NCT01540851: AViKA

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

Completed NA Results posted Last updated 9 February 2018

What this trial tests

NA trial testing Care Navigator in Osteoarthritis in 308 participants. Completed in 10 May 2014.

Timeline

24 July 2011

Primary endpoint
10 May 2014

10 May 2014

Quick facts

Lead sponsor	Brigham and Women's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	308
Start date	24 July 2011
Primary completion	10 May 2014
Estimated completion	10 May 2014
Sites	1 location across United States

Drugs / interventions tested

• Care Navigator
• Standard Post-Operative TKA Care

Conditions studied

• Osteoarthritis — all drugs for Osteoarthritis →
• Degenerative Joint Disease — all drugs for Degenerative Joint Disease →

Sponsor

Brigham and Women's Hospital

Who can join

40 and older, any sex, with Osteoarthritis or Degenerative Joint Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in WOMAC Physical Function Primary · 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

Group	Value	95% CI
Care Navigator Intervention Group	-30	-33 – -27
Usual Care Group	-27	-30 – -23

Satisfaction Secondary · Measured at 6 months post TKA

Percentage of patients in each study arm who reported being very satisfied with the results of TKA

Group	Value	95% CI
Care Navigator Intervention Group	80
Usual Care Group	72

Range of Motion Secondary · 6 months after TKA

Percentage of participants able to bend knee at least 120 degrees

Group	Value	95% CI
Care Navigator Intervention Group	70
Usual Care Group	72

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Care Navigator Intervention Group

Serious: 0/154 (0%)

Deaths: —

Usual Care Group

Serious: 1/154 (1%)

Deaths: —

Serious adverse events (1 terms)

Reaction	System	Care Navigator Interventio…	Usual Care Group
Death	General disorders	—	—

Most-reported serious reactions: Death.

Data from ClinicalTrials.gov NCT01540851 adverse events section.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Association between socioeconomic status and pain, function and pain catastrophizing at presentation for total knee arthroplasty.
   Feldman CH, Dong Y, Katz JN, Donnell-Fink LA, et al · · 2015 · cited 84× · PMID 25768862 · DOI 10.1186/s12891-015-0475-8
2. Postoperative Care Navigation for Total Knee Arthroplasty Patients: A Randomized Controlled Trial.
   Losina E, Collins JE, Wright J, Daigle ME, et al · · 2016 · cited 23× · PMID 26714179 · DOI 10.1002/acr.22829
3. The AViKA (Adding Value in Knee Arthroplasty) postoperative care navigation trial: rationale and design features.
   Losina E, Collins JE, Daigle ME, Donnell-Fink LA, et al · · 2013 · cited 10× · PMID 24119081 · DOI 10.1186/1471-2474-14-290
4. Impact of Preoperative and Incident Musculoskeletal Problematic Areas on Postoperative Outcomes After Total Knee Replacement.
   Zhang M, Selzer F, Losina E, Collins JE, et al · · 2021 · cited 2× · PMID 34323387 · DOI 10.1002/acr2.11241
5. Musculoskeletal Symptomatic Areas After Total Knee Replacement for Osteoarthritis.
   Zhang M, Selzer F, Losina E, Collins JE, et al · · 2019 · cited 1× · PMID 31777817 · DOI 10.1002/acr2.11055