Retrospective Study of the Linear™ Hip

Terminated

• Conditions: Osteoarthritis; Correction of a Functional Deformity; Rheumatoid Arthritis; Avascular Necrosis; Femoral Fracture
• Interventions: Device: Encore Linear™ Hip System

• Registration Number: NCT00764959
• Lead Sponsor: Encore Medical, L.P.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-09-30
• Study First Submitted QC: 2008-10-01
• Study First Posted: 2008-10-02
• Status Verified: 2011-02
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Last Update Submitted: 2011-02-08
• Last Update Posted: 2011-02-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Linear Hip	Encore Linear™ Hip System	Encore Linear Hip System

Primary Outcome Measures

Name	Time	Method
The use and efficacy of the Encore Linear™ Hip System	2 year

Trial Locations

Locations (1)

Hussamy Orthopedics; 🇺🇸 Vero Beach, Florida, United States