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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03482349
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Matthew P. Abdel, M.D., Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Procedure: Total Knee Robotically-Assisted Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Clinical Trial (RCT) Comparing Functional and Radiographic Outcomes of Robotically-Assisted vs. Manually-Executed Total Knee Arthroplasties
Actual Study Start Date : March 16, 2018
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: Total Knee Robotically-Assisted
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
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.

No Intervention: Total Knee Manual-Executed by Surgeon
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.



Primary Outcome Measures :
  1. Radiographic Parameters [ Time Frame: 1 year ]
    Knee radiographs including an anteroposterior (AP) view and true lateral view, plus a patellar view



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482349


Contacts
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Contact: Jessica Stutzman 507-266-1227 stutzman.jessica@mayo.edu

Locations
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United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Nalani A. Livingstone       livingstone.nalani@mayo.edu   
Sub-Investigator: Henry Clark         
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Matthew P Abdel         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Matthew P Abdel Mayo Clinic

Additional Information:
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Responsible Party: Matthew P. Abdel, M.D., Associat Professor of Orthopedics, College of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03482349    
Other Study ID Numbers: 17-002188
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases