European Post-Market Study for Medial Knee Osteoarthritis Treated With the Atlas Knee System for Load Reduction

NCT02663414 | Withdrawn

• 1 other identifier: CLIN-102359
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to collect post market data on safety and performance of the Atlas Knee System in patients with osteoarthritis (OA) of the medial knee compartment through a 24 months post-operative follow-up period.

Conditions

Osteoarthritis (OA) of the Medial Knee Compartment

Outcome Measures

Primary Outcomes (4)

• Pain

  Change from baseline to 24 months in pain measured by the Knee injury and Osteoarthritis outcome score (KOOS).

  Baseline and 24 month

• Function

  Change from baseline to 24 months in patients functional outcome using the Knee injury and Osteoarthritis outcome score (KOOS).

  Baseline and 24 month

• Knee range of motion

  No change from baseline to 24 months in Knee range of motion as measured by Investigator Orthopedic examination.

  Baseline and 24 month

• Monitoring of adverse events

  Type, frequency, severity, and relatedness of adverse events will be assessed throughout the study.

  Baseline to 24 month

Secondary Outcomes (3)

• Function

  Baseline and 24 month

• Activity

  Baseline and 24 month

• Health outcome

  Baseline and 24 month

Study Arms (1)

Atlas device

EXPERIMENTAL

Each patient in this arm will receive the Atlas Knee System device on the medial side of the symptomatic knee.

Device: Atlas Knee System

Interventions

Atlas Knee System DEVICE

The Atlas Knee System is an approved device (CE Marked) and is an extra-capsular knee implant specifically designed to treat patients with uni-compartmental, medial knee osteoarthritis (OA).

Also known as: Atlas System

Atlas device

Eligibility Criteria

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

You may qualify if:

• Male or female, older than 25 years of age;
• Have clinical symptoms in the study knee such as pain primarily localized to the medial aspect of the knee and generally exacerbated by weight bearing;
• Radiographic confirmation of osteoarthritis of the medial knee compartment without bony erosion and best assessed using a Rosenberg view X-ray;
• Have failed at least 6 months of conservative therapy prior to surgery with continued OA pain. Prior conservative therapy is defined as treatment including at least one of the following (OARSI Recommendations)9:
• Lifestyle modification;
• Weight loss, if BMI \>35;
• Pain relievers;
• Physical therapy;
• Assist devices (Canes, Orthotics, Braces, etc.);
• Intra-articular (IA) injections.
• Have active knee flexion ≥ 90⁰;
• Are able to give voluntary, written informed consent to participate in this clinical investigation.
• Are, in the opinion of the Clinical Investigator, able to understand this clinical investigation, cooperate with the investigational procedures, and are willing to return for all required post-treatment follow up visits.

You may not qualify if:

• Clinical symptoms and radiographic evidence of OA in the lateral compartment of the study knee;
• Clinical symptoms and radiographic evidence of OA in the patella-femoral compartment of the study knee;
• Tibio-femoral alignment of \> 10⁰ of varus, or \> 6° of valgus, as measured using anatomical axis on a long standing (Hip-Knee-Ankle) antero-posterior (AP) view X-ray, or tibio-femoral alignment of \> 16⁰ of varus, or \> 0⁰ of valgus as measured using mechanical axis on a long 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, medial meniscectomy, chondral debridement, and loose body removal if within 3 months prior to planned surgery date; Note: concomitant diagnostic arthroscopy including debridement during Atlas procedure is permitted.
• Active infection, sepsis, osteomyelitis or history of septic arthritis in any joint;
• Rheumatoid arthritis, other forms of inflammatory joint disease or autoimmune disorder;
• Excessive scarring of soft tissue structures of the medial knee;
• Hyperextension \> 10⁰;
• Pathologic ligamentous instability (\> 1 Medial collateral ligament injury or Lachman \> 1 without hard stop) as assessed by the Investigator on physical examination;
• Severe deformities leading to impaired fixation or improper positioning of the implant;
• Paget's disease or metabolic disorders which may affect bone formation;
• Known or suspected diagnosis of Osteomalacia;
• Known or suspected diagnosis of Osteonecrosis;
• Known or suspected diagnosis of Osteoporosis;

Sponsors & Collaborators

• Moximed: lead

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Tessa Yamut

  Moximed

  STUDY CHAIR

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: January 14, 2016
• First Posted: January 26, 2016
• Study Start: March 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: March 21, 2019

Record last verified: 2019-03