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Trial record 2 of 2 for:    moximed atlas

Atlas Knee System Clinical System Clinical Study (USA) (Atlas-USA)

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ClinicalTrials.gov Identifier: NCT02934659
Recruitment Status : Active, not recruiting
First Posted : October 17, 2016
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
Moximed

Brief Summary:
The primary objective of this pilot study is to collect data on the safety and effectiveness of the Atlas Knee System in subjects with medial knee osteoarthritis through 24 months postoperative follow-up.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: Atlas(TM) Knee System Not Applicable

Detailed Description:
This study is designed as a prospective, multicenter, open-label, single arm, pilot study. Eligible subjects with symptomatic osteoarthritis of the medial compartment of the knee will be enrolled in the study and will receive the Atlas Knee Implant. The study population will consist of adult subjects age 25 to 80 years, with a diagnosis of medial knee osteoarthritis (Kellgen and Lawrence Grades 1-4, except those with bony erosions) and has pain in the study knee demonstrated as an overall WOMAC pain score of ≥ 40 (scale 0-100).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Multi-Center, Single Arm, Pilot Study to Evaluate Symptom Relief in Subjects With Medial Knee Osteoarthritis Treated With the AtlasTM Knee System for Load Reduction
Study Start Date : November 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Investigational
Intervention - Atlas Knee System device for medial knee osteoarthritis
Device: Atlas(TM) Knee System
The Atlas System is an extra-capsular knee implant designed to unload the medial knee.
Other Name: Atlas System




Primary Outcome Measures :
  1. WOMAC pain [ Time Frame: Change at 24 months relative to baseline ]
    Improvement in knee pain relative to baseline measured by the WOMAC pain questions in the KOOS questionnaire

  2. WOMAC function [ Time Frame: Change at 24 months relative to baseline ]
    Improvement in function relative to baseline measured by the WOMAC function questions in the KOOS questionnaire

  3. Knee range of motion [ Time Frame: Change at 24 months relative to baseline ]
    Maintenance of knee range of motion

  4. Subsequent surgeries to medial compartment of knee or device related serious adverse events [ Time Frame: From baseline to 24 months ]
    No subsequent surgical intervention of the medial compartment of the knee (including device failures requiring removal or revision); and no serious device-related adverse events

  5. Implant integrity [ Time Frame: From baseline to 24 months ]
    Maintenance of implant integrity evaluated by radiographic assessment



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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subjects age 25 to 80 years at time of screening
  2. Clinical symptoms (such as pain primarily localized to the medial aspect of the knee and generally exacerbated by weight bearing) and radiographic evidence of osteoarthritis in the medial compartment of the knee

    • Weight-bearing Fixed Flexion view is recommended to verify radiographic evidence of osteoarthritis
    • KL Grade 1-4, except those with bony erosion
  3. Has pain in the study knee as demonstrated by a minimum score of 40 (scale 0-100) on the WOMAC pain questions in KOOS
  4. Has failed at least six (6) months of non-operative treatment with continued osteoarthritis (OA) pain. Prior treatment is defined as treatment with at least one of the following interventions (listed on the AAOS Clinical Practice Guidelines on the Treatment of Osteoarthritis of the Knee Non-arthroplasty):

    • Lifestyle modification
    • Weight loss, if BMI ≥35
    • Pain relievers
    • Physical Therapy
    • Orthotics (Splints, Braces)
    • Intra-Articular (IA) corticosteroid injections.
  5. Knee flexion ≥90⁰
  6. Body Mass Index (BMI) of <35 or weight <300 lbs.
  7. Subjects who are able to give voluntary written informed consent to participate in this clinical investigation
  8. Subjects, who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, cooperate with the investigational procedures, and are willing to return for all the required post-treatment follow up visits.

