Post-Market Study of the 3DKnee™ System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

229 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2018-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System for total knee replacement surgery.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The 3DKnee™ System: A Post-Market Study

NCT00764673

Osteoarthritis Rheumatoid Arthritis Post Traumatic Arthritis +2 more

COMPLETED PHASE4

A Global Clinical Study Investigating the Safety and Effectiveness of Smith and Nephew's Porous Knee System in Patients Who Need a Total Knee Replacement Due to Degenerative Arthritis, Post-traumatic Arthritis or Inflammatory Arthritis

NCT05197036

Osteoarthritis Post-traumatic Arthritis Rheumatoid Arthritis

ACTIVE_NOT_RECRUITING

A Study of Patients Treated With the Journey Deuce Bicompartmental Knee System

NCT01704326

Osteoarthritis

COMPLETED

Persona Revision Knee System Outcomes

NCT04821154

Arthroplasty Complications Infection Knee Disease +1 more

RECRUITING

Exactech Knee Systems Post Market Clinical Follow-up

NCT07107581

Knee Arthroplasty, Total Partial Knee Replacement

ENROLLING_BY_INVITATION

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Total knee replacement surgery is widely accepted as effective treatment for degenerative joint disease (DJD), osteoarthritis and rheumatoid arthritis. Relief of patient pain and return of mobility are the primary goals that can be accomplished by this surgery. The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System for total knee replacement surgery. The study will take place at multiple sites across the United States and be managed by the Encore Medical Clinical Affairs Department. The study will include only patients who meet the indications for use criteria for the 3DKnee™ System and who are candidates for primary knee arthroplasty.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Degenerative Joint Disease Osteoarthritis Rheumatoid Arthritis Traumatic Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

3DKnee

Post Market Study

3DKnee™ System

Intervention Type DEVICE

Total knee replacement joint for subjects with knee osteoarthritis and willing to participate in the study.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

3DKnee™ System

Total knee replacement joint for subjects with knee osteoarthritis and willing to participate in the study.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* This must be a primary knee replacement on this knee.
* Patient is over 18 years of age or older
* 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

Exclusion Criteria

* Is younger than 18 years of age
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No