Osteoarthritis, KneeNIMBLENCT01705067
Safety and Efficacy of the Journey II BCS Total Knee System
An observational study of Osteoarthritis, Knee, run by Smith & Nephew, Inc. at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- TKA with Journey II BCS Total Knee System
- Type of treatment
- Medical device
- How many people
- 209 participants
- Where
- 12 sitesUnited States
- Study dates
- Jun 2012to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects receiving the JOURNEY™ II BCS Total Knee System
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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 locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
OrthoCarolina
Charlotte, North Carolina, 28207
Wellington Orthopaedics
Cincinnati, Ohio, 45220
Cincinnati Orthopaedic Research Institute
Cincinnati, Ohio, 45249
Minimally Invasive Orthopaedics
Columbus, Ohio, 43215
Fort Wayne Orthopedics
Fort Wayne, Indiana, 46804
Methodist Sports Medicine/The Orthopedic Specialist
Indianapolis, Indiana, 46280
Evergreen Orthopaedic Clinic
Kirkland, Washington, 98034
Tennessee Orthopaedic Clinics
Knoxville, Tennessee, 37923
Joint Replacement Institute at St. Vincent Medical Center
Los Angeles, California, 90057
Hospital for Special Surgery
New York, New York, 10021-4892
San Antonio Orthopaedic Specialists
San Antonio, Texas, 78229
Wake Forest University
Winston-Salem, North Carolina, 27157-1070
About this study
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)
Assess the safety and efficacy of the JOURNEY II BCS Total Knee System in subjects with degenerative knee disease requiring primary total knee replacement.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- TKA with Journey II BCS Total Knee System
- Keywords
- Osteoarthritis, Degenerative Knee Disease, Total Knee Arthroplasty (TKA)
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TKA with Journey II BCS Total Knee SystemDevice
Also called Journey II BCS
TKA with Journey II BCS Total Knee System
| Study group | Role | What they receive |
|---|---|---|
| Journey II BCS TKA | Subjects who previously received TKA with Journey II BCS Total Knee System Receives: Device: TKA with Journey II BCS Total Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of ITB Friction Pain
Measured: 6 months post-operatively
Secondary outcomes (3)
Adverse Events
Measured: 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively
Radiographic Evaluation
Measured: Baseline and 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively
Knee Society Score
Measured: 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startJun 2012
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705067
- Sponsor's protocol ID
- 2011JBCK151
- Acronym
- NIMBLE
- Status last verified
- Jun 2024
- First submitted
- 21 Jun 2012
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01705067
- Acronym / sponsor ID
- NIMBLE / 2011JBCK151
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Degenerative Knee Disease, Total Knee Arthroplasty (TKA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 12 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Journey II BCS TKA | – | Device: TKA with Journey II BCS Total Knee SystemSubjects who previously received TKA with Journey II BCS Total Knee System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects receiving the JOURNEY™ II BCS Total Knee System
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TKA with Journey II BCS Total Knee SystemAlso: Journey II BCSTKA with Journey II BCS Total Knee System | Device | Journey II BCS TKA |
Primary outcome
Rate of ITB Friction Pain
Time frame: 6 months post-operatively
3 secondary outcomes
Adverse Events
Time frame: 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively
Radiographic Evaluation
Time frame: Baseline and 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively
Knee Society Score
Time frame: 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by Smith & Nephew, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of ITB Friction Pain (time frame: 6 months post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.