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The 3DKnee™ System: A Post-Market Study

Primary Purpose

Osteoarthritis, Rheumatoid Arthritis, Post Traumatic Arthritis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
3DKnee
Sponsored by
Encore Medical, L.P.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Peter's Bone & Joint Surgery

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Primary

Arm Description

Post market study

Outcomes

Primary Outcome Measures

Knee Society Score Evaluation
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).
Knee Society Function Score
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.
Number of Participants With >2mm Wide at the Bone/Cement Interface or a >3 Degree or >3 mm Migration (Shift) of the Component.
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.
Safety Assessment
Number of device related adverse events and device failures at the 2 year time frame.

Secondary Outcome Measures

Oxford Knee Score
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.

Full Information

First Posted
September 30, 2008
Last Updated
February 8, 2011
Sponsor
Encore Medical, L.P.
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1. Study Identification

Unique Protocol Identification Number
NCT00764673
Brief Title
The 3DKnee™ System: A Post-Market Study
Official Title
The 3DKnee™ System: A Post-Market Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Encore Medical, L.P.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Rheumatoid Arthritis, Post Traumatic Arthritis, Varus Deformity, Avascular Necrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Primary
Arm Type
Other
Arm Description
Post market study
Intervention Type
Device
Intervention Name(s)
3DKnee
Intervention Description
Subjects with knee osteoarthritis and willing to participate in the study
Primary Outcome Measure Information:
Title
Knee Society Score Evaluation
Description
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).
Time Frame
2 year
Title
Knee Society Function Score
Description
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.
Time Frame
2-year
Title
Number of Participants With >2mm Wide at the Bone/Cement Interface or a >3 Degree or >3 mm Migration (Shift) of the Component.
Description
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.
Time Frame
2-year
Title
Safety Assessment
Description
Number of device related adverse events and device failures at the 2 year time frame.
Time Frame
2-year
Secondary Outcome Measure Information:
Title
Oxford Knee Score
Description
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.
Time Frame
2-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John McAllister, M.D.
Organizational Affiliation
St. Peter's Bone and Joint Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Peter's Bone & Joint Surgery
City
St. Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.djosurgical.com
Description
Sponsor Company home page

Learn more about this trial

The 3DKnee™ System: A Post-Market Study

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