Study Stopped
Enrollment and data collection insufficient to continue study.
Retrospective Study of the Linear™ Hip
Post-Market Study of the Linear™ Hip System
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2007
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 30, 2008
CompletedFirst Posted
Study publicly available on registry
October 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedFebruary 9, 2011
February 1, 2011
3.3 years
September 30, 2008
February 8, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
The use and efficacy of the Encore Linear™ Hip System
2 year
Study Arms (1)
Linear Hip
Encore Linear Hip System
Interventions
Subjects with degenerative joint disease (DJD), osteoarthritis or rheumatoid arthritis, have received the hip system and are willing to participate in the study.
Eligibility Criteria
Individuals who meet the indications for use of the Linear Hip device AND who meet the inclusion/exclusion criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hussamy Orthopedics
Vero Beach, Florida, 32960, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Omar Hussamy, M.D.
Hussamy Orthopedics
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 1, 2007
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
February 9, 2011
Record last verified: 2011-02