Clinical trial NCT06821269: Functional Recovery After Total Knee Arthroplasty
Official title: Functional Recovery After Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arthritis Knee
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of patients who are candidates for primary or revision total knee arthroplasty.

Brief 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 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:

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Timed Up and Go (TUG)
timeFrame: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
measure: 4m and 10m Walking Speed Test
timeFrame: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
measure: 2-minute Walk
timeFrame: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
measure: Stair Climb Test
timeFrame: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
measure: Y Balance Test
timeFrame: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
Secondary outcomes:
measure: Forgotten Joint Score
timeFrame: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
measure: Promis
timeFrame: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
measure: SF36
timeFrame: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
measure: KOOS
timeFrame: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Kenneth Urish, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: