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

Mayo Clinic152 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

152

Conditions

Osteoarthritis

Interventions

Total Knee Robotically-AssistedPROCEDURE

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic Florida

Jacksonville, Florida, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Radiographic Parameters

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

Time frame: 1 year

Data from ClinicalTrials.gov

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