Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Adding Value in Knee Arthroplasty Post-total Knee Replacement (TKR) Care Navigator Trial (AViKA)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Elena Losina, Brigham and Women's Hospital Identifier:
First received: February 21, 2012
Last updated: January 30, 2015
Last verified: January 2015

February 21, 2012
January 30, 2015
July 2011
May 2014   (final data collection date for primary outcome measure)
Functional Status [ Time Frame: Change in baseline function at 6 months ] [ Designated as safety issue: No ]
Functional status will be measured using the WOMAC scale at Baseline, 3 and 6 months
Same as current
Complete list of historical versions of study NCT01540851 on Archive Site
  • Satisfaction and cost effectiveness [ Time Frame: Measured at 3 & 6 months post TKA ] [ Designated as safety issue: No ]
  • Range of Motion [ Time Frame: Baseline, 3 and 6 months after TKA ] [ Designated as safety issue: No ]
    Range of Motion will be documented on the baseline and 6 month musculoskeletal exam and baseline, 3 month and 6 month questionnaires (self reported)
Same as current
Not Provided
Not Provided
Adding Value in Knee Arthroplasty Post-total Knee Replacement (TKR) Care Navigator Trial
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.

The principal goals of the trial are:

  1. To establish whether "Care Navigator" intervention improves functional outcomes as compared with the "Usual Care" treatment six months after TKA surgery.
  2. To establish whether "Care Navigator" intervention is cost effective six months after TKA surgery.

The investigators hypothesize that:

  1. 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.
  2. Addition of a Care Navigator is cost-effective.

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.

Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Osteoarthritis
  • Degenerative Joint Disease
Behavioral: Care Navigator

Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.

Subjects assigned to the usual Care group will receive current standard of post-operative care

  • Active Comparator: Care Navigator Intervention Group
    Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively
    Intervention: Behavioral: Care Navigator
  • Active Comparator: Usual Care Group
    Subjects in the Usual Care group receive the current standard post-operative TKA care
    Intervention: Behavioral: Care Navigator
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
November 2018
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
40 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
Elena Losina, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
Principal Investigator: Elena Losina, PhD Brigham and Women's Hospital
Brigham and Women's Hospital
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP