Robot-Assisted vs. Manual Knee Replacement for Osteoarthritis

Recruiting at 2 trial locations

Overseen By Lauren Cole

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Infections, Neurological disorders, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

152 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Matthew P Abdel

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals aged 20-100 with osteoarthritis needing a knee replacement and can consent to the study. It's not for those with severe knee deformities, inflammatory arthritis, previous infections or replacements in the knee, BMI over 40, substance abuse issues, certain communicable diseases or psychiatric conditions.

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

You have a condition that affects your ability to walk or bear weight normally.

You have had a knee replacement surgery in the past and have an artificial knee joint.

You have serious leg deformities caused by injuries, diseases like arthritis or bone infections, or other problems like dislocated kneecap.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either robotically-assisted or manually-executed total knee arthroplasty

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Total Knee Robotically-Assisted

Trial Overview The study compares robot-assisted total knee arthroplasty (replacement) to the traditional manual method to see if there's a difference in how well patients do after surgery.

How Is the Trial Designed?

Group I: Total Knee Robotically-Assisted Experimental Treatment 1 Intervention

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.

Group II: Total Knee Manual-Executed by Surgeon Active Control 1 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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+