Post Market Study of the 3DKnee™ With E-plus Insert

NCT01551472 | Terminated

• 1 other identifier: PS-706
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System using Vitamin E UHMWPE tibial inserts for total knee replacement surgery.

Conditions

Degenerative Joint Disease; Osteoarthritis; Traumatic Arthritis

Outcome Measures

Primary Outcomes (1)

• Efficacy of the Vitamin E UHMWPE as part of the total knee system, measured by Knee Society Score Evaluation and total number of radiologic failures of the device.

  The (American) Knee Society Score has both an objective and a functional component. The objective score takes into account pain, flexion, stability, alignment, extension lag and flexion contracture. Overall success will be defined as a KSS score ≥ 80 at two years. Radiolucencies have been defined as two types, with one type being more common than the other. In the case of physiologic radiolucency, which is the most common type of radiolucency seen, there is a narrow line present that is well-defined around the prosthesis. This line is surrounded by a radio-dense line and tends to consolidate (disappear) within the first year. The second type of radiolucency, the pathologic radiolucency, is rarer and is associated with loosening and infection. It is a progressive, poorly defined radiolucency that is more than 2 mm thick and without a radiolucent line.

  2 year

Secondary Outcomes (5)

• Change in Knee Society Score from pre-surgery to 10 years

  10 year

• Change in WOMAC Osteoarthritis Index from pre-surgery to 10 years

  10 year

• Change in Oxford Knee Score from pre-surgery to 10 years

  10 year

• Change in response to Quality of Life questions from pre-surgery to 6 months and each year thereafter through 10 years

  10 years

• 6. Change in pain from pre-surgery to 6 months and each year thereafter through 10 years

  10 years

Study Arms (1)

3DKnee™ with e-plus Insert

Subjects who meet the indications for use criteria for the 3DKnee™ System with vitamin E UHMWPE tibial inserts (VE) and who are candidates for a primary knee arthroplasty.

Device: 3DKnee™ System with Vitamin E UHMWPE Tibial Inserts

Interventions

3DKnee™ System with Vitamin E UHMWPE Tibial Inserts DEVICE

This device is part of a total knee replacement system utilized in treating patients who are candidates for primary cemented total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function.

3DKnee™ with e-plus Insert

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects must be diagnosed with either osteoarthritis or traumatic arthritis and be candidates for a primary total knee arthroplasty. They must also meet the indications for use for the 3DKnee system with the vitamin E tibial insert.

You may qualify if:

• Subject must be a candidate for a total primary knee replacement.
• Subject must have knee joint disease related to degenerative joint disease, including osteoarthritis or traumatic arthritis
• Subject has a BMI ≤ 40.00 kg/m2
• Subject is likely to be available for evaluation for the duration of the study
• Subject is able and willing to sign the informed consent and follow study procedures
• Subject is not pregnant
• Subject must be between age 40 and age 75 at the time of consent

You may not qualify if:

• Subject has had a prior total or uni-knee replacement on this knee in the past (no revisions allowed in study)
• Subject has 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 or rheumatoid arthritis
• Subject has an active cancer or is a survivor for \<5 years except for squamous cell or basal cell skin cancer
• Subject has a chronic disease(s) where, in the opinion of the investigator, the disease will interfere with the patient's ability to follow the protocol
• Subject is currently a documented substance abuser (alcohol or other addictions)
• Subject has an infection, or history of infection (within the last 3 months), acute or chronic, local or systemic
• Subject has a history of muscular, neurological or vascular deficiencies which compromise the affected extremity
• Subject has a BMI \> 40.00 kg/m2
• Subject has loss of ligamentous structures
• Subject has high levels of physical activity and is unwilling to modify levels of physical activity commensurate with recommendations
• Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
• Subject is a prisoner
• Subject is pregnant
• Subject has known materials sensitivity (to metals)
• Subject is younger than 40 years (\<40) or older than 75 years (\>75) at the time of consent

Sponsors & Collaborators

• Encore Medical, L.P.: lead
• DJO Incorporated: collaborator

Study Sites (6)

Orthopaedic Surgery Specialists

Burbank, California, 91505, United States

Location

Orthopedic Specialists of North County

Oceanside, California, 92056, United States

Location

Institute for Orthopaedic Surgery and Sports Medicine

Fort Myers, Florida, 33919, United States

Location

St. Peter's Bone & Joint Surgery

City of Saint Peters, Missouri, 63376, United States

Location

New Mexico Orthopedics

Albuquerque, New Mexico, 87106, United States

Location

Texas Institute for Hip and Knee Surgery

Austin, Texas, 78751, United States

Location

MeSH Terms

Conditions

Joint Diseases; Osteoarthritis

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Arthritis; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2012
• First Posted: March 12, 2012
• Study Start: April 1, 2012
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-02

Locations

US (6)