← Back to Search

ROSA PSA Parapatellar Approach for Osteoarthritis

Phase 4

Recruiting

Led By Brent Lanting, PhD

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between the ages of 21 and 80 inclusive

Sufficient ligamentous function to warrant retention of the posterior cruciate ligament

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op

Awards & highlights

Study Summary

This trial will compare two different knee replacement surgery techniques using a robot-assisted approach and a conventional approach. Patients will be randomly assigned to one of three groups and followed for a year after surgery to assess

Who is the study for?

This trial is for adults aged 21-80 with knee osteoarthritis needing a total knee replacement, who have a specific type of knee alignment (varus deformity) between 0 to 10 degrees and healthy ligaments. Participants must be able to follow the study's procedures and provide consent.Check my eligibility

What is being tested?

The study compares traditional total knee arthroplasty (TKA) using the medial parapatellar approach with two ROSA robotic-assisted TKA approaches: one also using the medial parapatellar method, and another using the subvastus method. Patients are observed for one year post-surgery.See study design

What are the potential side effects?

While not explicitly listed, typical side effects from TKA may include pain at surgery site, swelling, blood clots, infection risk or issues related to anesthesia. Robotic assistance aims to minimize these but introduces risks associated with new technology.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 21 and 80 years old.

Select...

My knee's ligaments are strong enough to keep the back one.

Select...

I have severe knee pain from arthritis needing a knee replacement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-operation, 6-weeks post-op, 3-months post-op and 1-year post-op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Functional Outcome - 3D Ultrasound

Functional Outcome - Timed Up and Go test

Functional Outcome - Weight-bearing CT scan

+5 more

Secondary outcome measures

Health Ecominics

Trial Design

3Treatment groups

Active Control

Group I: ControlActive Control1 Intervention

Standard of care medial parapetallar approach

Group II: ROSA PSA Parapatellar ApproachActive Control1 Intervention

Arm using the ROSA with PSA and medial parapetallar approach

Group III: ROSA PSA Subvastus ApproachActive Control1 Intervention

Arm using the ROSA with PSA and medial subvastus approach

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Zimmer BiometIndustry Sponsor

373 Previous Clinical Trials

67,307 Total Patients Enrolled

129 Trials studying Osteoarthritis

33,034 Patients Enrolled for Osteoarthritis

Lawson Health Research InstituteLead Sponsor

661 Previous Clinical Trials

413,832 Total Patients Enrolled

21 Trials studying Osteoarthritis

5,477 Patients Enrolled for Osteoarthritis

Brent Lanting, PhDPrincipal InvestigatorLondon Health Sciences Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals who are older than 45 years eligible to participate in this study?

"Eligible candidates for this research must be aged between 21 and 80 years old. Notably, there are a total of 33 trials targeting individuals under 18 years old and 641 studies catering to those over the age of 65."

Answered by AI

What is the total number of participants currently under investigation in this clinical study?

"Yes, according to the information available on clinicaltrials.gov, this research is actively seeking eligible individuals. It was first listed on April 16th, 2024 and last revised on the same day. The goal is to enroll a total of 90 participants from one designated site."

Answered by AI

Has the FDA officially endorsed the ROSA PSA Parapatellar Approach?

"The safety assessment for the ROSA PSA Parapatellar Approach is rated 3 by our team at Power, as this Phase 4 investigation indicates that the treatment has obtained approval."

Answered by AI

Are potential participants still being enrolled in this research study at the moment?

"According to the details provided on clinicaltrials.gov, this medical investigation is currently in the recruitment phase. The trial was initially listed on 4/16/2024 and last modified on the same date."

Answered by AI

Recent research and studies

Clinical Orthopaedics & Related ResearchJournal

Patient Satisfaction After Total Knee Arthroplasty: Who Is Satisfied and Who Is Not?

Bourne, Robert B., Bert M. Chesworth, Aileen M. Davis, Nizar N. Mahomed, and Kory D. J. Charron. 2010. “Patient Satisfaction After Total Knee Arthroplasty: Who Is Satisfied and Who Is Not?”. Clinical Orthopaedics & Related Research. Ovid Technologies (Wolters Kluwer Health). doi:10.1007/s11999-009-1119-9.

clinicaltrials.govStudy

Using ROSA for Challenging The TKA Standard of Care

2024. "Using ROSA for Challenging The TKA Standard of Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06267482.