Clinical trial NCT01705067: Safety and Efficacy of the Journey II BCS Total Knee System
Official title: A Retro-Prospective, Non-randomized, Consecutive Series, SIngle Cohort, Multicenter Adaptive Design Study to Evaluate the Outcomes of Total Knee Arthroplasty (TKA) Using JOURNEY™ II BCS TotaL Knee SystEm (The NIMBLE Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis
Degenerative Knee Disease
Total Knee Arthroplasty (TKA)
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-12
Enrollment: 209
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects receiving the JOURNEY™ II BCS Total Knee System

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of ITB Friction Pain
timeFrame: 6 months post-operatively
Secondary outcomes:
measure: Adverse Events
timeFrame: 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively
measure: Radiographic Evaluation
timeFrame: Baseline and 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively
measure: Knee Society Score
timeFrame: 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Joint Replacement Institute at St. Vincent Medical Center
state: California
city: Fort Wayne
country: United States
facility: Fort Wayne Orthopedics
state: Indiana
city: Indianapolis
country: United States
facility: Methodist Sports Medicine/The Orthopedic Specialist
state: Indiana
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Charlotte
country: United States
facility: OrthoCarolina
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Cincinnati
country: United States
facility: Wellington Orthopaedics
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Orthopaedic Research Institute
state: Ohio
city: Columbus
country: United States
facility: Minimally Invasive Orthopaedics
state: Ohio
city: Knoxville
country: United States
facility: Tennessee Orthopaedic Clinics
state: Tennessee
city: San Antonio
country: United States
facility: San Antonio Orthopaedic Specialists
state: Texas
city: Kirkland
country: United States
facility: Evergreen Orthopaedic Clinic
state: Washington
Study officials:
References: