OsteoarthritisAViKANCT01540851
Adding Value in Knee Arthroplasty Post-total Knee Replacement (TKR) Care Navigator Trial
A study testing Care Navigator and Standard Post-Operative TKA Care in people with Osteoarthritis and Degenerative Joint Disease, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The objectives of this research are to: Conduct a proof of concept randomized controlled trial with up to 300 patients undergoing primary total knee replacement (TKA) at Brigham and Women's Hospital (BWH). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Degenerative Joint Disease
- What is being tested?
- Care Navigator and Standard Post-Operative TKA Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2011to 10 May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo primary TKA at Brigham \& Women's Hospital
- Osteoarthritis is the principal underlying diagnosis
- Age >=40 at the projected date of TKA
- English-speaking
Who cannot join
- Osteoarthritis is not the principal underlying diagnosis (e.g. inflammatory arthritis)
- Dementia
- Psychological issues that preclude participation, as identified by participating surgeons
- Non-English speaker
- Diagnosis other than Osteoarthritis or secondary Osteoarthritis
- Age < 40 at the projected date of TKA
Show all 9Show fewer
- Lives in a nursing home
- Implantation of Unicompartamental Knee Arthroscopy or Interpositional Arthroplasty
- Bilateral TKA in same admission (simultaneous)or planned bilateral within 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham & Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Adding Value in Knee Arthroplasty Post TKR Care Navigator Trial
The objectives of this research are to:
Conduct a proof of concept randomized controlled trial with up to 300 patients undergoing primary total knee replacement (TKA) at Brigham and Women's Hospital (BWH). The trial will compare a "Care Navigator" post-discharge intervention versus "Usual Care" post discharge management of patients undergoing TKA. The intervention will focus on the challenging process of transitions from the acute care hospital to inpatient or outpatient rehabilitation, and from inpatient rehabilitation to home.
Read more
The principal goals of the trial are:
- To establish whether "Care Navigator" intervention improves functional outcomes as compared with the "Usual Care" treatment six months after TKA surgery.
- To establish whether "Care Navigator" intervention is cost effective six months after TKA surgery.
The investigators hypothesize that:
- Incorporating the Care Navigator role into the "Usual Care" treatment will increase TKA patients' rate of adherence to the rehabilitation protocol and improve functional outcomes.
- Addition of a Care Navigator is cost-effective.
Read the detailed description
The "Post-TKA Care Navigator" proof of concept intervention will be implemented as a randomized controlled trial. The investigators aim to identify and enroll a cohort of up to 300 subjects who have decided to undergo total knee replacement (TKA) at BWH. Subjects will be patients of the five orthopedic surgeons at Brigham and Women's Hospital who perform the most TKAs: Drs. Wright, Brick, Ready, Martin and Thornhill. Subjects will be followed from about two weeks prior to the operation to six months after discharge.
The investigators will assign patients into two groups, at random: 1) receiving current standard of post-operative care and 2) adding "Post-TKA Care Navigator". The role of the Care Navigator will be to follow up with patients via frequent telephone conversations, ranging from weekly during the first month to bi-weekly for the next 6 weeks to monthly by the 14th week post op. subjects assigned to the care navigator will receive up to 10 telephone calls over a period of 5 months. The goal of the Care Navigator would be to ensure or encourage compliance with physical therapy, triage patient concerns, questions and complaints, and identify those patients that require a call from a clinician to address a problem in the recovery process. For those issues that can be resolved easily at home the navigator would suggest strategies. The value of the post-TKA Care Navigator will be assessed by comparing functional status, satisfaction with surgery, utilization of health care, adherence to physical therapy, range of knee motion and intervention costs across the two randomized groups.
- Conditions
- Osteoarthritis, Degenerative Joint Disease
- Being tested
- Care Navigator, Standard Post-Operative TKA Care
- Keywords
- Osteoarthritis, Total Knee Replacement, total Knee Arthroplasty, Post operative recovery, TKA, Post-operative recovery TKR, Care Navigator
- Medical subject headings
- Osteoarthritis, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care NavigatorBehavioural
Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharge from the hospital for 5 months after their total knee replacement.
Standard Post-Operative TKA CareOther
Subjects assigned to the Standard Post-Operative TKA Care group will receive the current standard of care for post-operative care
| Study group | Role | What they receive |
|---|---|---|
| Care Navigator Intervention Group | Active comparator | Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively Receives: Behavioral: Care Navigator |
| Usual Care Group | Active comparator | Subjects in the Usual Care group receive the current standard post-operative TKA care Receives: Other: Standard Post-Operative TKA Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in WOMAC Physical Function
The change in functional status will be measured using the WOMAC Physical Function scale at Baseline and 6 months
Measured: Change in functional status from baseline to 6 months
Secondary outcomes (2)
Satisfaction
Percentage of patients in each study arm who reported being very satisfied with the results of TKA
Measured: Measured at 6 months post TKA
Range of Motion
Percentage of participants able to bend knee at least 120 degrees
Measured: 6 months after TKA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2012 (estimated)
- Study start24 Jul 2011
- Primary completion10 May 2014
- Study completion10 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Losina, Brigham and Women's Hospital
- Investigators
- Elena Losina, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540851
- Sponsor's protocol ID
- 2010p002597
- Acronym
- AViKA
- Status last verified
- Jan 2018
- First submitted
- 21 Feb 2012
- Last updated
- 9 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Losina E, Collins JE, Daigle ME, Donnell-Fink LA, Prokopetz JJ, Strnad D, Lerner V, Rome BN, Ghazinouri R, Skoniecki DJ, Katz JN, Wright J. The AViKA (Adding Value in Knee Arthroplasty) postoperative care navigation trial: rationale and design features. BMC Musculoskelet Disord. 2013 Oct 12;14:290. doi: 10.1186/1471-2474-14-290.
PubMed 24119081Losina E, Collins JE, Wright J, Daigle ME, Donnell-Fink LA, Strnad D, Usiskin IM, Yang HY, Lerner V, Katz JN. Postoperative Care Navigation for Total Knee Arthroplasty Patients: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2016 Sep;68(9):1252-9. doi: 10.1002/acr.22829. Epub 2016 Jul 28.
PubMed 26714179
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adding Value in Knee Arthroplasty Post TKR Care Navigator Trial
- ClinicalTrials.gov ID
- NCT01540851
- Acronym / sponsor ID
- AViKA / 2010p002597
- Conditions
- Osteoarthritis, Degenerative Joint Disease
- Keywords
- Osteoarthritis, Total Knee Replacement, total Knee Arthroplasty, Post operative recovery, TKA, Post-operative recovery TKR, Care Navigator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 24 Jul 2011 (actual)
- Primary completion
- 10 May 2014 (actual)
- Study completion
- 10 May 2014 (actual)
- First posted
- 29 Feb 2012 (estimated)
- Results
- Posted 19 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this research are to:
Conduct a proof of concept randomized controlled trial with up to 300 patients undergoing primary total knee replacement (TKA) at Brigham and Women's Hospital (BWH). The trial will compare a "Care Navigator" post-discharge intervention versus "Usual Care" post discharge management of patients undergoing TKA. The intervention will focus on the challenging process of transitions from the acute care hospital to inpatient or outpatient rehabilitation, and from inpatient rehabilitation to home.
The principal goals of the trial are:
- To establish whether "Care Navigator" intervention improves functional outcomes as compared with the "Usual Care" treatment six months after TKA surgery.
- To establish whether "Care Navigator" intervention is cost effective six months after TKA surgery.
The investigators hypothesize that:
- Incorporating the Care Navigator role into the "Usual Care" treatment will increase TKA patients' rate of adherence to the rehabilitation protocol and improve functional outcomes.
- Addition of a Care Navigator is cost-effective.
