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MAKO-Uni-Knee Arthroplasty

This study is not yet open for participant recruitment.
Verified November 2017 by Foundation for Orthopaedic Research and Education
Sponsor:
ClinicalTrials.gov Identifier:
NCT03354195
First Posted: November 27, 2017
Last Update Posted: November 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Stryker Orthopaedics
Information provided by (Responsible Party):
Foundation for Orthopaedic Research and Education
  Purpose

This study represents a single-surgeon/institution, non-randomized, consecutive series, prospective and comparative cohort design. The Principal Investigator is anticipating 100 study patients in the INTACT group and 35 patients in the Anterior Cruciate Ligament-Deficient group.The schedule of events lists the imaging procedures and questionnaires to be completed at each visit.

Subjects will be consented and enrolled within 28 days prior to surgery and participate in follow-up visits for two years following their Unicompartmental Knee Arthroplasty. A 3-year enrollment duration is anticipated to enroll a minimum and consecutive series of 25 patients in the experimental Anterior Cruciate Ligament-deficient group. Over the same enrollment duration, 100+ patients with intact Anterior Cruciate Ligaments are expected to be in the control group and undergo Unicompartmental Knee Arthroplasty. The enrollment duration (3 years) and total study duration (5 years) are based on patient volume estimates provided by the Principal Investigator.


Condition Intervention
Clinical Outcomes Procedure: Unicompartmental knee arthroplasty with the Mako Robotic Arm-assisted system.

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

During surgery, the ACL will be inspected, manually stressed and probed following standard techniques to assess its structure and function.(20, 21) The state of the ACL will be recorded and classified into one of four categories per these intra-operative examinations (22) and available pre-operative MRI data:

Group 1 - intact ACL ligament

Group 2 - intact but fibrillated (frayed) ligament)

Group 3 - nearly completely torn ligament (>50% and disrupted)

Assessment will be performed by the PI. Knees with ACLs classified as Group 1 and Group 2 will be accepted as functionally intact. Those classified as Group 3 will be deemed as having functionally absent ACLs

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Clinical Outcomes and Function Study Between MAKO Robotic-Arm Assisted UKA in ACL Intact and Deficient Knees

Resource links provided by NLM:


Further study details as provided by Foundation for Orthopaedic Research and Education:

Primary Outcome Measures:
  • Functional and Clinical Outcomes comparing patients with and without intact Anterior Cruciate Ligaments undergoing arthroplasty with MAKO Robotic-Arm Assisted Surgery. [ Time Frame: Baseline (screening), compared to a 24 month follow-up visit. There are also several additional time points from 3 weeks, 6 weeks, 3 months, 6 months and 12 months where the functional and clinical outcomes are assessed. ]
    Knee Society Score (KSS) and Knee Injury and Osteoarthritis Outcome Score (KOOS)


Secondary Outcome Measures:
  • Height and Weight [ Time Frame: Baseline (screening) ]
    to calculate subjects BMI

  • Computed Tomography [ Time Frame: Baseline (screening) ]
    A pre-operative CT scan is required as the Standard of Care for robotic-arm assisted knee procedures.

  • Magnetic Resonance Imaging [ Time Frame: Baseline (screening) ]
    MRI of the knee will be obtained prior to surgery using the parameters as requested by the Sponsor

  • Radiographs (3 views) [ Time Frame: Baseline (screening) ]
    Knee osteoarthritis will be diagnosed and subjectively graded by taking plain radiographs in accordance with the PI's Standard of Care, which include a (1) weight-bearing (WB) postero-anterior (PA) view, (2) sunrise view, and (3) lateral view. Degenerative disease of the knees will be graded per the Ahlback Grades 1-5, increasing in severity or Kellgren and Lawrence ,Grade 0-4, increasing in severity classification systems. The Principal Investigator also uses a subjective classification system of mild, moderate, or severe osteoarthritis, which is captured in the clinic note.

  • Global Satisfaction Survey [ Time Frame: Baseline (screening), 3 weeks, 6 weeks, 3 months, 12 months, 24 months ]
    2-page survey has been designed by the study team to track patient satisfaction after their UKA over time

  • Intra-Operative ACL Integrity [ Time Frame: Enrollment (procedure day) ]
    Knees with ACLs classified as Group 1 and Group 2 will be accepted as functionally intact. Those classified as Group 3 will be deemed as having functionally absent ACLs.


