Arthritis KneeNCT06821269
Functional Recovery After Total Knee Arthroplasty
An observational study of Arthritis Knee, run by University of Pittsburgh at 1 site in United States.
Trial summary
The goal of this observational study is to learn about patients' recoveries after receiving total knee arthroplasty (TKA). The main questions it aims to answer are: Does robotic-assisted TKA have improved perceived recovery when compared to conventional TKA? Does robotic-assisted TKA lead to improved functional… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Arthritis Knee
- What is being tested?
- Robotic assisted total knee arthroplasty, Manual total knee arthroplasty and Robotic assisted revision total knee arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 1 May 2027
- Phase
- Observational
- 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 40 to 90 years
- All sexes
- Adult, Older adult
Study population: The study population consists of patients who are candidates for primary or revision total knee arthroplasty.
Who may be able to join
- Candidate for TKA
- Speak English / understand study instructions--this is necessary to reliably complete the study questionnaires and understand study instructions which are not validated in other languages
- Have medical clearance from PCP, PI, or co-Investigator to participate in the study
- Willing to comply with all study procedures and be available for the duration of the study
Who cannot join
- 2+ falls in the past year
- Unable to ambulate 100 ft without assistive device or rest period
- Acute illness
- Have a history of cardiovascular disease or hypertension not controlled by medication
- Severe visual impairment
- Lower-extremity amputation
Show all 11Show fewer
- Neurological, muscular, systemic, or connective tissue disorder affecting the function of the lower extremities
- Pregnant
- Terminal illness
- Plans to have another joint replacement during study period
- Plans to relocate from immediate area during study period
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
The goal of this observational study is to learn about patients' recoveries after receiving total knee arthroplasty (TKA). The main questions it aims to answer are:
Does robotic-assisted TKA have improved perceived recovery when compared to conventional TKA? Does robotic-assisted TKA lead to improved functional recovery when compared to conventional TKA?
Researchers will compare if robotic-assisted versus conventional procedures lead to different recovery speeds.
Participants will answer questionnaires and undergo physical therapy testing before and at several timepoints after their procedure.
Read the detailed description
The choice to perform robotic assisted vs manual total knee arthroplasties (TKA) depends on many factors, including but not limited to surgeon training, resource availability, and patient-specific considerations. Recent studies comparing patient outcomes after robotic-assisted and manual total knee arthroplasties have shown mixed results. These studies often focus on future complication rates, radiographic outcomes, or patient reported outcomes between manual and robotic-assisted TKA. Hence, there has been little focus on improvements in functional outcomes after TKA. Combining functional test results, patient reported outcomes, kinematic studies, and data from wearable devices will allow for a comprehensive timeline of recovery speed after either robotic-assisted or manual TKA.
The overall aim of this proposed study is to quantify functional and PROM at specific timepoints in patients after robotic-assisted or manual total knee arthroplasty (TKA).
The questions are:
- Do robotic-assisted revision TKAs have improved functional and perceived recovery when compared to manual revision TKAs?
- Do robotic-assisted primary TKAs have improved functional and perceived recovery when compared to manual primary TKAs?
- Do robotic-assisted revision TKAs have similar functional and perceived recovery as robotic-assisted primary TKAs?
For questions 1 and 2, we hypothesize that robotic-assisted revision or primary TKAs will have improved recovery when compared to manual TKAs.
For question 3, we hypothesize that robotic-assisted revision TKA will have similar recovery to primary robotic-assisted TKA.
Patients who are candidates for revision or primary TKA will be recruited within the Department of Orthopaedic Surgery. All subjects will participate in 6 evaluation sessions: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery. Testing sessions will be approximately 1 hour long and will take place at the Physical Therapy Clinical and Translational Research Center (PT-CTRC).
At the time of enrollment, subjects will sign the informed consent in the presence of a study investigator. The research coordinator will collect data on demographics, medical history, and biomedical information. Note: Subjects who do not sign the consent form cannot participate in the study.
At each evaluation, patients will then be given time to complete the following patient reported outcome questionnaires: Forgotten Joint, Promis 29, Koos, SF 36. The physical therapist will then lead the patient through a series of functional measurement tests: Timed Up and Go (TUG), 4m and 10m walking speed test, sit/stand, Star Excursion Balance Test (SEBT), 2-minute walk, stair climb test (SCT), Single Leg Stance (SLS), and Y Balance Test (YBT). Videos may be taken to record progress.
- Conditions
- Arthritis Knee
- Being tested
- Robotic assisted total knee arthroplasty, Manual total knee arthroplasty, Robotic assisted revision total knee arthroplasty, Manual revision total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic assisted total knee arthroplastyProcedure or surgery
Total knee arthroplasty with robotic assisatance
Manual total knee arthroplastyProcedure or surgery
Total knee arthroplasty without robotic assistance
Robotic assisted revision total knee arthroplastyProcedure or surgery
Revision total knee arthroplasty with robotic assistance
Manual revision total knee arthroplastyProcedure or surgery
Revision total knee arthroplasty without robotic assistance
| Study group | Role | What they receive |
|---|---|---|
| Manual Revision TKA | These patients underwent revision TKA done manually Receives: Procedure: Manual revision total knee arthroplasty | |
| Robotic-assisted Revision TKA | These patients underwent revision TKA with robotic-assistance Receives: Procedure: Robotic assisted revision total knee arthroplasty | |
| Manual Primary TKA | These patients received primary TKAs done manually Receives: Procedure: Manual total knee arthroplasty | |
| Robotic-assisted Primary TKA | These patients received primary TKAs with robotic-assistance Receives: Procedure: Robotic assisted total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go (TUG)
TUG requires the patient to sit in a chair, stand, walk to a line 3m away, turn, walk back to the chair, and sit again
Measured: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
4m and 10m Walking Speed Test
Measured: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
2-minute Walk
Measured: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
Stair Climb Test
Measured: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
Y Balance Test
The YBT requires the person to balance on one leg whilst simultaneously reaching as far as possible with the other leg in three separate directions: anterior, posterolateral, and posteromedial
Measured: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
Secondary outcomes (4)
Forgotten Joint Score
The Forgotten Joint Score (FJS) is a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint.
Measured: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
Promis
PROMIS stands for Patient Reported Outcomes Measurement Information System, which is a system of highly reliable, precise measures of patient-reported health status for physical, mental, and social well-being
Measured: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
SF36
The Short Form 36 Health Survey Questionnaire (SF-36) is used to indicate the health status of particular populations, to help with service planning and to measure the impact of clinical and social interventions.
Measured: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
KOOS
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that helps patients and therapists assess knee injury outcomes over time
Measured: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start1 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis KneeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Urish, University of Pittsburgh
- Investigators
- Kenneth Urish, MD PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821269
- Sponsor's protocol ID
- STUDY23060125
- Status last verified
- Aug 2026
- First submitted
- 6 Feb 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Recovery After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06821269
- Acronym / sponsor ID
- STUDY23060125
- Conditions
- Arthritis Knee
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 11 Feb 2025 (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.
The goal of this observational study is to learn about patients' recoveries after receiving total knee arthroplasty (TKA). The main questions it aims to answer are:
Does robotic-assisted TKA have improved perceived recovery when compared to conventional TKA? Does robotic-assisted TKA lead to improved functional recovery when compared to conventional TKA?
Researchers will compare if robotic-assisted versus conventional procedures lead to different recovery speeds.
Participants will answer questionnaires and undergo physical therapy testing before and at several timepoints after their procedure.
Detailed description
The choice to perform robotic assisted vs manual total knee arthroplasties (TKA) depends on many factors, including but not limited to surgeon training, resource availability, and patient-specific considerations. Recent studies comparing patient outcomes after robotic-assisted and manual total knee arthroplasties have shown mixed results. These studies often focus on future complication rates, radiographic outcomes, or patient reported outcomes between manual and robotic-assisted TKA. Hence, there has been little focus on improvements in functional outcomes after TKA. Combining functional test results, patient reported outcomes, kinematic studies, and data from wearable devices will allow for a comprehensive timeline of recovery speed after either robotic-assisted or manual TKA.
The overall aim of this proposed study is to quantify functional and PROM at specific timepoints in patients after robotic-assisted or manual total knee arthroplasty (TKA).
The questions are:
- Do robotic-assisted revision TKAs have improved functional and perceived recovery when compared to manual revision TKAs?
- Do robotic-assisted primary TKAs have improved functional and perceived recovery when compared to manual primary TKAs?
- Do robotic-assisted revision TKAs have similar functional and perceived recovery as robotic-assisted primary TKAs?
For questions 1 and 2, we hypothesize that robotic-assisted revision or primary TKAs will have improved recovery when compared to manual TKAs.
For question 3, we hypothesize that robotic-assisted revision TKA will have similar recovery to primary robotic-assisted TKA.
Patients who are candidates for revision or primary TKA will be recruited within the Department of Orthopaedic Surgery. All subjects will participate in 6 evaluation sessions: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery. Testing sessions will be approximately 1 hour long and will take place at the Physical Therapy Clinical and Translational Research Center (PT-CTRC).
At the time of enrollment, subjects will sign the informed consent in the presence of a study investigator. The research coordinator will collect data on demographics, medical history, and biomedical information. Note: Subjects who do not sign the consent form cannot participate in the study.
At each evaluation, patients will then be given time to complete the following patient reported outcome questionnaires: Forgotten Joint, Promis 29, Koos, SF 36. The physical therapist will then lead the patient through a series of functional measurement tests: Timed Up and Go (TUG), 4m and 10m walking speed test, sit/stand, Star Excursion Balance Test (SEBT), 2-minute walk, stair climb test (SCT), Single Leg Stance (SLS), and Y Balance Test (YBT). Videos may be taken to record progress.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Manual Revision TKA | – | Procedure: Manual revision total knee arthroplastyThese patients underwent revision TKA done manually |
| Robotic-assisted Revision TKA | – | Procedure: Robotic assisted revision total knee arthroplastyThese patients underwent revision TKA with robotic-assistance |
| Manual Primary TKA | – | Procedure: Manual total knee arthroplastyThese patients received primary TKAs done manually |
| Robotic-assisted Primary TKA | – | Procedure: Robotic assisted total knee arthroplastyThese patients received primary TKAs with robotic-assistance |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients who are candidates for primary or revision total knee arthroplasty.
Key inclusion criteria (4 listed)
- Candidate for TKA
- Speak English / understand study instructions--this is necessary to reliably complete the study questionnaires and understand study instructions which are not validated in other languages
- Have medical clearance from PCP, PI, or co-Investigator to participate in the study
- Willing to comply with all study procedures and be available for the duration of the study
Key exclusion criteria (11 listed)
- 2+ falls in the past year
- Unable to ambulate 100 ft without assistive device or rest period
- Acute illness
- Have a history of cardiovascular disease or hypertension not controlled by medication
- Severe visual impairment
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 |
|---|---|---|
| Robotic assisted total knee arthroplastyTotal knee arthroplasty with robotic assisatance | Procedure or surgery | Robotic-assisted Primary TKA |
| Manual total knee arthroplastyTotal knee arthroplasty without robotic assistance | Procedure or surgery | Manual Primary TKA |
| Robotic assisted revision total knee arthroplastyRevision total knee arthroplasty with robotic assistance | Procedure or surgery | Robotic-assisted Revision TKA |
| Manual revision total knee arthroplastyRevision total knee arthroplasty without robotic assistance | Procedure or surgery | Manual Revision TKA |
Primary outcome
Timed Up and Go (TUG)
Time frame: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
TUG requires the patient to sit in a chair, stand, walk to a line 3m away, turn, walk back to the chair, and sit again
4m and 10m Walking Speed Test
Time frame: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
2-minute Walk
Time frame: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
Stair Climb Test
Time frame: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
Y Balance Test
Time frame: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
The YBT requires the person to balance on one leg whilst simultaneously reaching as far as possible with the other leg in three separate directions: anterior, posterolateral, and posteromedial
4 secondary outcomes
Forgotten Joint Score
Time frame: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
Promis
Time frame: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
SF36
Time frame: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
KOOS
Time frame: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
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 17 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Arthritis Knee
Recruiting
Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
Knee Osteoarthristis
Not yet recruiting
Effects of Music During Walking on Pain and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis
Knee Osteoarthritis
Recruiting
Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial
Osteoarthritis, Knee
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
Knee Osteoarthritis
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. This study is not recruiting at the moment.
Kenneth Urish, MD 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?
An observational study of Arthritis Knee, 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 4 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 17 Aug 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go (TUG) (time frame: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery). The study lists 5 primary outcomes in all. 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 17 Aug 2026.