Functional Predictive Value of Collective Outcome Measure(s) Status Post Total Hip/Knee Arthroplasty

Researchers are trying to assess a predictive value or correlation of outcome measures results on subjects following a total knee or total hip arthroplasty in order to better predict the time frame taken to achieve certain functional milestones that are pertinent to subject population.

Study Overview

• Status: Completed
• Conditions: Joint Arthroplasty; Knee and Hip

Detailed Description

Subjects will undergo testing for a normal physical therapy clinical assessment that is standard of care for anyone who has a total hip or total knee surgery. Researchers will be using the data obtained from standard therapy care and see if correlations exist from that data and the time taken to complete specific functional tasks.

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects status post total hip and total knee arthroplasty that will undergo standard inpatient and outpatient physical therapy evaluation following total joint surgery.

Description

Inclusion Criteria:

• Patient's 18 years or older
• Patients who recently underwent a primary total hip or total knee arthroplasty
• Patient who recently underwent a total hip or total knee revision

Exclusion Criteria:

• Patients who lack the ability to provide informed consent
• Patients with previous total joint replacement within the last 6 months
• Patients with complications following surgery such as DVT/PE/Infection

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assistive Device Weaning	Number of days to weaning from all assistive devices	Approximately 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weaning from pain medication, ability to reciprocally use steps, ability to walk 1 mile or 30 minutes consecutively	Number of days taken to achieve milestones	Approximately 3-6 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Ryan C McCoy, PT, DPT, OCS, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2019
• Primary Completion (Actual): December 23, 2022
• Study Completion (Actual): December 23, 2022

Study Registration Dates

• First Submitted: April 30, 2019
• First Submitted That Met QC Criteria: April 30, 2019
• First Posted (Actual): May 1, 2019

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 18-009437

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