Estimated Enrollment: 135
Anticipated Study Start Date: January 1, 2018
Estimated Study Completion Date: October 2021
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1

Group 1 - intact ACL ligament will be accepted as functionally intact

unicompartmental knee arthroplasty with the Mako Robotic Arm-assisted system.

Procedure: Unicompartmental knee arthroplasty with the Mako Robotic Arm-assisted system.
All patients will receive the RESTORIS MCK (Multicompartmental Knee) Implant System, which is approved for use in unicompartmental knee arthroplasty with the Mako Robotic Arm-assisted system. The femoral component is constructed from cobalt chrome (CoCr) and the tibial component is constructed from an ultra-high molecular weight polyethylene (UHMWPE) insert and titanium (Ti) baseplate. UKA will be facilitated with MAKO Robotic-Arm Assisted Surgery, which has been shown in prior studies to lower pain and result in more accurate implant placement than manual UKA in a randomized controlled trial.(15)
Other Name: UKA with Mako Robotic Arm-assisted system
Active Comparator: Group 2

Group 2 - intact but fibrillated (frayed) ligament) will be accepted as functionally intact

unicompartmental knee arthroplasty with the Mako Robotic Arm-assisted system.

Procedure: Unicompartmental knee arthroplasty with the Mako Robotic Arm-assisted system.
All patients will receive the RESTORIS MCK (Multicompartmental Knee) Implant System, which is approved for use in unicompartmental knee arthroplasty with the Mako Robotic Arm-assisted system. The femoral component is constructed from cobalt chrome (CoCr) and the tibial component is constructed from an ultra-high molecular weight polyethylene (UHMWPE) insert and titanium (Ti) baseplate. UKA will be facilitated with MAKO Robotic-Arm Assisted Surgery, which has been shown in prior studies to lower pain and result in more accurate implant placement than manual UKA in a randomized controlled trial.(15)
Other Name: UKA with Mako Robotic Arm-assisted system
Active Comparator: Group 3

Group 3 - nearly completely torn ligament (>50% and disrupted) will be deemed as having functionally absent ACLs

unicompartmental knee arthroplasty with the Mako Robotic Arm-assisted system.

Procedure: Unicompartmental knee arthroplasty with the Mako Robotic Arm-assisted system.
All patients will receive the RESTORIS MCK (Multicompartmental Knee) Implant System, which is approved for use in unicompartmental knee arthroplasty with the Mako Robotic Arm-assisted system. The femoral component is constructed from cobalt chrome (CoCr) and the tibial component is constructed from an ultra-high molecular weight polyethylene (UHMWPE) insert and titanium (Ti) baseplate. UKA will be facilitated with MAKO Robotic-Arm Assisted Surgery, which has been shown in prior studies to lower pain and result in more accurate implant placement than manual UKA in a randomized controlled trial.(15)
Other Name: UKA with Mako Robotic Arm-assisted system

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects must meet these criteria to participate in this study:

  1. Patients with isolated, symptomatic femorotibial knee arthritis and candidates for UKA;
  2. Patients ≥ 21 years old;
  3. Patients with intact and non-functional ACLs as determined through pre-operative imaging, knee laxity tests, rotational stability tests, and intraoperative ACL classification;
  4. Patients willing and able to sign an informed consent;
  5. Patients willing and able to comply with 2-year follow-up commitments.

Exclusion Criteria:

Any subject who meets any of the exclusion criteria will be excluded from participation in this study:

  1. Patients with RA;
  2. Patients with BMI >40;
  3. Patients with ROM arc > 75°;
  4. Patients with greater than 10º of hyperextension;
  5. Patients with greater than 15º of varus or valgus deformity;
  6. Patients with active infection;
  7. Patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis;
  8. Patients without sufficient soft tissue integrity to provide adequate stability;
  9. Patients with either mental or neuromuscular disorders that do not allow control of the knee joint;
  10. Patients whose weight, age or activity level might cause extreme loads and early failure of the system.
  Contacts and Locations
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): NCT03354195


Contacts
Contact: Sherri E Leverett 813-558-6834 sleverett@foreonline.org
Contact: Kathy Kops 813-558-7903 kkops@foreonline.org

Sponsors and Collaborators
Foundation for Orthopaedic Research and Education
Stryker Orthopaedics
  More Information

Responsible Party: Foundation for Orthopaedic Research and Education
ClinicalTrials.gov Identifier: NCT03354195     History of Changes
Other Study ID Numbers: MM-MAKO-001
First Submitted: October 20, 2017
First Posted: November 27, 2017
Last Update Posted: November 27, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make the IPD available.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No