Back to resultsRCT Comparing Robotically-Assisted vs. Manually-Executed Total Knee Arthroplasties
Primary Purpose
Osteoarthritis
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Total Knee Robotically-Assisted
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility 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
Sites / Locations
- Mayo Clinic in Arizona
- Mayo Clinic Florida
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Total Knee Robotically-Assisted
Total Knee Manual-Executed by Surgeon
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Radiographic Parameters
Knee radiographs including an anteroposterior (AP) view and true lateral view, plus a patellar view
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03482349
Brief Title
RCT Comparing Robotically-Assisted vs. Manually-Executed Total Knee Arthroplasties
Official Title
A Prospective Randomized Clinical Trial (RCT) Comparing Functional and Radiographic Outcomes of Robotically-Assisted vs. Manually-Executed Total Knee Arthroplasties
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 16, 2018 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Total Knee Robotically-Assisted
Arm Type
Experimental
Arm Description
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.
Arm Title
Total Knee Manual-Executed by Surgeon
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Total Knee Robotically-Assisted
Intervention Description
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.
Primary Outcome Measure Information:
Title
Radiographic Parameters
Description
Knee radiographs including an anteroposterior (AP) view and true lateral view, plus a patellar view
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew P Abdel
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
RCT Comparing Robotically-Assisted vs. Manually-Executed Total Knee Arthroplasties
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