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Functional Recovery After Total Knee Arthroplasty

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 40 Years - 90 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06821269
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Pittsburgh
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Kenneth Urish, MD PhD
Principal Investigator Affiliation University of Pittsburgh
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Arthritis Knee
Additional Details

The choice to perform robotic assisted vs.#46;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.

Arms & Interventions

Arms

: Manual Revision TKA

These patients underwent revision TKA done manually

: Robotic-assisted Revision TKA

These patients underwent revision TKA with robotic-assistance

: Manual Primary TKA

These patients received primary TKAs done manually

: Robotic-assisted Primary TKA

These patients received primary TKAs with robotic-assistance

Interventions

Procedure: - Robotic assisted total knee arthroplasty

Total knee arthroplasty with robotic assisatance

Procedure: - Manual total knee arthroplasty

Total knee arthroplasty without robotic assistance

Procedure: - Robotic assisted revision total knee arthroplasty

Revision total knee arthroplasty with robotic assistance

Procedure: - Manual revision total knee arthroplasty

Revision total knee arthroplasty without robotic assistance

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Pittsburgh, Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213

Site Contact

Kenneth Urish, MD, PhD

[email protected]

412-641-8609

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