Osteoarthritis
Conditions
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.
Interventions
PROCEDURETotal 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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Parameters | 1 year | Knee radiographs including an anteroposterior (AP) view and true lateral view, plus a patellar view |
Countries
United States
Outcome results
None listed