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Completed

NCT Number: NCT00764673

The 3DKnee™ System: A Post-Market Study

The purpose of this study is to evaluate the survivorship and efficacy of the Encore 3DKnee™ system in a group of patients who will receive the 3DKnee™ as a primary (first) orthopedic implant in the knee. Each knee will be designated as a separate subject and followed for a period of 2 years.

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Key information

Conditions

Osteoarthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Avascular Necrosis Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Post Traumatic Arthritis Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases Varus Deformity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Peter's Bone & Joint Surgery

City of Saint Peters, Missouri, 63376, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • This must be a primary knee replacement on this knee.
  • Have knee joint disease related to one or more of the following
  • degenerative joint disease, including osteoarthritis or traumatic arthritis
  • Avascular necrosis of the femoral condyles
  • Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
  • Moderate valgus, varus, or flexion deformities
  • Rheumatoid arthritis
  • Patient is likely to be available for evaluation for the duration of the study
  • Able and willing to sign the informed consent and follow study procedures
  • Patient is not pregnant
  • Patient must be over 18 years of age

Exclusion criteria

  • If there has been a total knee replacement on this knee in the past (no revisions allowed in study)
  • Infection, or history of infection, acute or chronic, local or systemic
  • Alcoholism or other addictions
  • Muscular, neurological or vascular deficiencies which compromise the affected extremity
  • Obesity
  • Insufficient bone quality
  • Loss of ligamentous structures
  • High levels of physical activity
  • Materials sensitivity
  • Prisoner
  • Mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements
  • Patient is pregnant
  • Is younger than 18 years of age

Treatment and study plan

3DKnee

Device

Subjects with knee osteoarthritis and willing to participate in the study

Primary outcomes

  1. Knee Society Score Evaluation

    Time frame: 2 year

    The Knee Society Score includes a knee rating and function score. This evaluation covers the knee rating score with three main parameters of pain, stability and range of motion and that flexion contracture, extension lag and misalignment should be dealt with as deductions. Thus, 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability. 50 points are allotted for pain, 25 for stability, and 25 for range of motion. Grading for KS Score: Excellent (90-100), Good (80-90), Fair (70-79) and Poor (<70).

  2. Knee Society Function Score

    Time frame: 2-year

    The Knee Society Score includes a knee rating and function score. Patient function considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score, which is also 100, is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. Walking ability is expressed in blocks (approximately 100 meters). Stair climbing is considered normal if the patient can ascend and descend stairs without holding a railing. A score of > or = to 60 on the function score is considered success.

  3. Number of Participants With >2mm Wide at the Bone/Cement Interface or a >3 Degree or >3 mm Migration (Shift) of the Component.

    Time frame: 2-year

    Radiographic failure is defined as a complete radiolucent line > 2mm wide at the bone/cement interface or a >3 degree or >3 mm migration (shift) of the component.

  4. Safety Assessment

    Time frame: 2-year

    Number of device related adverse events and device failures at the 2 year time frame.

Secondary outcomes

  1. Oxford Knee Score

    Time frame: 2-year

    Questionnaire on the perceptions of patients about a total knee replacement. Score between 0 and 48 where: 0 to 19 may indicate severe knee arthritis, 20 to 29 may indicate moderate to severe knee arthritis, 30 to 39 may indicate mild to moderate knee arthritis and 40 to 48 may indicate satisfactory joint function.

Sponsors and collaborators

Lead sponsor

Encore Medical, L.P.

Industry

Registry information

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Oct 2, 2008
Registry last updated
Mar 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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