---
title: Post-Market Study of the 3DKnee™ System
nct_id: NCT00819481
overall_status: COMPLETED
sponsor: Encore Medical, L.P.
study_type: OBSERVATIONAL
primary_condition: Degenerative Joint Disease
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00819481.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00819481"
ct_last_update_post_date: 2021-03-16
last_seen_at: "2026-05-12T06:29:54.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Post-Market Study of the 3DKnee™ System

**Official Title:** Post-Market Study of the 3DKnee™ System Protocol No. PS -- 700

**NCT ID:** [NCT00819481](https://clinicaltrials.gov/study/NCT00819481)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 229
- **Lead Sponsor:** Encore Medical, L.P.
- **Conditions:** Degenerative Joint Disease, Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
- **Start Date:** 2009-02
- **Completion Date:** 2018-10
- **CT.gov Last Update:** 2021-03-16

## Brief Summary

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

## Detailed Description

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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **3DKnee** — Post Market Study

## Interventions

- **3DKnee™ System** (DEVICE) — Total knee replacement joint for subjects with knee osteoarthritis and willing to participate in the study.

## Primary Outcomes

- **efficacy of total knee system** _(time frame: 2 year)_

## Secondary Outcomes

- **change in Knee Society Score** _(time frame: 5 year)_
- **change in pain from pre-op to post-op** _(time frame: 5 year)_
- **patient satisfaction** _(time frame: 5 year)_
- **change in WOMAC Osteoarthritis Index from pre-surgery** _(time frame: 5 year)_
- **change in Oxford Knee Score from pre-surgery** _(time frame: 5 year)_

## Locations (8)

- Longo Orthopedics, Scottsdale, Arizona, United States
- Center for Excellence, Fresno, California, United States
- OrthoMaryland, Baltimore, Maryland, United States
- Metro Orthopedics and Sports Therapy, Silver Spring, Maryland, United States
- Leslie Orthopedics and Sports Medicine, Camdenton, Missouri, United States
- St. Peter's Bone & Joint Surgery, City of Saint Peters, Missouri, United States
- Texas Center for Joint Replacement, Plano, Texas, United States
- Rimrock Orthopedics, St. George, Utah, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.longo orthopedics|scottsdale|arizona|united states` — added _(2026-05-12)_
- `locations.center for excellence|fresno|california|united states` — added _(2026-05-12)_
- `locations.orthomaryland|baltimore|maryland|united states` — added _(2026-05-12)_
- `locations.metro orthopedics and sports therapy|silver spring|maryland|united states` — added _(2026-05-12)_
- `locations.leslie orthopedics and sports medicine|camdenton|missouri|united states` — added _(2026-05-12)_
- `locations.st. peter's bone & joint surgery|city of saint peters|missouri|united states` — added _(2026-05-12)_
- `locations.texas center for joint replacement|plano|texas|united states` — added _(2026-05-12)_
- `locations.rimrock orthopedics|st. george|utah|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00819481.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00819481*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*