Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06821269

Functional Recovery After Total Knee Arthroplasty

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location status: Recruiting

Location contact

Kenneth Urish, MD, PhD

CONTACT

[email protected]

412-641-8609

Kenneth Urish, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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:

  • Do robotic-assisted revision TKAs have improved functional and perceived recovery when compared to manual revision TKAs?
  • Do robotic-assisted primary TKAs have improved functional and perceived recovery when compared to manual primary TKAs?
  • 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robotic assisted total knee arthroplasty

Procedure

Total knee arthroplasty with robotic assisatance

Manual total knee arthroplasty

Procedure

Total knee arthroplasty without robotic assistance

Robotic assisted revision total knee arthroplasty

Procedure

Revision total knee arthroplasty with robotic assistance

Manual revision total knee arthroplasty

Procedure

Revision total knee arthroplasty without robotic assistance

Primary outcomes

  1. Timed Up and Go (TUG)

    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

  2. 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 surgery

  3. 2-minute Walk

    Time frame: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery

  4. Stair Climb Test

    Time frame: anytime pre-operatively (baseline) and 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post surgery

  5. Y Balance Test

    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

Secondary outcomes

  1. Forgotten Joint Score

    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.

  2. Promis

    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

  3. SF36

    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.

  4. KOOS

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Victoria Wong, BA

CONTACT

[email protected]

6503880143

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Feb 11, 2025
Registry last updated
Dec 11, 2025

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.