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

NCT03482349 | Completed

• 1 other identifier: 17-002188
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 3

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Radiographic Parameters

  Knee radiographs including an anteroposterior (AP) view and true lateral view, plus a patellar view

  1 year

Study Arms (2)

Total Knee Robotically-Assisted

EXPERIMENTAL

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.

Procedure: Total Knee Robotically-Assisted

Total Knee Manual-Executed by Surgeon

NO INTERVENTION

Your orthopaedic surgeon will remove the damaged cartilage and bone, and then position the new metal and plastic implants to restore the alignment and function of your knee.

Interventions

Total Knee Robotically-Assisted PROCEDURE

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.

Total Knee Robotically-Assisted

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Matthew P Abdel

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associat Professor of Orthopedics, College of Medicine

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: March 29, 2018
• Study Start: March 16, 2018
• Primary Completion: March 13, 2025
• Study Completion: March 13, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)