Challenging The TKA Standard Of Care: Patient Specific Surgical Targets As Enabled By The Rosa

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This is a prospective, randomized controlled trial using the cruciate retaining, MC Persona to comparing the conventional TKA to ROSA assisted TKA. Patients will be randomized to one of three study trial arms. 1. Standard of care medial parapetallar approach (Control) 2. ROSA PSA medial parapetallar approach 3. ROSA PSA medial subvastus approach Participants will be followed for 1 year post surgery with a combination of perioperative parameters, imaging, patient reported outcomes, functional outcomes, blood and tissue sampling for inflammatory information and activity levels.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 80
Healthy Volunteers: f
View:

• Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty

• Varus knee deformity of 0 to 10 degrees

• Sufficient ligamentous function to warrant retention of the posterior cruciate ligament

• Between the ages of 21 and 80 inclusive

• Patients willing and able to comply with follow-up requirements and self-evaluations

• Ability to give informed consent

Locations
Other Locations
Canada
University Hospital
RECRUITING
London
Contact Information
Primary
Lyndsay Somerville, PhD
lyndsay.somerville@lhsc.on.ca
(519) 685-8500
Time Frame
Start Date: 2024-04-16
Estimated Completion Date: 2025-12
Participants
Target number of participants: 90
Treatments
No_intervention: Control
Standard of care medial parapetallar approach
Active_comparator: ROSA PSA Parapatellar Approach
Arm using the ROSA with PSA and medial parapetallar approach
Active_comparator: ROSA PSA Subvastus Approach
Arm using the ROSA with PSA and medial subvastus approach
Related Therapeutic Areas
Sponsors
Collaborators: Zimmer Biomet
Leads: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

This content was sourced from clinicaltrials.gov