Detailed description
The "Post-TKA Care Navigator" proof of concept intervention will be implemented as a randomized controlled trial. The investigators aim to identify and enroll a cohort of up to 300 subjects who have decided to undergo total knee replacement (TKA) at BWH. Subjects will be patients of the five orthopedic surgeons at Brigham and Women's Hospital who perform the most TKAs: Drs. Wright, Brick, Ready, Martin and Thornhill. Subjects will be followed from about two weeks prior to the operation to six months after discharge.
The investigators will assign patients into two groups, at random: 1) receiving current standard of post-operative care and 2) adding "Post-TKA Care Navigator". The role of the Care Navigator will be to follow up with patients via frequent telephone conversations, ranging from weekly during the first month to bi-weekly for the next 6 weeks to monthly by the 14th week post op. subjects assigned to the care navigator will receive up to 10 telephone calls over a period of 5 months. The goal of the Care Navigator would be to ensure or encourage compliance with physical therapy, triage patient concerns, questions and complaints, and identify those patients that require a call from a clinician to address a problem in the recovery process. For those issues that can be resolved easily at home the navigator would suggest strategies. The value of the post-TKA Care Navigator will be assessed by comparing functional status, satisfaction with surgery, utilization of health care, adherence to physical therapy, range of knee motion and intervention costs across the two randomized groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care Navigator Intervention Group | Active comparator | Behavioral: Care NavigatorSubjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively |
| Usual Care Group | Active comparator | Other: Standard Post-Operative TKA CareSubjects in the Usual Care group receive the current standard post-operative TKA care |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled to undergo primary TKA at Brigham \& Women's Hospital
- Osteoarthritis is the principal underlying diagnosis
- Age >=40 at the projected date of TKA
- English-speaking
Key exclusion criteria (9 listed)
- Osteoarthritis is not the principal underlying diagnosis (e.g. inflammatory arthritis)
- Dementia
- Psychological issues that preclude participation, as identified by participating surgeons
- Non-English speaker
- Diagnosis other than Osteoarthritis or secondary Osteoarthritis
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 |
|---|---|---|
| Care NavigatorSubjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharge from the hospital for 5 months after their total knee replacement. | Behavioural | Care Navigator Intervention Group |
| Standard Post-Operative TKA CareSubjects assigned to the Standard Post-Operative TKA Care group will receive the current standard of care for post-operative care | Other | Usual Care Group |
Primary outcome
Change in WOMAC Physical Function
Time frame: Change in functional status from baseline to 6 months
The change in functional status will be measured using the WOMAC Physical Function scale at Baseline and 6 months
2 secondary outcomes
Satisfaction
Time frame: Measured at 6 months post TKA
Range of Motion
Time frame: 6 months after TKA
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24119081Losina E, Collins JE, Daigle ME, Donnell-Fink LA, Prokopetz JJ, Strnad D, Lerner V, Rome BN, Ghazinouri R, Skoniecki DJ, Katz JN, Wright J. The AViKA (Adding Value in Knee Arthroplasty) postoperative care navigation trial: rationale and design features. BMC Musculoskelet Disord. 2013 Oct 12;14:290. doi: 10.1186/1471-2474-14-290.
- Results publication: PubMed 26714179Losina E, Collins JE, Wright J, Daigle ME, Donnell-Fink LA, Strnad D, Usiskin IM, Yang HY, Lerner V, Katz JN. Postoperative Care Navigation for Total Knee Arthroplasty Patients: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2016 Sep;68(9):1252-9. doi: 10.1002/acr.22829. Epub 2016 Jul 28.
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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.
Elena Losina, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Navigator and Standard Post-Operative TKA Care in people with Osteoarthritis and Degenerative Joint Disease, run by Brigham and Women's Hospital at 1 site 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 4 inclusion and 9 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 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 19 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in WOMAC Physical Function (time frame: Change in functional status from baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01540851, which also lists 2 linked publications.
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 9 Feb 2018; AzTrials last refreshed its copy on 27 Oct 2026.