Retrospective Study of the Linear™ Hip

NCT ID: NCT00764959

Last Updated: 2011-02-09

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

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Recruitment Status

TERMINATED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2011-02-28

Brief Summary

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

Detailed Description

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Conditions

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Osteoarthritis Rheumatoid Arthritis Femoral Fracture Correction of a Functional Deformity Avascular Necrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Linear Hip

Encore Linear Hip System

Encore Linear™ Hip System

Intervention Type DEVICE

Subjects with degenerative joint disease (DJD), osteoarthritis or rheumatoid arthritis, have received the hip system and are willing to participate in the study.

Interventions

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Encore Linear™ Hip System

Subjects with degenerative joint disease (DJD), osteoarthritis or rheumatoid arthritis, have received the hip system and are willing to participate in the study.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Have hip joint disease related to one or more of the following

* osteoarthritis
* rheumatoid arthritis
* femoral fracture
* correction of a functional deformity
* avascular necrosis of the natural femoral head
* Skeletal maturity
* 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
* Patient is over 18 years of age

Exclusion Criteria

* Skeletal immaturity
* Infection or sepsis
* Insufficient bone quality that may affect the stability of the implant
* Muscular, neurologic or vascular deficiencies which compromise the affected extremity
* Alcoholism or other addictions
* Prisoners
* High levels of physical activity
* Patient is pregnant
* Loss of ligamentous structures
* Materials sensitivity
* Patient is under 18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Encore Medical, L.P.

INDUSTRY

Sponsor Role lead

Responsible Party

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DJO Surgical

Principal Investigators

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Omar Hussamy, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hussamy Orthopedics

Locations

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Hussamy Orthopedics

Vero Beach, Florida, United States

Site Status

Countries

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United States

Related Links

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http://www.djosurgical.com

Sponsor Company home page

Other Identifiers

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PS - 800

Identifier Type: -

Identifier Source: org_study_id

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