OsteoarthritisNCT02820766
Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting
An observational study of Osteoarthritis and Degenerative Arthritis, run by Smith & Nephew, Inc. at 3 sites in United States.
Trial summary
The primary objective of the study is to determine how the short-term outcome of subjects implanted with the JOURNEY™ II BCS Total Knee System compares to subjects implanted with other PS total knee systems, and to determine if there is a difference in health care resources consumed that may result in economic savings… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis, Degenerative Arthritis, Traumatic Arthritis
- How many people
- 22 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2016to 27 Apr 2017
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who have a primary diagnosis of osteoarthritis, degenerative arthritis, or traumatic arthritis and who will receive either the Journey II BCS knee or any other posterior stabilized knee.
Who may be able to join
- Undergone unilateral primary total knee replacement with a JOURNEY™ II BCS Total Knee System or other Non-Smith \& Nephew Posterior Stabilized Knee System
- Will be initiating outpatient PT ≤ 7 days post-operatively
- Has a primary diagnosis of osteoarthritis, degenerative arthritis, or traumatic arthritis
- Has pre-operative ROM ≥ 90°
- Is skeletally mature in the PI judgment
- Is 21 years of age of older
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- Is willing and able to participate in required follow-up visits at the study site and to complete study procedures and questionnaires
- Has consented to participate in the study by signing the IRB/EC approved informed consent for the study
- Agrees to follow post- operative physical therapy program
Who cannot join
- Significant preoperative varus or valgus deformities (>15º)
- Has received a constrained or deep dish tibial insert
- Morbid obesity (BMI > 40)
- Has not obtained required pre-rehabilitation, pre-operative and intra-operative records by week 2 visit
- Other comorbidities that may impact outcomes such as osteoporosis, uncontrolled diabetes and active infection
- Fibromyalgia requiring treatment
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- Current or impending incarceration or is a prisoner
- In the opinion of the PI has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse
- Is known to be at risk for lost to follow-up, or failure to return for scheduled visits
- Undergone or is planning to undergo total knee replacement of the contralateral knee within 6 months of this total knee replacement
- Requires a Legally Authorized Representative to consent to the study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Anne Arundel Medical Cneter
Annapolis, Maryland, 21401
Slocum Research & Educational Foundation
Eugene, Oregon, 97401
University Orthopaedic Center
State College, Pennsylvania, 16801
About this study
Official title: A Non-Randomized, Prospective Study of Short Term Outcomes Following Total Knee Replacement With JOURNEY™ II BCS Total Knee System Compared to Other Posterior Stabilized Total Knee Systems in a Physical Therapy Setting
The primary objective of the study is to determine how the short-term outcome of subjects implanted with the JOURNEY™ II BCS Total Knee System compares to subjects implanted with other PS total knee systems, and to determine if there is a difference in health care resources consumed that may result in economic savings to patients, the facility and/or the payer.
To address the study objectives, patient self-assessment questionnaires, and other objective measures of post-operative function and health care resource utilization will be used for data collection.
- Conditions
- Osteoarthritis, Degenerative Arthritis, Traumatic Arthritis
- Keywords
- Posterior Stabilized Knee, Total Knee Arthroscopy, Journey II BCS
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Journey II BCS Knee | Physical Therapy Observational | |
| All Other Posterior Stabilized Knees | Physical Therapy Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Knee Range of Motion (ROM) at the first outpatient Physical Therapy (PT) visit (≤7 days of surgery) between the 2 treatment groups
The absolute Range of Motion of index knee will be compared between groups
Measured: ≤7 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startSep 2016
- Primary completion27 Apr 2017
- Study completion27 Apr 2017
Why it stopped: Logistics of study did not allow for consistent data collection
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beate Hanson, MD, Study director, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820766
- Sponsor's protocol ID
- Journey II BCS CMS Study
- Status last verified
- Aug 2017
- First submitted
- 29 Jun 2016
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Study terminated therefore no data sharing planned
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Randomized, Prospective Study of Short Term Outcomes Following Total Knee Replacement With JOURNEY™ II BCS Total Knee System Compared to Other Posterior Stabilized Total Knee Systems in a Physical Therapy Setting
- ClinicalTrials.gov ID
- NCT02820766
- Acronym / sponsor ID
- Journey II BCS CMS Study
- Conditions
- Osteoarthritis, Degenerative Arthritis, Traumatic Arthritis
- Keywords
- Posterior Stabilized Knee, Total Knee Arthroscopy, Journey II BCS
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Logistics of study did not allow for consistent data collection
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- 27 Apr 2017 (actual)
- Study completion
- 27 Apr 2017 (actual)
- First posted
- 1 Jul 2016 (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.
The primary objective of the study is to determine how the short-term outcome of subjects implanted with the JOURNEY™ II BCS Total Knee System compares to subjects implanted with other PS total knee systems, and to determine if there is a difference in health care resources consumed that may result in economic savings to patients, the facility and/or the payer.
To address the study objectives, patient self-assessment questionnaires, and other objective measures of post-operative function and health care resource utilization will be used for data collection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Journey II BCS Knee | – | –Physical Therapy Observational |
| All Other Posterior Stabilized Knees | – | –Physical Therapy Observational |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have a primary diagnosis of osteoarthritis, degenerative arthritis, or traumatic arthritis and who will receive either the Journey II BCS knee or any other posterior stabilized knee.
Key inclusion criteria (9 listed)
- Undergone unilateral primary total knee replacement with a JOURNEY™ II BCS Total Knee System or other Non-Smith \& Nephew Posterior Stabilized Knee System
- Will be initiating outpatient PT ≤ 7 days post-operatively
- Has a primary diagnosis of osteoarthritis, degenerative arthritis, or traumatic arthritis
- Has pre-operative ROM ≥ 90°
- Is skeletally mature in the PI judgment
Key exclusion criteria (11 listed)
- Significant preoperative varus or valgus deformities (>15º)
- Has received a constrained or deep dish tibial insert
- Morbid obesity (BMI > 40)
- Has not obtained required pre-rehabilitation, pre-operative and intra-operative records by week 2 visit
- Other comorbidities that may impact outcomes such as osteoporosis, uncontrolled diabetes and active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in Knee Range of Motion (ROM) at the first outpatient Physical Therapy (PT) visit (≤7 days of surgery) between the 2 treatment groups
Time frame: ≤7 days of surgery
The absolute Range of Motion of index knee will be compared between groups
Results and safety
The study was stopped early (reason given: Logistics of study did not allow for consistent data collection). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- Individual participant dataSharing planned: No. Study terminated therefore no data sharing planned
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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 study director
Smith & Nephew, Inc.
3 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 and Degenerative Arthritis, run by Smith & Nephew, Inc. at 3 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 9 inclusion and 11 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: stopped early, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 was stopped early (reason given: Logistics of study did not allow for consistent data collection). Results are not available in the source record.
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?
Difference in Knee Range of Motion (ROM) at the first outpatient Physical Therapy (PT) visit (≤7 days of surgery) between the 2 treatment groups (time frame: ≤7 days of surgery). 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 10 Aug 2017.