OsteoarthritisNCT00764959
Retrospective Study of the Linear™ Hip
An observational study of Osteoarthritis and Rheumatoid Arthritis, run by Encore Medical, L.P. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis, Femoral Fracture
- What is being tested?
- Encore Linear™ Hip System
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Feb 2011
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals who meet the indications for use of the Linear Hip device AND who meet the inclusion/exclusion criteria
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- High levels of physical activity
- Patient is pregnant
- Loss of ligamentous structures
- Materials sensitivity
- Patient is under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-Market Study of the Linear™ Hip System
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.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Femoral Fracture, Correction of a Functional Deformity, Avascular Necrosis
- Being tested
- Encore Linear™ Hip System
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Femoral Fractures, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Encore Linear™ Hip SystemDevice
Subjects with degenerative joint disease (DJD), osteoarthritis or rheumatoid arthritis, have received the hip system and are willing to participate in the study.
| Study group | Role | What they receive |
|---|---|---|
| Linear Hip | Encore Linear Hip System Receives: Device: Encore Linear™ Hip System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The use and efficacy of the Encore Linear™ Hip System
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startOct 2007
- Primary completionFeb 2011
- Study completionFeb 2011
Why it stopped: Enrollment and data collection insufficient to continue study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Encore Medical, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Omar Hussamy, M.D., Principal investigator, Hussamy Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764959
- Sponsor's protocol ID
- PS - 800
- Status last verified
- Feb 2011
- First submitted
- 30 Sep 2008
- Last updated
- 9 Feb 2011
- Results posted
- No
- Data monitoring committee
- No