Atlas Knee System Clinical System Clinical Study (USA)

NCT02934659 | Completed FDA Device

• 1 other identifier: CP0003 (formerly 102347)
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 9

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of this pilot study is the rate of individual subject success at 24 months. A subject will be declared a clinical success if all of the following conditions are met at the 24-month follow-up:

  1. Clinically significant improvement of at least 20% from baseline on the WOMAC pain questions in the KOOS questionnaire with a change of ≥10 points; 2. Clinically significant improvement of at least 20% from baseline on the WOMAC function questions in the KOOS questionnaire with a change of ≥10 points; 3. Maintenance of normal range of motion (ROM) defined as: (a) Knee flexion ≥ 90 degrees; and (b) Knee extension within 10 degrees of the "neutral" or zero degree position; 4. No subsequent surgical intervention of the medial knee (including device failures requiring removal or revision); and no serious device-related adverse events; 5. Maintenance of implant integrity as evaluated by radiographic assessment. a. Implant integrity will be assessed following the Atlas Image Evaluation Protocol (102345).

  Change at 24 months relative to baseline

Study Arms (1)

Investigational

EXPERIMENTAL

Intervention - Atlas Knee System device for medial knee osteoarthritis

Device: Atlas(TM) Knee System

Interventions

Atlas(TM) Knee System DEVICE

The Atlas System is an extra-capsular knee implant designed to unload the medial knee.

Also known as: Atlas System

Investigational

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects age 25 to 80 years at time of screening
• 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
• Has pain in the study knee as demonstrated by a minimum score of 40 (scale 0-100) on the WOMAC pain questions in KOOS
• 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.
• Knee flexion ≥90⁰
• Body Mass Index (BMI) of \<35 or weight \<300 lbs.
• Subjects who are able to give voluntary written informed consent to participate in this clinical investigation

You may not qualify if:

• Clinical symptoms or radiographic evidence of osteoarthritis in the lateral compartment of the study knee defined as Kellgren \& Lawrence (K\&L) grade of \> 1
• Clinical symptoms or radiographic evidence of osteoarthritis in the patella-femoral compartment of the study knee defined as K\&L grade ≥ 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
• 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
• 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
• Arthroscopic surgeries for joint lavage, meniscectomy, chondral debridement, and loose body removal are excluded if within 3 months prior to planned surgery date;
• Active infection, sepsis, osteomyelitis or history of septic arthritis in any joint;
• Previous lateral meniscectomy \>30% of the study knee
• Previous patellar surgery in the study knee
• Previous osteotomy or failed knee joint replacement in the study knee
• Hyperextension \>5⁰
• Flexion contracture \> 10⁰
• Pathologic ligamentous or meniscal instability (Lachman \> 1) as assessed by the Investigator;
• Suspected or documented allergy or hypersensitivity to cobalt, chromium, iron, or nickel metals;
• Rheumatoid arthritis, other forms of inflammatory joint disease or autoimmune disorder;

Sponsors & Collaborators

• Moximed: lead

Study Sites (9)

Banner-University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

Orthropaedic Research Foundation

Greenwood, Indiana, 46143, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02130, United States

Location

Hospital for Special Surgery (HSS)

New York, New York, 10021, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Ohio State University

Columbus, Ohio, 43202, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

University of Virginia, Dept. of Orthopaedic Surgery

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Rose Weinstein

  Moximed

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 17, 2016
• Study Start: November 1, 2016
• Primary Completion: July 9, 2019
• Study Completion: May 2, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)