The Investigation will be conducted as a single-submission, multi-center study with approval from and in compliance of the Western Institutional Review Board (WIRB). The overall objective of this Investigation is to assess the safety and effectiveness of the Robotic Arm Interactive Orthopedic System (RIO) Total Knee Arthroplasty Application. Specifically, the study objectives are classified as follows: * Primary Objective: Surgeon assessment of standardized TKA complications both intra-operatively and at short term follow up. * Secondary Objective: Radiographic assessment of post-operative limb alignment. * Supporting Objective: Patient assessment of post-operative function and satisfaction.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
The total knee implant system used for this study was the Kinetis implant system (MAKO Surgical Corp.).
Coon Joint Replacement Institue; St. Helena Hospital
St. Helena, California, United States
Florida Orthopedic Institute
Tampa, Florida, United States
Memorial Bone and Joint Research Foundation; Memorial Hermann Memorial City Medical Center
Houston, Texas, United States
Intra-Operative Complications
Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.
Time frame: Subject will be assessed for these complications intra-operatively. The assessment occurs after the surgeon has completed the surgical procedure, but while the subject is still in the operating room with the surgeon.
Intra-Operative Complications
Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.
Time frame: Subjects will be assessed for incidence of intra-operative complications at the conclusion of their hospital stay, or an average of 3 days post-operatively.
Intra-Operative Complications
Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.
Time frame: 3 Month Post Op
Change in the Radiographic Assessment of Limb Alignment From Pre-Operative to 3 Months Post-Operative
Radiographic limb alignment of the operative knee according to the technique defined by Barrack et al. was assessed at the 3 month post-operative follow-up by two independent reviewers. The measured post-operative limb alignment was to be compared to the planned pre-operative limb alignment as extracted from the system log file.
Time frame: pre-op plan, 3 Month Post Op
Participants With Limb Alignment Difference <4.38 Degrees
The difference between the actual 3 month limb alignment was compared to the pre-op planned alignment. Any measurement difference \<4.38 was considered a success; \>4.38 degrees was considered a failure.
Time frame: Pre-op Plan, 3 Month Post Op
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