Total Knee ArthroplastyNCT03292003
Journey II Bi-Cruciate Stabilized (BCS) Total Knee System Retrospective Study
An observational study of Total Knee Arthroplasty, run by Smith & Nephew, Inc. at 12 sites in 3 countries.
Trial summary
The objective of this study is to estimate the safety and performance of Journey II BCS TKS. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Journey II BCS Total Knee System
- Type of treatment
- Medical device
- How many people
- 1,694 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 30 Dec 2016to 24 Sep 2018
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Sites will identify potential subjects by retrospectively reviewing their source documents in order to identify all patients who received TKA with the Journey II BCS TKS.
Who may be able to join
- Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II BCS Total Knee System for approved indication
- The TKA occurred at least 12 weeks prior to enrollment
- Subject records contain Patient Reported Outcome data obtained ≤3 months prior to as well as ≥6 months post-enrollment.
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
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States9 sites
University of Colorado Orthopaedics
Aurora, Colorado, 80045
Providence Regional Medical Center
Everett, Washington, 98021
Andrews Research and Education Foundation
Gulf Breeze, Florida, 32571
Methodist Sports Medicine
Indianapolis, Indiana, 46280
TN Orthopaedic Foundation for Education and Research
Knoxville, Tennessee, 37923
Hospital for Special Surgery
New York, New York
San Antonio Orthopaedic Specialists
San Antonio, Texas, 78258
University Orthopaedics Center
State College, Pennsylvania, 16602
Marra Knee and Shoulder Center
Wheeling, West Virginia, 26003
About this study
Official title: Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study
The objective of this study is to estimate the safety and performance of Journey II BCS TKS.
Read the detailed description
The objective of this study is to estimate the safety and performance of Journey II BCS TKS. Specifically, the study will establish revision rate, treatment- and device-related complications, and clinical outcomes in a large sample of subjects who received the study device. Subjects are screened consecutively, beginning at the earliest date of implantation at each investigative site. Further, reasons for revision will be collected and analyzed. An analysis will be performed to identify characteristics (patient, surgeon and surgical) associated with an increased risk for revision. Finally, clinical, functional and quality of life outcomes will be analyzed to the extent data is available, given the retrospective study design.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Journey II BCS Total Knee System
- Keywords
- rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, degenerative arthritis, failed osteotomy
- Medical subject headings
- Arthritis, Rheumatoid, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Journey II BCS Total Knee SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Journey II BCS Total Knee System | Subjects having TKA with Journey II BCS Total Knee System Receives: Device: Journey II BCS Total Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revision Rate of Total Knee System
Number of revisions
Measured: implantation through study completion, approximately 3 years
Secondary outcomes (10)
Adverse Events
Number of adverse events reported per ISO 14155 guidelines
Measured: implantation through study completion, approximately 3 years
Health care utilization: Hospitalization
Length of hospital stay for primary (index) surgery
Measured: implantation through study completion, approximately 3 years
Health care utilization: Hospitalization
Hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery (number and length of stay)
Measured: implantation through study completion, approximately 3 years
Health care utilization: Rehabilitation
number of sessions and duration of rehabilitation in weeks
Measured: implantation through study completion, approximately 3 years
Health care utilization: Outpatient visits
Number and type of outpatient visits
Measured: implantation through study completion, approximately 3 years
Health Care Utilization: Re-operations
number of re-operations and revisions
Measured: implantation through study completion, approximately 3 years
Patient reported outcomes
EQ-5D-3L
Measured: implantation through study completion, approximately 3 years
Clinical outcomes
Knee Society Score
Measured: implantation through study completion, approximately 3 years
Return to Work
Changes in employment status will be recorded with the date on which the change occurred and the change status.
Measured: implantation through study completion, approximately 3 years
Technical Difficulties Encountered During Device Implantation
Number of technical difficulties encountered with the device
Measured: implantation through study completion, approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start30 Dec 2016
- Primary completion30 Jan 2018
- Study completion24 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- Retrospective
- Enrolment
- 1,694 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beate Hanson, MD, PhD, Study chair, Vice President, Global Clinical Strategy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292003
- Sponsor's protocol ID
- 16-4049-08
- Status last verified
- Mar 2019
- First submitted
- 20 May 2017
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study
- ClinicalTrials.gov ID
- NCT03292003
- Acronym / sponsor ID
- 16-4049-08
- Conditions
- Total Knee Arthroplasty
- Keywords
- rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, degenerative arthritis, failed osteotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,694 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2016 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 24 Sep 2018 (actual)
- First posted
- 25 Sep 2017 (actual)
- 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.
The objective of this study is to estimate the safety and performance of Journey II BCS TKS.
Detailed description
The objective of this study is to estimate the safety and performance of Journey II BCS TKS. Specifically, the study will establish revision rate, treatment- and device-related complications, and clinical outcomes in a large sample of subjects who received the study device. Subjects are screened consecutively, beginning at the earliest date of implantation at each investigative site. Further, reasons for revision will be collected and analyzed. An analysis will be performed to identify characteristics (patient, surgeon and surgical) associated with an increased risk for revision. Finally, clinical, functional and quality of life outcomes will be analyzed to the extent data is available, given the retrospective study design.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Journey II BCS Total Knee System | – | Device: Journey II BCS Total Knee SystemSubjects having TKA with Journey II BCS Total Knee System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Sites will identify potential subjects by retrospectively reviewing their source documents in order to identify all patients who received TKA with the Journey II BCS TKS.
Key inclusion criteria (3 listed)
- Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II BCS Total Knee System for approved indication
- The TKA occurred at least 12 weeks prior to enrollment
- Subject records contain Patient Reported Outcome data obtained ≤3 months prior to as well as ≥6 months post-enrollment.
Key exclusion criteria (1 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
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 |
|---|---|---|
| Journey II BCS Total Knee System | Device | Journey II BCS Total Knee System |
Primary outcome
Revision Rate of Total Knee System
Time frame: implantation through study completion, approximately 3 years
Number of revisions
10 secondary outcomes
Adverse Events
Time frame: implantation through study completion, approximately 3 years
Health care utilization: Hospitalization
Time frame: implantation through study completion, approximately 3 years
Health care utilization: Hospitalization
Time frame: implantation through study completion, approximately 3 years
Health care utilization: Rehabilitation
Time frame: implantation through study completion, approximately 3 years
Health care utilization: Outpatient visits
Time frame: implantation through study completion, approximately 3 years
Health Care Utilization: Re-operations
Time frame: implantation through study completion, approximately 3 years
Patient reported outcomes
Time frame: implantation through study completion, approximately 3 years
Clinical outcomes
Time frame: implantation through study completion, approximately 3 years
Return to Work
Time frame: implantation through study completion, approximately 3 years
Technical Difficulties Encountered During Device Implantation
Time frame: implantation through study completion, approximately 3 years
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 28 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Total Knee Arthroplasty
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Application of Perinatal Derivatives in Total Knee Arthroplasty
Total Knee Arthroplasty, Knee Osteoarthristis
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Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
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Effects of Different Bispectral Index Target Depths on Early Postoperative Recovery Quality in Elderly Patients Undergoing Total Knee Arthroplasty
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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.
Beate Hanson, MD, PhD study chair
Vice President, Global Clinical Strategy
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty, run by Smith & Nephew, Inc. at 12 sites in 3 countries.
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 3 inclusion and 1 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 28 Mar 2019. 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, Belgium, Switzerland. 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?
Revision Rate of Total Knee System (time frame: implantation through study completion, approximately 3 years). 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 28 Mar 2019.