The 3DKnee™ System: A Post-Market Study

NCT00764673 | Completed Phase 4 Results

• 1 other identifier: PS - 703
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Rheumatoid Arthritis; Post Traumatic Arthritis; Varus Deformity; Avascular Necrosis

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• Safety Assessment

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

  2-year

Secondary Outcomes (1)

• Oxford Knee Score

  2-year

Study Arms (1)

Primary

OTHER

Post market study

Device: 3DKnee

Interventions

3DKnee DEVICE

Subjects with knee osteoarthritis and willing to participate in the study

Primary

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Encore Medical, L.P.: lead

Study Sites (1)

St. Peter's Bone & Joint Surgery

City of Saint Peters, Missouri, 63376, United States

Location

Related Links

• Sponsor Company home page

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid; Osteonecrosis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Manager of Clinical Affairs
• Organization: DJO Surgical

jane.jacob@djosurgical.com

512-832-9500

Study Officials

• John McAllister, M.D.

  St. Peter's Bone and Joint Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 2, 2008
• Study Start: October 1, 2006
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 2, 2011
• Results First Posted: March 2, 2011

Record last verified: 2011-02

Locations

US (1)