Back to resultsRobotic Arm Assisted Total Knee Arthroplasty
Primary Purpose
Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Robotic Arm Assisted Total Knee Arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
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.
Sites / Locations
- Coon Joint Replacement Institue; St. Helena Hospital
- Florida Orthopedic Institute
- Memorial Bone and Joint Research Foundation; Memorial Hermann Memorial City Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Robotic Assisted Total Knee Arthroplasty
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02058069
Brief Title
Robotic Arm Assisted Total Knee Arthroplasty
Official Title
Robotic Arm Assisted Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MAKO Surgical Corp.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Robotic Assisted Total Knee Arthroplasty
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Robotic Arm Assisted Total Knee Arthroplasty
Other Intervention Name(s)
MAKO Surgical Corp, RIO Total Knee Arthroplasty Application, MAKOplasty Total Knee Arthroplasty
Intervention Description
The total knee implant system used for this study was the Kinetis implant system (MAKO Surgical Corp.).
Primary Outcome Measure Information:
Title
Intra-Operative Complications
Description
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.
Title
Intra-Operative Complications
Description
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.
Title
Intra-Operative Complications
Description
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
Secondary Outcome Measure Information:
Title
Change in the Radiographic Assessment of Limb Alignment From Pre-Operative to 3 Months Post-Operative
Description
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
Title
Participants With Limb Alignment Difference <4.38 Degrees
Description
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
Other Pre-specified Outcome Measures:
Title
Patient Satisfaction - Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)
Description
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]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Gustke, MD
Organizational Affiliation
Florida Orthopedic Institute, Tampa General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Coon, MD
Organizational Affiliation
Coon Joint Replacement Institute, St. Helena Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefan Kreuzer, MD
Organizational Affiliation
Memorial Bone and Joint Research Foundation, Memorial Hermann Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Coon Joint Replacement Institue; St. Helena Hospital
City
St. Helena
State/Province
California
ZIP/Postal Code
94574
Country
United States
Facility Name
Florida Orthopedic Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33637
Country
United States
Facility Name
Memorial Bone and Joint Research Foundation; Memorial Hermann Memorial City Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
12. IPD Sharing Statement
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Robotic Arm Assisted Total Knee Arthroplasty
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