Knee Replacement, TotalNCT07598539
Knee Replacement Rehabilitation Care Pathways
A study testing TKA Journey - patient education, Optimized Rehab Scheduling and Usual Rehab in people with Knee Replacement, Total, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Replacement, Total
- What is being tested?
- TKA Journey - patient education, Optimized Rehab Scheduling and Usual Rehab
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- does not undergo planned surgery
- does not receive any post-TKA rehabilitation at UPMC facilities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15219
Allyn M Bove, DPT, PhD, 412-624-9255, allyn.bove@pitt.edu
About this study
Official title: Development and Implementation of Optimal Rehabilitation Care Pathways to Reduce Disparities in Rehabilitation Outcomes After Joint Replacement
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.
Read the detailed description
In previous work, the investigators used quantitative and qualitative data to identify sociodemographic disparities in physical function and use of rehabilitation following total knee arthroplasty (TKA), or knee replacement surgery. The investigators also identified patient and provider impressions regarding areas of the post-TKA rehabilitation pathway and recommendations for improvements. Based on all of this information, the investigative team has developed a newly-optimized rehabilitation care pathway and will pilot test this approach in this study.
- Conditions
- Knee Replacement, Total
- Being tested
- TKA Journey - patient education, Optimized Rehab Scheduling, Usual Rehab, Physical Therapist reminders
- Keywords
- knee replacement, knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TKA Journey - patient educationBehavioural
The investigators' team are co-developing new patient education materials with patients and physical therapists, to be presented at the pre-operative "total joint class" that patients awaiting knee and hip replacement attend prior to their surgery. These new materials replace previous slides that were presented about rehabilitation post-knee replacement.
Optimized Rehab SchedulingOther
For all patients in the 'intervention' cohort, the home health physical therapist will receive instruction 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.
Usual RehabBehavioural
Participants in the usual rehab group will continue to follow the current standard-of-care rehabilitation pathway for patients post-TKA.
Physical Therapist remindersBehavioural
Along with implementation of the new patient education materials, outpatient physical therapists will receive reminder materials regarding the preferred elements of the current standard-of-care "prehabilitation" visit --- a single outpatient physical therapy visit that patients awaiting total knee replacement are instructed to attend prior to their surgery. Instructions exist regarding the content of these visits, but physical therapists in the system have not received updated materials or reminders regarding the content of the visits in quite some time. This will serve as a reminder of "best practices" and re-education to the prehabilitation process.
| Study group | Role | What they receive |
|---|---|---|
| Control - Usual Rehab | Active comparator | We will gather data on patients to form a historical control group (those whose knee replacement surgery and rehab was completed prior to implementation of the new rehab pathway). This pathway 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. Receives: Behavioral: Usual Rehab |
| Intervention - Optimized Rehab | Experimental | We will form the interventional cohort by gathering data on patients whose knee replacement surgery and rehab occur after implementation of the new 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. Receives: Behavioral: TKA Journey - patient education; Other: Optimized Rehab Scheduling; Behavioral: Physical Therapist reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post-TKA surgery
Secondary outcomes (2)
Patient focus groups to assess implementation outcomes
The investigators will conduct focus groups with patients who followed the optimized post-TKA rehab pathway to learn in-depth about their impressions of the pathway. The focus group guide will include questions about patient perception of their post-TKA rehab, transitions between home health and outpatient physical therapy, the completeness of educational information they received from their surgical care team and physical therapists, and any difficulties they may have encountered during any phase of post-TKA rehabilitation. These focus groups will be recorded, transcribed verbatim, and then coded by two independent trained coders using a codebook created iteratively by the coders and the investigators. Themes will be identified and summarized by the investigators.
Measured: Upon completion of all rehab post-total knee replacement (approximately 3 months post-operatively)
Completion of in-depth, semi-structured 1-on-1 interviews (physical therapists who treat patients post-total knee arthroplasty)
The investigators will conduct 1-on-1 semi-structured interviews to assess home health and outpatient physical therapist perceptions of the optimized post-TKA rehab pathway. The interview guide will include questions about physical therapist perception of the optimized post-TKA rehabilitation pathway, transitions between home health and outpatient physical therapy, the completeness of educational information patients received from their surgical care team and physical therapists, and any difficulties they may have experienced while implementing the new optimized care pathway. These interviews will be recorded, transcribed verbatim, and then coded by two independent trained coders using a codebook created iteratively by the coders and the investigators. Themes will be identified and summarized by the investigators.
Measured: 4 months after enrollment of the first participant in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 Oct 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Replacement, TotalStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- In the first phase of this study, a human-centered design approach will be employed to invite physical therapists and patients who have recently undergone knee replacement surgery to co-design updated educational materials to be presented in UPMC's pre-operative joint replacement classes. These newly-updated materials will be combined with reminders/updates to Home Health and Outpatient physical therapists regarding "best practices" with scheduling rehab of patients with knee replacement and contents of current standard-of-care "prehabilitation" sessions that are held prior to surgery. Implementation of all of these will be timed to coincide with implementation of a new electronic health record system that will solve current challenges in which acute care, home health, and outpatient physical therapists cannot view each other's patient notes. All of these elements together will be considered the new post-total knee rehab pathway.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Allyn Bove, University of Pittsburgh
- Investigators
- Allyn M Bove, DPT, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598539
- Sponsor's protocol ID
- STUDY26080050
- Other IDs
- K23MD018640
- Status last verified
- Oct 2026
- First submitted
- 8 May 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Any requests for data sharing should be directed to the Principal Investigator by e-mail or postal mail. The identity of human subjects will be protected. Data that is shared will be stripped of any remaining patient identifiers including the date that subjects were entered into the study. Original data elements that contain protected health information will not be shared, but relevant transformed or computed variables will be available. Investigators requesting data will be required to sign a data sharing agreement. The Principal Investigator will be available by e-mail, telephone, or written correspondence to assist other investigators in the use of the data. Data will be made available no later than when a relevant manuscript is published. Data will be made available in SAS or Excel format. Investigators will make the analytical codes used to process and analyze quantitative data available to other researchers. Data files will be shared using a secure cloud-based service.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Implementation of Optimal Rehabilitation Care Pathways to Reduce Disparities in Rehabilitation Outcomes After Joint Replacement
- ClinicalTrials.gov ID
- NCT07598539
- Acronym / sponsor ID
- STUDY26080050
- Conditions
- Knee Replacement, Total
- Keywords
- knee replacement, knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In previous work, the investigators used quantitative and qualitative data to identify sociodemographic disparities in physical function and use of rehabilitation following total knee arthroplasty (TKA), or knee replacement surgery. The investigators also identified patient and provider impressions regarding areas of the post-TKA rehabilitation pathway and recommendations for improvements. Based on all of this information, the investigative team has developed a newly-optimized rehabilitation care pathway and will pilot test this approach in this study.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In the first phase of this study, a human-centered design approach will be employed to invite physical therapists and patients who have recently undergone knee replacement surgery to co-design updated educational materials to be presented in UPMC's pre-operative joint replacement classes. These newly-updated materials will be combined with reminders/updates to Home Health and Outpatient physical therapists regarding "best practices" with scheduling rehab of patients with knee replacement and contents of current standard-of-care "prehabilitation" sessions that are held prior to surgery. Implementation of all of these will be timed to coincide with implementation of a new electronic health record system that will solve current challenges in which acute care, home health, and outpatient physical therapists cannot view each other's patient notes. All of these elements together will be considered the new post-total knee rehab pathway.
| Arm | Type | Receives |
|---|---|---|
| Control - Usual Rehab | Active comparator | Behavioral: Usual RehabWe will gather data on patients to form a historical control group (those whose knee replacement surgery and rehab was completed prior to implementation of the new rehab pathway). This pathway 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. |
| Intervention - Optimized Rehab | Experimental | Behavioral: TKA Journey - patient education, Other: Optimized Rehab Scheduling, Behavioral: Physical Therapist remindersWe will form the interventional cohort by gathering data on patients whose knee replacement surgery and rehab occur after implementation of the new 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- does not undergo planned surgery
- does not receive any post-TKA rehabilitation at UPMC facilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TKA Journey - patient educationThe investigators' team are co-developing new patient education materials with patients and physical therapists, to be presented at the pre-operative "total joint class" that patients awaiting knee and hip replacement attend prior to their surgery. These new materials replace previous slides that were presented about rehabilitation post-knee replacement. | Behavioural | Intervention - Optimized Rehab |
| Optimized Rehab SchedulingFor all patients in the 'intervention' cohort, the home health physical therapist will receive instruction 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. | Other | Intervention - Optimized Rehab |
| Usual RehabParticipants in the usual rehab group will continue to follow the current standard-of-care rehabilitation pathway for patients post-TKA. | Behavioural | Control - Usual Rehab |
| Physical Therapist remindersAlong with implementation of the new patient education materials, outpatient physical therapists will receive reminder materials regarding the preferred elements of the current standard-of-care "prehabilitation" visit --- a single outpatient physical therapy visit that patients awaiting total knee replacement are instructed to attend prior to their surgery. Instructions exist regarding the content of these visits, but physical therapists in the system have not received updated materials or reminders regarding the content of the visits in quite some time. This will serve as a reminder of "best practices" and re-education to the prehabilitation process. | Behavioural | Intervention - Optimized Rehab |
Primary outcome
Patient Satisfaction
Time frame: 3 months post-TKA surgery
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.
2 secondary outcomes
Patient focus groups to assess implementation outcomes
Time frame: Upon completion of all rehab post-total knee replacement (approximately 3 months post-operatively)
Completion of in-depth, semi-structured 1-on-1 interviews (physical therapists who treat patients post-total knee arthroplasty)
Time frame: 4 months after enrollment of the first participant in the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. Any requests for data sharing should be directed to the Principal Investigator by e-mail or postal mail. The identity of human subjects will be protected. Data that is shared will be stripped of any remaining patient identifiers including the date that subjects were entered into the study. Original data elements that contain protected health information will not be shared, but relevant transformed or computed variables will be available. Investigators requesting data will be required to sign a data sharing agreement. The Principal Investigator will be available by e-mail, telephone, or written correspondence to assist other investigators in the use of the data. Data will be made available no later than when a relevant manuscript is published. Data will be made available in SAS or Excel format. Investigators will make the analytical codes used to process and analyze quantitative data available to other researchers. Data files will be shared using a secure cloud-based service.
Related trials for Knee Replacement, Total
Active, not recruiting
Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
Pain
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
RecruitingPhase 2/3
Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty
Prosthetic-joint Infection
Not yet recruitingObservational study
Agreement Between Patient-Reported Pain, Observer-Rated Pain Behavior, and Analgesic Request After Total Knee Arthroplasty
Postoperative Pain After Total Knee Arthroplasty
Enrolling by invitationObservational study
Smartphone Video-Based AI Gait Analysis Reports to Support Remote Follow-up After Total Knee Arthroplasty
Total Knee Arthroplasty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Allyn M Bove, DPT, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TKA Journey - patient education, Optimized Rehab Scheduling and Usual Rehab in people with Knee Replacement, Total, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allyn M Bove, DPT, PhD (412-624-9255, allyn.bove@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: 3 months post-TKA surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.