Exclusion Criteria:

  1. Clinical symptoms or radiographic evidence of osteoarthritis in the lateral compartment of the study knee defined as Kellgren & Lawrence (K&L) grade of > 1
  2. Clinical symptoms or radiographic evidence of osteoarthritis in the patella-femoral compartment of the study knee defined as K&L grade ≥ 3
  3. Clinical symptoms or radiographic evidence of osteoarthritis at the contralateral knee that would preclude activity of daily living, stair climbing, stair descending, or requires the use of an assist device
  4. Tibial-femoral alignment of more than 10⁰ of varus, or more than 6⁰ of valgus, as measured using anatomical axis on a standing Hip-Knee-Ankle or long standing AP view X-ray OR Hip-Knee-Ankle alignment of more than 16⁰ of varus, or more than 0⁰ of valgus, as measured using mechanical axis on a standing Hip-Knee-Ankle AP view x-ray
  5. Previous joint modifying surgery in the study knee within 12 months prior to planned surgery date such as ligament reconstruction, meniscus repair, cartilage transplantation, and microfracture
  6. Arthroscopic surgeries for joint lavage, meniscectomy, chondral debridement, and loose body removal are excluded if within 3 months prior to planned surgery date;
  7. Active infection, sepsis, osteomyelitis or history of septic arthritis in any joint;
  8. Previous lateral meniscectomy >30% of the study knee
  9. Previous patellar surgery in the study knee
  10. Previous osteotomy or failed knee joint replacement in the study knee
  11. Hyperextension >5⁰
  12. Flexion contracture > 10⁰
  13. Pathologic ligamentous or meniscal instability (Lachman > 1) as assessed by the Investigator;
  14. Suspected or documented allergy or hypersensitivity to cobalt, chromium, iron, or nickel metals;
  15. Rheumatoid arthritis, other forms of inflammatory joint disease or autoimmune disorder;
  16. Paget's disease or metabolic disorders which may impair bone formation;
  17. Known or suspected diagnosis of Osteomalacia;
  18. Known or suspected diagnosis of Osteonecrosis;
  19. Rapid joint destruction, marked bone loss or bone resorption apparent on x-ray;
  20. Osteoporosis or radiolucency of the femoral or tibial cortex on x-ray suggestive of moderate to severe osteoporosis, pathologic fractures, or bone mineral density T score of > 2.5 Standard Deviation (SD) below young adult reference mean (all subjects will be screened for risk of osteoporosis using the validated Osteoporosis Self-Assessment Tool (OST) score, subjects with high risk will undergo a DEXA scan to determine eligibility;
  21. Charcot's joint disease or other severe neurosensory deficits;
  22. Vascular insufficiency, muscular atrophy, neuromuscular disease;
  23. Immunologically suppressed or immunocompromised;
  24. History of systemic steroid treatment, medication use that affects bone metabolism (such as chemotherapy) within the previous 6 months, or radiotherapy within the previous 6 months
  25. Any significant medical condition including:

    • Diabetes mellitus requiring daily insulin therapy
    • Neuropathic pain or fibromyalgia, or any knee or other pain requiring chronic pain management
    • Advanced liver and kidney diseases
    • Congestive heart failure
    • Uncontrolled transient ischemic attack
    • Cancer
    • HIV (immunocompromised subject)
    • Radicular symptoms associated with lumbar spine pathology
    • Neurological disorders that result in gait disturbance
    • Restless leg syndrome
    • History of complex regional pain syndrome (Reflex Sympathetic Dystrophy (RSD); l. Significant psychiatric disorders (such as major depression, anxiety disorders, bipolar disorder, and schizophrenia); m. History or active substance and alcohol dependence and abuse (meeting standard diagnostic criteria described in the Diagnostic and Statistical Manual of Mental Disorders DSM-IV)
  26. Other factors that the investigator feels would interfere with the participation and completion of the study:

    • Planned relocation
    • Litigation for or workers compensation for musculoskeletal injuries or disorders
    • Uncooperative subject
    • Or any other reason.
  27. Pregnancy or planning to become pregnant
  28. Subjects who are currently involved in any investigational drug or device trial or have been enrolled in such trials within the last 3 months
  29. Prisoners or wards of the state.

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): NCT02934659


Locations
United States, Arizona
The Orthopedic Clinic Association
Phoenix, Arizona, United States, 85016
United States, Indiana
Orthropaedic Research Foundation
Greenwood, Indiana, United States, 46143
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02130
United States, New York
Hospital for Special Surgery (HSS)
New York, New York, United States, 10021
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43202
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Texas
Houston Methodist
Houston, Texas, United States, 77030
United States, Virginia
Univerisy of Virginia, Dept. of Orthopaedic Surgery
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Moximed
Investigators
Study Director: Tessa Yamut Moximed

Responsible Party: Moximed
ClinicalTrials.gov Identifier: NCT02934659     History of Changes
Other Study ID Numbers: 102347
First Posted: October 17, 2016    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases