Knee Replacement Rehabilitation Care Pathways

NCT07598539 | Not Yet Recruiting

• 1 other identifier: K23MD018640
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

Brief Summary

Previous research has shown that use of rehabilitation (including physical therapy) and the recovery of function after knee replacement surgery may differ depending on patients' race, sex, income or insurance, and geographic location. In this study, the investigators will develop and test a new care pathway for knee replacement rehabilitation that is designed to maximize functional recovery for all patients and reduce differences between different groups of patients. Findings from this project will lead to improved rehabilitation quality after knee replacement surgery.

Conditions

Knee Replacement, Total

Keywords

knee replacement; knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction

  A patient satisfaction survey will be collected at 3 months post-operative, to query all patients' satisfaction with pre-operative education, ease of scheduling of post-TKA rehabilitation, and perceptions of the overall post-TKA rehab pathway. A modified version of the PSQ-III patient satisfaction survey will be used, in which each construct is rated by the patient on a 1-5 scale, with higher scores indicating greater satisfaction with care.

  3 months post-TKA surgery

Secondary Outcomes (3)

• Rehab timing

  For most patients, this will occur approximately 2 weeks post-operatively.

• Completion of in-depth, semi-structured focus group interviews (study participants)

  3 months post-operatively

• Completion of in-depth, semi-structured 1-on-1 interviews (physical therapists who treat patients post-total knee arthroplasty)

  4 months after enrollment of the first participant in the study

Study Arms (2)

Control - Usual Rehab

ACTIVE COMPARATOR

Participants in the 'control' practice will receive post-TKA rehabilitation according to the current usual pathway. This typically involves discharge to home on post-operative day 0 or 1, followed by 5 visits of home health physical therapy, followed by outpatient physical therapy at a frequency and duration deemed appropriate by the care team.

Behavioral: Usual Rehab

Intervention - Optimized Rehab

EXPERIMENTAL

Participants receiving TKA in the 'intervention' practice will be guided by clinical staff to follow the new "optimized" pathway. The progression from inpatient to home health to outpatient physical therapy will remain the same, but with the addition of the interventions described below.

Behavioral: TKA Journey - patient education; Other: Optimized Rehab Scheduling

Interventions

TKA Journey - patient education BEHAVIORAL

The investigators' team developed a new patient education booklet containing information that walks the patient through their TKA journey, from pre-operative to hospital-based rehabilitation prior to discharge, to outpatient physical therapy, and after discharge from formal physical therapy services. All patients in the intervention arm will receive this booklet from their surgeon's office and will receive a phone call from study personnel to review it and answer any questions.

Intervention - Optimized Rehab

Optimized Rehab Scheduling OTHER

For all patients in the 'intervention' practice, the home health referral will include instructions for the home health physical therapist to assist the patient with scheduling their first outpatient physical therapy session, to avoid unnecessary gaps in care between home health discharge and outpatient physical therapy evaluation.

Intervention - Optimized Rehab

Usual Rehab BEHAVIORAL

Participants in the usual rehab group will continue to follow the current standard-of-care rehabilitation pathway for patients post-TKA.

Control - Usual Rehab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• scheduled to receive unilateral TKA surgery at a University of Pittsburgh Medical Center hospital
• plans to utilize UPMC Home Health and/or UPMC Rehab Institute for home health and/or outpatient rehabilitation post-operatively

You may not qualify if:

• does not undergo planned surgery
• does not receive any post-TKA rehabilitation at UPMC facilities

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

Location

Study Officials

• Allyn M Bove, DPT, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allyn M Bove, DPT, PhD

CONTACT

412-624-9255; allyn.bove@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The new care pathways will be implemented from the practice level and downward, meaning that all patients receiving TKA from the "intervention" surgical practice within the three-month study period will be guided by surgical and rehabilitation staff to follow the new pathways. In the 'control' practice, the investigators will simply obtain information regarding patients' rehabilitation utilization and functional outcomes during the 3-month study period from an institutional data warehouse. The 'control' practice is located in a similarly-sized hospital less than 2 miles from the 'intervention" practice, and internal data indicate that patient demographics are very similar between the two.

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be made available no later than when the relevant manuscript is published, or at the end of the study's award period, whichever comes first.
• Access Criteria: Access: Researchers who request access to the IPD and sign a data use agreement will be granted access to the IPD and supporting information. Information available: De-identified IPD will be available in SAS or Excel format. The investigators will also make the analytical codes used to process and analyze quantitative data available to other researchers upon request. Mode: Data files will be shared using a secure, cloud-based service. The School of Health and Rehabilitation Sciences Data Center at the principal investigator's institution will assist with ensuring the security of the data to be shared and placing the files in a secure cloud-based location for the requesting researcher to access. For more details: A copy of the full data sharing plan that was submitted to the study funder is available by contacting the principal investigator by email or postal mail.

Locations

US (1)