Robot-Assisted vs. Manual Knee Replacement for Osteoarthritis

N/A

Waitlist Available

Led By Matthew P Abdel

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare robot-assisted to manually-executed total knee replacement surgery in terms of functional outcomes.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, typical side effects of knee replacement surgeries may include pain at the site of operation, swelling, blood clots, infection risk and sometimes stiffness or difficulty moving the joint.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Radiographic Parameters

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Total Knee Robotically-AssistedExperimental Treatment1 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 SurgeonActive Control1 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.

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