RCT Comparing Robotically-Assisted vs. Manually-Executed Total Knee Arthroplasties

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Procedure: Total Knee Robotically-Assisted

• Registration Number: NCT03482349
• Lead Sponsor: Mayo Clinic

Brief Summary

This study will explore if there are any difference in functional outcomes between two different surgical procedures for total knee replacement: robot-assisted versus manually-executed total knee arthroplasty.

Detailed Description

Although total knee arthroplasty (TKA) is an effective treatment for end-stage knee arthritis, improvements in surgical technique remain a necessity. Contemporary designs have bolstered durability, but longer life expectancies have placed an even greater emphasis on survivorship. Additionally, patient satisfaction remains an issue.

A prospective randomized clinical trial (RCT) is proposed to compare robotically-assisted versus manually executed primary (TKAs). This study is designed to address the major short-term clinically important issues between the two types of procedures with special emphasis on functional outcome. Patients will be randomized to receive either a robotically-assisted or a manually-executed primary TKA.

Study Timeline

• Study First Submitted: 2018-02-15
• Study Start: 2018-03-16
• Study First Submitted QC: 2018-03-22
• Study First Posted: 2018-03-29
• Status Verified: 2025-03
• Primary Completion: 2025-03-13
• Study Completion: 2025-03-13
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

• Include all patients who are surgical candidates for primary TKA with unilateral osteoarthritis
• All eligible male or female patients between the ages of 20 years to 100 years old
• All included study participants must be able to give an informed consent.

Exclusion Criteria

• Significant femoral or tibial deformity due to congenital or traumatic etiologies, inflammatory arthritis, post-septic arthritis, osteomyelitis, prior infection of knee joint, osteoporosis, dislocated or fragmented patella
• The presence of infections, highly communicable diseases (e.g. AIDS), active tuberculosis, venereal disease, hepatitis.
• Significant neurological or musculoskeletal disorders or disease that may adversely affect normal gait or weight bearing.
• Presence of previous prosthetic knee replacement devices (of any type)
• Metastatic disease
• Psychiatric illness
• Drug or alcohol abuse
• Body mass index (BMI) > 40 kg/m2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Total Knee Robotically-Assisted	Total Knee Robotically-Assisted	The intervention is then performed with a new device and surgical procedure. At first the femur and the tibia are fixed to the operating table with a special clamp and the knee bones are exposed with the standard technique; then the surgeon digitizes the shape of the joint and the computer transfers the planned surgical strategy to a dedicated surgical robot. Resections are performed by the surgeon on a constrained guide held by the robot.

Primary Outcome Measures

Name	Time	Method
Radiographic Parameters	1 year	Knee radiographs including an anteroposterior (AP) view and true lateral view, plus a patellar view

Trial Locations

Locations (3)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States