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Orthopedic Implant

Total Knee Replacement for Osteoarthritis (NIMBLE Trial)

N/A
Waitlist Available
Research Sponsored by Smith & Nephew, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject received primary total knee arthroplasty with the JOURNEY™ II BCS Total Knee System due to degenerative joint disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively
Awards & highlights

NIMBLE Trial Summary

This trial is testing a new knee replacement system to see if it is safe and effective for people with degenerative knee disease.

Who is the study for?
This trial is for adults with degenerative knee disease needing a total knee replacement, who can commit to 10 years of follow-up and consent to study protocols. Excluded are those with certain other joint replacements, active infections, severe diseases like cancer or uncontrolled diabetes, pregnant individuals, BMI over 40, or enrolled in another study.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of the JOURNEY II BCS Total Knee System in patients undergoing total knee arthroplasty (replacement) due to osteoarthritis. It aims to assess patient outcomes over a decade.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks associated with total knee arthroplasty may include pain at the surgery site, infection risk post-surgery, blood clots in legs or lungs, nerve damage around the operated area and problems related to anesthesia.

NIMBLE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had a knee replacement with the JOURNEY II BCS system due to joint disease.

NIMBLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of ITB Friction Pain
Secondary outcome measures
Adverse Events
Knee Society Score
Radiographic Evaluation

NIMBLE Trial Design

1Treatment groups
Experimental Treatment
Group I: Journey II BCS TKAExperimental Treatment1 Intervention
Subjects having TKA with Journey II BCS Total Knee System

Find a Location

Who is running the clinical trial?

Smith & Nephew, Inc.Lead Sponsor
165 Previous Clinical Trials
22,272 Total Patients Enrolled
31 Trials studying Osteoarthritis
4,429 Patients Enrolled for Osteoarthritis
Rachael WinterStudy Directorrachael.winter@smith-nephew.com
8 Previous Clinical Trials
1,122 Total Patients Enrolled

Media Library

JOURNEY II BCS Total Knee System (Orthopedic Implant) Clinical Trial Eligibility Overview. Trial Name: NCT01705067 — N/A
Osteoarthritis Research Study Groups: Journey II BCS TKA
Osteoarthritis Clinical Trial 2023: JOURNEY II BCS Total Knee System Highlights & Side Effects. Trial Name: NCT01705067 — N/A
JOURNEY II BCS Total Knee System (Orthopedic Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01705067 — N/A
Osteoarthritis Patient Testimony for trial: Trial Name: NCT01705067 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings available to join this trial?

"According to clinicaltrials.gov, this medical research initiative is no longer enrolling people into the study. Initially published on June 1st 2012, and last updated on November 29th 2021 - 693 other trials are currently searching for volunteers to participate in them."

Answered by AI

Are there multiple locales engaged in this research endeavor within city limits?

"The current recruitment phase of this clinical trial involves 12 different sites, including Fort Wayne, Kirkland and Los Angeles. To reduce the burden associated with travelling for participation in the trial, it is advised to register at a site close by."

Answered by AI

Who else is applying?

What state do they live in?
Other
Tennessee
North Carolina
Washington
How old are they?
65+
What site did they apply to?
Joint Replacement Institute at St. Vincent Medical Center
Tennessee Orthopaedic Clinics
Evergreen Orthopaedic Clinic
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
2
0

Why did patients apply to this trial?

I'm probably going to have to have my left knee replaced at some point. My left knee causes me severe pain. I had my right knee replaced 10 or more years ago. It also effects my balance.
PatientReceived 1 prior treatment
I’ve had a lubricant shot into my knee, it did not help. I’m dealing with a diagnosis of PSP and a huge balance issue when walking and the pain in my knee makes the walking even my difficult.
PatientReceived 1 prior treatment
I had a partial knee replacement eight years ago, and it has never been okay. I am tired of being in pain. I also fell privileged when I can help promote further research for future patients.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

What exactly is it? Would there be costs to me, and if so, how much? How much time is involved? Is there a cost to me?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of the Journey II BCS Total Knee System
2012. "Safety and Efficacy of the Journey II BCS Total Knee System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01705067.
All > Osteoarthritis Knee
~16 spots leftby Apr 2025
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