Retrospective Study of the Linear™ Hip

Rheumatoid Arthritis Clinical Trial

Official title:

Post-Market Study of the Linear™ Hip System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00764959
• Other study ID #: PS - 800
• Status: Terminated
• Phase: Phase 4
• First received: September 30, 2008
• Last updated: February 8, 2011
• Start date: October 2007
• Est. completion date: February 2011

Study information

• Verified date: February 2011
• Source: Encore Medical, L.P.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

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

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Hussamy Orthopedics	Vero Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Encore Medical, L.P.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The use and efficacy of the Encore Linear™ Hip System		2 year	No

External Links

•   Sponsor Company home page