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Robotic Arm Assisted Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT02058069
Recruitment Status : Completed
First Posted : February 7, 2014
Results First Posted : February 12, 2016
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
MAKO Surgical Corp.

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Rheumatoid Arthritis Post-traumatic Arthritis Device: Robotic Arm Assisted Total Knee Arthroplasty Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Robotic Arm Assisted Total Knee Arthroplasty
Study Start Date : February 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

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




Primary Outcome Measures :
  1. Intra-Operative Complications [ 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. ]
    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.

  2. Intra-Operative Complications [ 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. ]
    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. Intra-Operative Complications [ Time Frame: 3 Month Post Op ]
    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 :
  1. Change in the Radiographic Assessment of Limb Alignment From Pre-Operative to 3 Months Post-Operative [ Time Frame: 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.

  2. Participants With Limb Alignment Difference <4.38 Degrees [ Time Frame: 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.


Other Outcome Measures:
  1. Patient Satisfaction - Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: 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.




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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02058069


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

Responsible Party: MAKO Surgical Corp.
ClinicalTrials.gov Identifier: NCT02058069     History of Changes
Other Study ID Numbers: RIOTKA_2014
20131148 ( Other Identifier: WIRB Protocol )
First Posted: February 7, 2014    Key Record Dates
Results First Posted: February 12, 2016
Last Update Posted: April 18, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases