Safety and Efficacy of the Journey II BCS Total Knee System



Status:Active, not recruiting
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:Any
Updated:6/20/2018
Start Date:June 2012
End Date:June 2024

Use our guide to learn which trials are right for you!

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)

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

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.

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
We found this trial at
12
sites
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Columbus, Ohio 43215
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Fort Wayne, Indiana 46804
?
mi
from
Fort Wayne, IN
Click here to add this to my saved trials
Indianapolis, Indiana 46280
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Kirkland, Washington 98034
?
mi
from
Kirkland, WA
Click here to add this to my saved trials
Knoxville, Tennessee 37923
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
535 E 70th St
New York, New York 10021
(212) 606-1000
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
?
mi
from
New York, NY
Click here to add this to my saved trials
San Antonio, Texas 78229
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Winston-Salem, North Carolina 27157
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials