University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Location status: Recruiting
Location contact
Kenneth Urish, MD, PhD
CONTACT
Kenneth Urish, MD, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06821269
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.
Interested in participating?
Request Info40 year–90 year
All sexes
Observational
Pittsburgh, Pennsylvania, 15213, United States
Location status: Recruiting
Kenneth Urish, MD, PhD
CONTACT
Kenneth Urish, MD, PhD
PRINCIPAL_INVESTIGATOR
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:
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Total knee arthroplasty with robotic assisatance
Total knee arthroplasty without robotic assistance
Revision total knee arthroplasty with robotic assistance
Revision total knee arthroplasty without robotic assistance
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
Time frame: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
Time frame: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
Time frame: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
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
Time frame: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
The Forgotten Joint Score (FJS) is a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint.
Time frame: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
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
Time frame: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
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.
Time frame: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that helps patients and therapists assess knee injury outcomes over time
Contact information is provided by the study sponsor or research team.
University of Pittsburgh
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05788016
Arthritis Hip, Arthritis Knee
Birmingham, Alabama, United States
View Trial DetailsNCT05290818
Arthritis Knee, Arthropathy of Knee
Edinburgh, Lothian, United Kingdom
View Trial DetailsNCT06522152
Arthritis Knee, Meniscus Disorder
Bologna, Italy
View Trial DetailsNCT07216586
Arthritis, Arthritis Knee
Miami, Florida, United States
View Trial Details