Osteoarthritis, Post-traumatic Arthritis, Rheumatoid Arthritis
Conditions
Brief summary
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.
Interventions
DEVICERobotic Arm Assisted Total Knee Arthroplasty
The total knee implant system used for this study was the Kinetis implant system (MAKO Surgical Corp.).
Sponsors
MAKO Surgical Corp.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subjects may be recruited in to the Investigation. * Age - The subject must be at least 21 years of age and skeletally mature as demonstrated radiographically by complete closure of the distal femoral and proximal tibial epiphyses. * Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained. * Subjects who, in the opinion of the Investigators and Approved Study Staff, are able to understand this Investigation and cooperate with the Investigation procedures and are willing to comply with all the required post-operative follow-ups. * Subjects who require a total knee arthroplasty for primary surgical management of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, moderate deformities or femoral condyle osteonecrosis as defined below. * Osteoarthritis: Kellgren-Lawrence Grade 3 or higher, with clinical history of an absence of major trauma to the joint; symptoms of pain, stiffness, swelling, and/or loss of motion; and with radiographic evidence of joint space narrowing, sub-chondral sclerosis, or peripheral osteophytes. * Post-Traumatic Arthritis: Kellgren-Lawrence Grade 3 or higher, with a clinical history of trauma to the targeted knee and subsequent pain, stiffness, swelling and loss of motion; and with radiographic evidence of joint space narrowing, sub-chondral sclerosis, or peripheral osteophytes. * Rheumatoid Arthritis: American College of Rheumatology classification score of 6 or higher, with a clinical history that demonstrates the following: morning stiffness for at least 1 hour and present for at least 6 weeks, swelling, loss of motion, and/or serum rheumatoid factor; and radiographic findings of narrow joint space, peri-articular osteopenia, and/or per-articular erosions. * Moderate Deformities: Moderate varus, valgus, flexion, or post-traumatic deformities of no more than 15° assessed radiographically. Moderate recurvatum of no more than 8° assessed radiographically. * Femoral Condyle Osteonecrosis: Loss of blood supply in the femoral condyle characterized by sudden onset of pain, possibly triggered by a specific seemingly routine activity or minor injury. Pain is often increased with activity and at night time and may cause swelling of the knee and sensitivity to touch and pressure and may result in limited motion. Confirmed by a bone scan, MRI, and/or x-ray. * Subjects whose anatomy is appropriate for the available range of implant sizes.
Exclusion criteria
* Patients who have had previous surgical procedures requiring implantation of hardware in their operative side knee, hip, or ankle that would result in metal artifact scatter in a CT scan. * Patients who have a fracture malunion of the distal femur or proximal tibia within 12cm of the knee center, assessed radiographically. * Patients who are pregnant, may become pregnant during the course of the Investigation, or are currently lactating. * Patients with allergies or suspected sensitivity to any patient-contacting component of the investigational device or the implant to be used in the study as listed below: * Femoral component: Cobalt Chromium alloy (CoCr) * Tibial component: Titanium alloy (Ti6Al4V) * Tibial inserts and patella component: Vitamin E infused ultra-high molecular weight polyethylene (UHMWPE) * Saw blade: 440C Stainless Steel * Patients who require bilateral total knee arthroplasty. * Patients who are currently on medical leave from their employment due to Workmen's Compensation. * Patients who are currently state or federal prisoners. * Patients who are currently Wards of the state. * Patients who are at high risk for poor healing or confounding outcomes or at excessive risk for surgery i.e.: clinically significant/being actively treated for renal, hepatic, cardiac, hematologic, or neurologic disease or poorly controlled diabetes (HbA1c \> 10 mg/dL) or previous history of joint infection. * Patients who are known drug or alcohol abusers or with psychological disorders as defined by DSM V that could affect follow-up care or treatment outcomes. * Patients who are currently involved in another clinical study with an investigational device. * Patients with current litigation pending related to medical treatment of any sort.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intra-Operative Complications | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Limb Alignment Difference <4.38 Degrees | Pre-op Plan, 3 Month Post Op | 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. |
| Change in the Radiographic Assessment of Limb Alignment From Pre-Operative to 3 Months Post-Operative | pre-op plan, 3 Month Post Op | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction - Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) | Pre-Op, 3 Month Post Op [change assessed between the two time periods] | The WOMAC collects information specific to osteoarthritis outcomes. The patient-response questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and function. Each question is scored from 0 to 4 for each set of factors, with 0 indicating no pain, stiffness, or limit in function, and 4 indicating extreme pain, stiffness, or limit in function. Total WOMAC scores range from 0 to 96 with lower values representing better outcomes. The posted mean, noted as a negative number, represents the mean DECREASE in total WOMAC score from pre-operative to 3 month post-operative patient assessment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Robotic Assisted Total Knee Arthroplasty Participants who underwent primary total knee arthroplasty using the Mako robotic arm system. | 89 |
| Total | 89 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Exclusion due to implant size | 5 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Robotic Assisted Total Knee Arthroplasty |
|---|---|
| Age, Continuous | 65.78 years STANDARD_DEVIATION 8.49 |
| Sex: Female, Male Female | 49 Participants |
| Sex: Female, Male Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 100 |
| serious Total, serious adverse events | 9 / 100 |
Outcome results
Primary
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.
Population: participants = knees.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Robotic Assisted Total Knee Arthroplasty | Intra-Operative Complications | 0 intra-operative complications |
Primary
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.
Population: participants = knees.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Robotic Assisted Total Knee Arthroplasty | Intra-Operative Complications | 0 intra-operative complications |
Primary
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
Population: participants = knees.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Robotic Assisted Total Knee Arthroplasty | Intra-Operative Complications | 0 intra-operative complications |
Secondary
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
Population: Of the 89 patients who received a robotic assisted total knee arthroplasty as part of the IDE, 2 patients were excluded from analysis for the Secondary Endpoint only due to issues related to the accurate measurement of limb alignment from the radiographs available (not for reasons involving the surgical procedure or clinical outcomes).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robotic Assisted Total Knee Arthroplasty | Change in the Radiographic Assessment of Limb Alignment From Pre-Operative to 3 Months Post-Operative | 1.54 degrees | Standard Deviation 1.01 |
Secondary
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
Population: Participants = knees
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Robotic Assisted Total Knee Arthroplasty | Participants With Limb Alignment Difference <4.38 Degrees | 87 Participants |
Other Pre-specified
Patient Satisfaction - Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)
The WOMAC collects information specific to osteoarthritis outcomes. The patient-response questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and function. Each question is scored from 0 to 4 for each set of factors, with 0 indicating no pain, stiffness, or limit in function, and 4 indicating extreme pain, stiffness, or limit in function. Total WOMAC scores range from 0 to 96 with lower values representing better outcomes. The posted mean, noted as a negative number, represents the mean DECREASE in total WOMAC score from pre-operative to 3 month post-operative patient assessment.
Time frame: Pre-Op, 3 Month Post Op [change assessed between the two time periods]
Population: participants = knees.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robotic Assisted Total Knee Arthroplasty | Patient Satisfaction - Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) | -33.1 units on a scale | Standard Deviation 20.04 |
Comparison: Change from pre-op to 3 monthsp-value: <0.001t-test, 2 sided