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| ID | Type | Description | Link |
|---|---|---|---|
| 4UH3AG056925-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The purpose of this study is to examine underlying physical resilience (the ability to bounce back) in response to a specific stressor (total knee replacement).
In general, a person's specific resilience (ability to bounce back from a stressor) is thought to be dependent upon that person's specific biological and genetic makeup. However, these specific elements remain poorly understood. The purpose of this study is to identify important predictors and characteristics of resilience in response to a total knee replacement by examining baseline resilience (prior to surgery) and post-surgical resilience at multiple time points, allowing us to track resilience outcomes over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total Knee Replacement Cohort | Any patients who are scheduled to undergo a total knee replacement. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in musculoskeletal resiliency following orthopedic surgery as measured by physical activity (step counts) | As measured by a Garmin device worn by participants | Baseline, 1 week, 1 month, 2 months, 4 months and 6 months |
| Change in musculoskeletal resiliency following orthopedic surgery as measured by Lower Extremity Physical Activities of Daily Living (LE PADLs) | Scores are measured from 0 to 45. Higher scores are associated with more limited LE PADLs. | Baseline, 6 months |
| Change in musculoskeletal resiliency following orthopedic surgery as measured by PROMIS Pain Intensity | Scores are measured from 3 to 15. Higher scores are associated with more intense pain. | Baseline, 1 week, 1 month, 2 months, 4 months and 6 months |
| Change in musculoskeletal resiliency following orthopedic surgery as measured by PROMIS Pain Interference | Scores are measured from 6 to 30. Higher scores are associated with increased pain interference. | Baseline, 1 week, 1 month, 2 months, 4 months and 6 months |
| Change in cognitive resiliency following orthopedic surgery as measured by 3D-CAM. | Scored as positive or negative. Positive indicates the presence of delirium. | Baseline, 1 week |
| Change in cognitive resiliency following orthopedic surgery as measured by cognitive change index (CCI) for patient. | Scores range from 20 - 100. Higher scores are associated with increased cognitive decline. | Baseline, 1 month, 2 months, 4 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in dual task gait speed | Score of combined walking and verbal fluency test | Baseline, 6 months |
| Change in tissue oxygenation index (TOI) | Measured using fNIRs (functional near infrared spectroscopy) |
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Inclusion Criteria:
Exclusion Criteria:
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Prospective observational study of n=250 adults aged 60 years and older undergoing elective total knee replacements with 6 months of follow-up.
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| Name | Affiliation | Role |
|---|---|---|
| Cathleen S Colon-Emeric, MD, MHS | Duke University | Principal Investigator |
| Heather E Whitson, MD, MHS | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Regional Hospital | Durham | North Carolina | 27704 | United States | ||
| Duke University Hospital |
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Blood samples will be collected from study participants at the baseline visit (before surgery) and 24 hours after surgery.
| Change in cognitive resiliency following orthopedic surgery as measured by cognitive change index (CCI) for informant about patient. | Scores range from 20 - 100. Higher scores are associated with increased cognitive decline. | Baseline, 1 month, 2 months, 4 months, 6 months |
| Change in association between in vitro immune resiliency and resilient outcomes following elective orthopedic surgery. | Whole blood samples containing PBMCs collected before/after surgery will be challenged with LPS and influenza vaccine to assess the cellular immune response using previously identified biomarkers of resiliency and RNA-seq analysis to identify novel biomarkers and molecular signatures. | Baseline, Post-operative Day 1 |
| Baseline, 6 months |
| Intraoperative electrocardiography (ECG) RR variability | Measured as intra-operative ECG RR intervals collected from the heart monitor | Surgery up to three hours |
| Durham |
| North Carolina |
| 27710 |
| United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |