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

Osteoarthritis Clinical Trial

Official title:

A Prospective Randomized Clinical Trial (RCT) Comparing Functional and Radiographic Outcomes of Robotically-Assisted vs. Manually-Executed Total Knee Arthroplasties

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03482349
• Other study ID #: 17-002188
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 16, 2018
• Est. completion date: March 25, 2025

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 152
• Est. completion date: March 25, 2025
• Est. primary completion date: March 25, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• Total Knee Robotically-Assisted
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.

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic Parameters	Knee radiographs including an anteroposterior (AP) view and true lateral view, plus a patellar view	1 year