Functional Recovery After Total Knee Arthroplasty
ConditionArthritis Knee
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-90
SponsorUniversity of Pittsburgh
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The study population consists of patients who are candidates for primary or revision total knee arthroplasty.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Robotic assisted total knee arthroplasty
Procedure/SurgeryTotal knee arthroplasty with robotic assisatance
Manual total knee arthroplasty
Procedure/SurgeryTotal knee arthroplasty without robotic assistance
Robotic assisted revision total knee arthroplasty
Procedure/SurgeryRevision total knee arthroplasty with robotic assistance
Manual revision total knee arthroplasty
Procedure/SurgeryRevision total knee arthroplasty without robotic assistance
Treatment groups
30 Participants
are divided into 4 treatment groupsGroup A: Manual Revision TKA1 intervention
Group B: Robotic-assisted Revision TKA1 intervention
Group C: Manual Primary TKA1 intervention
Group D: Robotic-assisted Primary TKA1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery2
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 surgery3
2-minute Walk
Time frame
anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery4
Stair Climb Test
Time frame
anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgerySecondary outcomes
1
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.
Time frame
anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery2
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
Time frame
anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery3
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.
Time frame
anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery4
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
Time frame
anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov