NCT00764894

Terminated

Foundation Knee Study - Retrospective

Encore Medical, L.P.Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

PS - 701

Study Type

observational

Estimated enrollment

200

Locations

1 country

Sites

1

Timeline

Study Start

October 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2011

Actual (reported)

Study Completion

February 2011

Actual (reported)

Brief Summary

The purpose of this study is to evaluate the use and efficacy of the Encore Foundation Knee System in a group of 200 patients for whom data has already been collected.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Estimated enrollment: 200 participants
Study completion date: February 2011
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
October 2007
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 30, 2008
Actual (reported)
First Posted
October 2, 2008
Actual (reported)
Primary Completion
February 2011
Actual (reported)
Study Completion
February 2011
Actual (reported)

Last Updated: February 9, 2011
Status Verified: February 2011
Last Update Submitted: February 8, 2011

Conditions

Arthritis Secondary to Other Diseases Avascular Necrosis of the Femoral Condyles Inflammatory Tissue Disorders Osteoarthritis Post-traumatic Arthritis

Outcome Measures

Primary Outcomes (1)

The use and efficacy of the Encore Foundation Knee System
2 year

Study Arms (1)

Foundation Knee

Retrospective data collection on 510(k) approved device

Device: Foundation Knee

Interventions

Foundation KneeDevice

Subjects with degenerative joint disease (DJD), osteoarthritis or rheumatoid arthritis who received a primary Foundation Knee replacement and is willing to participate in the study.

Foundation Knee

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Individuals who meet the indications for use of the Foundation Knee device AND who meet the inclusion/exclusion criteria

You may qualify if:

Have knee joint disease related to one or more of the following

Sponsors & Collaborators

Encore Medical, L.P.
Industrylead

Study Sites (1)

Hussamy Orthopedics

Vero Beach, Florida, 32960, United States

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

Omar Hussamy, M.D.
Hussamy Orthopedics
PRINCIPAL INVESTIGATOR

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: RETROSPECTIVE
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

September 30, 2008

First Posted

October 2, 2008

Study Start

October 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2011

Actual (reported)

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The 3DKnee™ System: A Post-Market Study

Phase 4Completed

NCT00487565

Clinical Investigation of the LCS® Complete Posterior Stabilized Mobile-bearing Total Knee System

Not ApplicableCompleted

NCT00483977

A 2 Week Blinded Study For Pain Due To Arthritis Of The Knee

Phase 2Terminated

NCT00665548

Weight-Bearing Magnetic Resonance Imaging (MRI) for Analysis of Knee Osteoarthritis (OA)

Completed

NCT00819481

Post-Market Study of the 3DKnee™ System

Completed

osteoarthritis

post-traumatic arthritis

inflammatory tissue disorders

arthritis secondary to other diseases

Avascular necrosis of the femoral condyles;

Skeletal maturity

Less than 70 on the Knee Society Score (rating score)

Sufficient bone stock, as judged by radiographs, to support primary knee implant

Sufficient collateral ligaments to support the device, as judged by physician during stability testing (varus/valgus and flexion/extension) and less than 45 degree varus/valgus deformity and/or 90 degree flexion contracture

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

No infection present

No known materials sensitivity

You may not qualify if:

Skeletal immaturity
Greater than or equal to 70 on preoperative Knee Society Score (Rating Score)
Post-patellectomy
Insufficient bone quality which may affect implant stability
Insufficient collateral ligaments, as judged by the physician. Greater than 45 degree varus/valgus deformity and/or 90 degree flexion contracture.
Neurological conditions that might hinder patient's ability to follow study procedures (i.e., any that restrict physical activities such as Parkinson's Disease, Multiple Sclerosis, previous stroke which affects lower extremity)
Mental conditions that may interfere with ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the patient cannot understand the informed consent process, global dementia, prior strokes that interfere with the patient's cognitive abilities, senile dementia, and Alzheimer's Disease)
Prisoners
Conditions that place excessive demand on the implant (i.e. Charcot's joints, muscle deficiencies, refusal to modify postoperative physical activities, skeletal immaturity)
Patient is pregnant
Infection present
Materials sensitivity

Contact the study team to confirm eligibility.

Study Completion

February 2011

Actual (reported)

Last Updated

February 9, 2011

Record last verified: 2011-02

Source record

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Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00764894
Data provider: ClinicalTrials.gov
Source updated: 2011-02-09
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:26 UTC

Locations

US(1)

Study Stopped

Foundation Knee Study - Retrospective

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Foundation Knee

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Foundation Knee

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations