3DKnee™ System vs. the MJS Knee System | NCT00764803

Studies
3DKnee™ System vs. the MJS Knee System

NCT00764803

Sponsor

Encore Medical, L.P.

Status

Terminated

Last Update Posted

Mar 11, 2010Estimated

Enrollment

27Actual

Phase

Not provided

Conditions

Rheumatoid Arthritis
Traumatic Arthritis
Joint Disease Secondary to Osteoarthritis

Interventions

Encore 3DKnee™ system
Encore MJS™ Knee System

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Corporate decision to discontinue distribution of MJS Knee.

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Nov 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Sep 30, 2008

First Submission Date that Met QC Criteria

Sep 30, 2008

First Posted Date

Oct 2, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2010

Last Update Posted Date

Mar 11, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

The purpose of this study is to compare the survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System in a group of 600 patients for whom data collection is already under way. Approximately 300 patients have already received the MJS™ knee system and data, as described below, has been collected for these patients over a period of two years. A second group of 300 patients will receive the Encore 3DKnee™ system over the next two years, and equivalent data will be collected for these individuals. A portion of the data has been collected over the past year, and now we would like to obtain permission from the patients to analyze these data as well as collect an additional year of data.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2		Subjects who meet the indications for use and are implanted with the Encore MJS™ Knee System.	Device: Encore MJS™ Knee System
1		Subjects who meet the indications for and are implanted with the Encore 3DKnee™ system.	Device: Encore 3DKnee™ system

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Encore 3DKnee™ system	Device	Subjects with rheumatoid arthritis, traumatic arthritis or osteoarthritis who were implanted with the Encore 3DKnee™ system and willing to participate in the study.

Measure	Description	Time Frame
The survivorship and efficacy of the Encore 3DKnee™ system with that of the Encore MJS™ Knee System		2 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

This must be a primary knee replacement on this knee.
Patient is over 18 years of age or older
Patients must have one of the following
- rheumatoid or traumatic arthritis OR
- joint disease secondary to osteoarthritis
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)
Overt infection
Alcoholism or other addictions
Muscular, neurological or vascular deficiencies which compromise the affected extremity
Obesity
Marked bone loss
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Individuals who meet either the indications for use of the 3DKnee or the MJS knee system. Subjects must also meet the inclusion/exclusion criteria.

Sampling Method

Non-Probability Sample

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases