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

Completed · Not applicable

Conditions studied: Osteoarthritis, Degenerative Joint Disease

In brief

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.

Key facts

Study ID

NCT01540851

Run by

Brigham and Women's Hospital

People needed

308

Starts

2011-07-24

Expected to finish

2014-05-10

Last updated by the study team

2018-02-09

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Brigham & Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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