Functional Recovery After Total Knee Arthroplasty

Last updated: August 6, 2025
Sponsor: University of Pittsburgh
Overall Status: Active - Recruiting

Phase

N/A

Condition

Joint Injuries

Treatment

Robotic assisted total knee arthroplasty

Manual total knee arthroplasty

Manual revision total knee arthroplasty

Clinical Study ID

NCT06821269
STUDY23060125
  • Ages 40-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Candidate for TKA

  • Speak English / understand study instructions--this is necessary to reliablycomplete the study questionnaires and understand study instructions which are notvalidated 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 thestudy

Exclusion

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 bymedication

  • Severe visual impairment

  • Lower-extremity amputation

  • Neurological, muscular, systemic, or connective tissue disorder affecting thefunction 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

Study Design

Total Participants: 30
Treatment Group(s): 4
Primary Treatment: Robotic assisted total knee arthroplasty
Phase:
Study Start date:
September 01, 2023
Estimated Completion Date:
May 01, 2027

Study 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.

Connect with a study center

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

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