The 3DKnee™ System: A Post-Market Study

Rheumatoid Arthritis Clinical Trial

Official title:

The 3DKnee™ System: A Post-Market Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00764673
• Other study ID #: PS - 703
• Status: Completed
• Phase: Phase 4
• First received: September 30, 2008
• Last updated: February 8, 2011
• Start date: October 2006
• Est. completion date: October 2010

Study information

• Verified date: February 2011
• Source: Encore Medical, L.P.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Avascular Necrosis
• Osteoarthritis
• Post Traumatic Arthritis
• Rheumatoid Arthritis
• Varus Deformity

Intervention

Device:
• 3DKnee
Subjects with knee osteoarthritis and willing to participate in the study

Locations

Country	Name	City	State
United States	St. Peter's Bone & Joint Surgery	St. Peters	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Encore Medical, L.P.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	2 year	No
Primary	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.	2-year	No
Primary	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.	2-year	Yes
Primary	Safety Assessment	Number of device related adverse events and device failures at the 2 year time frame.	2-year	Yes
Secondary	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.	2-year	No

External Links

•   Sponsor Company home page