NCT06821269

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
12mo left

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Sep 2023May 2027

Study Start

First participant enrolled

September 1, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 11, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Expected
Last Updated

December 11, 2025

Status Verified

December 1, 2025

Enrollment Period

2.7 years

First QC Date

February 6, 2025

Last Update Submit

December 4, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

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

  • 4m and 10m Walking Speed Test

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

  • 2-minute Walk

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

  • Stair Climb Test

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

  • Y Balance Test

    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

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

Secondary Outcomes (4)

  • Forgotten Joint Score

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

  • Promis

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

  • SF36

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

  • KOOS

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

Study Arms (4)

Manual Revision TKA

These patients underwent revision TKA done manually

Procedure: Manual revision total knee arthroplasty

Robotic-assisted Revision TKA

These patients underwent revision TKA with robotic-assistance

Procedure: Robotic assisted revision total knee arthroplasty

Manual Primary TKA

These patients received primary TKAs done manually

Procedure: Manual total knee arthroplasty

Robotic-assisted Primary TKA

These patients received primary TKAs with robotic-assistance

Procedure: Robotic assisted total knee arthroplasty

Interventions

Total knee arthroplasty with robotic assisatance

Robotic-assisted Primary TKA

Revision total knee arthroplasty without robotic assistance

Manual Revision TKA

Total knee arthroplasty without robotic assistance

Manual Primary TKA

Revision total knee arthroplasty with robotic assistance

Robotic-assisted Revision TKA

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of patients who are candidates for primary or revision total knee arthroplasty.

You may qualify if:

  • 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

You may not qualify if:

  • + 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Study Officials

  • Kenneth Urish, MD PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Wong, BA

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 6, 2025

First Posted

February 11, 2025

Study Start

September 1, 2023

Primary Completion

May 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

December 11, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations