Physical Resilience: Indicators and Mechanisms in the Elderly (PRIME) Collaborative Phase 2 (PRIME-Knee)

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).

Study Overview

• Status: Completed
• Conditions: Aging; Resilience

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 297

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Durham, North Carolina, United States, 27710
      • Duke University Hospital
    • Durham, North Carolina, United States, 27704
      • Duke Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Prospective observational study of n=250 adults aged 60 years and older undergoing elective total knee replacements with 6 months of follow-up.

Description

Inclusion Criteria:

• 60 years of age or older
• Ability to speak English
• Planned elective knee replacement orthopedic surgery lasting 2 or more hours and requiring overnight observation or inpatient stay
• Community dwelling

Exclusion Criteria:

• Unable to ambulate independently, with or without assistive device
• Known dementia or screening 3MS score <=77
• Inmate of a correctional facility (i.e. prisoners)
• Active non-skin cancer or medical treatment for non-skin cancer with 12 months (chemotherapy, radiation, immunotherapy, hormonal therapy)
• Vision or hearing impairment that, after best accommodation, prevents reliable cognitive assessment (visual/hearing) and/or precludes telephone interviews (hearing)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Total Knee Replacement Cohort; Any patients who are scheduled to undergo a total knee replacement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Cathleen S Colon-Emeric, MD, MHS, Duke University; Principal Investigator: Heather E Whitson, MD, MHS, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2020
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: January 17, 2020
• First Submitted That Met QC Criteria: January 17, 2020
• First Posted (Actual): January 21, 2020

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Pro00103483; 4UH3AG056925-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No