Robotic Arm Assisted Total Knee Arthroplasty

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 Overview

• Status: Completed
• Conditions: Osteoarthritis; Rheumatoid Arthritis; Post-traumatic Arthritis
• Intervention / Treatment: Device: Robotic Arm Assisted Total Knee Arthroplasty

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • St. Helena, California, United States, 94574
      • Coon Joint Replacement Institue; St. Helena Hospital
  • Florida
    • Tampa, Florida, United States, 33637
      • Florida Orthopedic Institute
  • Texas
    • Houston, Texas, United States, 77024
      • Memorial Bone and Joint Research Foundation; Memorial Hermann Memorial City Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Robotic Assisted Total Knee Arthroplasty	Device: Robotic Arm Assisted Total Knee Arthroplasty; The total knee implant system used for this study was the Kinetis implant system (MAKO Surgical Corp.).; Other Names: MAKO Surgical Corp; RIO Total Knee Arthroplasty Application; MAKOplasty Total Knee Arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	3 Month Post Op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Pre-op Plan, 3 Month Post Op

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pre-Op, 3 Month Post Op [change assessed between the two time periods]

Collaborators and Investigators

• Sponsor: MAKO Surgical Corp.
• Investigators: Principal Investigator: Kenneth Gustke, MD, Florida Orthopedic Institute, Tampa General Hospital; Principal Investigator: Thomas Coon, MD, Coon Joint Replacement Institute, St. Helena Hospital; Principal Investigator: Stefan Kreuzer, MD, Memorial Bone and Joint Research Foundation, Memorial Hermann Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (ACTUAL): January 1, 2015
• Study Completion (ACTUAL): January 1, 2015

Study Registration Dates

• First Submitted: February 3, 2014
• First Submitted That Met QC Criteria: February 6, 2014
• First Posted (ESTIMATE): February 7, 2014

Study Record Updates

• Last Update Posted (ACTUAL): April 18, 2017
• Last Update Submitted That Met QC Criteria: March 21, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: RIOTKA_2014; 20131148 (OTHER: WIRB Protocol)