Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2023-09-01
2027-05-01
Brief Summary
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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.
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Detailed Description
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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:
1. Do robotic-assisted revision TKAs have improved functional and perceived recovery when compared to manual revision TKAs?
2. Do robotic-assisted primary TKAs have improved functional and perceived recovery when compared to manual primary TKAs?
3. 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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Manual Revision TKA
These patients underwent revision TKA done manually
Manual revision total knee arthroplasty
Revision total knee arthroplasty without robotic assistance
Robotic-assisted Revision TKA
These patients underwent revision TKA with robotic-assistance
Robotic assisted revision total knee arthroplasty
Revision total knee arthroplasty with robotic assistance
Manual Primary TKA
These patients received primary TKAs done manually
Manual total knee arthroplasty
Total knee arthroplasty without robotic assistance
Robotic-assisted Primary TKA
These patients received primary TKAs with robotic-assistance
Robotic assisted total knee arthroplasty
Total knee arthroplasty with robotic assisatance
Interventions
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Manual total knee arthroplasty
Total knee arthroplasty without robotic assistance
Robotic assisted revision total knee arthroplasty
Revision total knee arthroplasty with robotic assistance
Manual revision total knee arthroplasty
Revision total knee arthroplasty without robotic assistance
Robotic assisted total knee arthroplasty
Total knee arthroplasty with robotic assisatance
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
40 Years
90 Years
ALL
No
Sponsors
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University of Pittsburgh
OTHER
Responsible Party
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Kenneth Urish
Associate Professor
Principal Investigators
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Kenneth Urish, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY23060125
Identifier Type: -
Identifier Source: org_study_id
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