N/A
Completed N=308
Adding Value in Knee Arthroplasty Post-total Knee Replacement (TKR) Care Navigator Trial
Osteoarthritis · Degenerative Joint Disease
Source: ClinicalTrials.gov NCT01540851 ↗
Enrolled (actual)
308
Serious AEs
0.3%
Results posted
Feb 2016
Primary outcomePrimary: Change in WOMAC Physical Function — -30; -27 units on a scale
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). 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in WOMAC Physical Function |
-30; -27 | — |
| SECONDARY Satisfaction |
80; 72 | — |
| SECONDARY Range of Motion |
70; 72 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01540851). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.