracture

• At the time of enrollment, subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator:

  • Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty
  • Contralateral primary total knee or unicondylar knee arthroplasty

• At the time of surgery, subject had an active infection or sepsis (treated or untreated)

• At the time of surgery, subject had presence of malignant tumor, metastatic, or neoplastic disease

• At the time of surgery, subject had conditions that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)

• At the time of surgery, subject had contralateral lower extremity condition causing abnormal ambulation

• Subject is pregnant or plans to become pregnant during the study

• Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study

• At the time of surgery, subject had a BMI>40

• At the time of enrollment, subject has a BMI>40

• Subject is enrolled in another investigational drug, biologic, or device study

• Subject is facing current or impending incarceration

Trial design

209 participants in 1 patient group

Journey II BCS TKA

Description:

Subjects who previously received TKA with Journey II BCS Total Knee System

Treatment:

Device: TKA with Journey II BCS Total Knee System