OsteoarthritisNCT00764842
Efficacy of the CLP® Hip - Retrospective
An observational study of Osteoarthritis and Avascular Necrosis, run by Encore Medical, L.P. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the survivorship and efficacy of the Encore CLP® Hip stem in a group of no more than 200 patients from 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, Avascular Necrosis, Rheumatoid Arthritis
- What is being tested?
- Encore CLP® Hip stem
- Type of treatment
- Medical device
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 CLP Hip Stem AND who meet the inclusion/exclusion criteria
Who may be able to join
- Patients must be 18 years of age or older.
- Noninflammatory degenerative joint disease including
- Osteoarthritis of the natural femoral head
- Avascular necrosis of the natural femoral head
- Rheumatoid arthritis
- Correction of functional deformities
- Femoral fracture
- Patients must be able and willing to complete all study-related visits.
Who cannot join
- Anyone who is under 18 years of age
- Infection or sepsis
- Insufficient bone quality which may affect the stability of the implant
- Muscular, neurological or vascular deficiencies, which compromise the affected extremity
- Skeletally immature patients and cases where there is a loss of abductor musculature, poor bone stock, poor skin coverage around hip joint which would make the procedure unjustifiable
- Osteomyelitis
Show all 13Show fewer
- Rapid joint destruction or bone absorption apparent on roentgenogram
- Pathological conditions of the acetabulum which would prevent achieving proper range of motion, appropriate head stability, and/or a well-seated and supported smooth articulation of the head within the acetabulum
- Alcoholism or other addictions
- Materials sensitivity
- Loss of ligamentous structures
- High levels of physical activity (e.g., competitive sports, heavy physical labor)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-Market Study: The Efficacy of the CLP® Hip
The purpose of this study is to evaluate the survivorship and efficacy of the Encore CLP® Hip stem in a group of no more than 200 patients from whom data has already been collected.
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis
- Being tested
- Encore CLP® Hip stem
- Medical subject headings
- Osteoarthritis, Osteonecrosis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Encore CLP® Hip stemDevice
Subjects with osteoarthritis, rheumatoid arthritis or avascular necrosis of the natural femoral head who have received the Encore CLP® Hip stem and are willing to participate in the study.
| Study group | Role | What they receive |
|---|---|---|
| CLP Hip | Not described Receives: Device: Encore CLP® Hip stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
The survivorship and efficacy of the Encore CLP® Hip stem
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 startJan 2008
- 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Encore Medical, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- D. Kevin Lester, M.D., Principal investigator, Center for Excellence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764842
- Sponsor's protocol ID
- PS - 802
- Status last verified
- Feb 2011
- First submitted
- 30 Sep 2008
- Last updated
- 9 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Study: The Efficacy of the CLP® Hip
- ClinicalTrials.gov ID
- NCT00764842
- Acronym / sponsor ID
- PS - 802
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Enrollment and data collection insufficient to continue study.
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Encore Medical, L.P.Industry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 2 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the survivorship and efficacy of the Encore CLP® Hip stem in a group of no more than 200 patients from whom data has already been collected.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CLP Hip | – | Device: Encore CLP® Hip stem |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who meet the indications for use of the CLP Hip Stem AND who meet the inclusion/exclusion criteria
Key inclusion criteria (8 listed)
- Patients must be 18 years of age or older.
- Noninflammatory degenerative joint disease including
- Correction of functional deformities
- Femoral fracture
- Patients must be able and willing to complete all study-related visits.
Key exclusion criteria (13 listed)
- Anyone who is under 18 years of age
- Infection or sepsis
- Insufficient bone quality which may affect the stability of the implant
- Muscular, neurological or vascular deficiencies, which compromise the affected extremity
- Skeletally immature patients and cases where there is a loss of abductor musculature, poor bone stock, poor skin coverage around hip joint which would make the procedure unjustifiable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Encore CLP® Hip stemSubjects with osteoarthritis, rheumatoid arthritis or avascular necrosis of the natural femoral head who have received the Encore CLP® Hip stem and are willing to participate in the study. | Device | CLP Hip |
Primary outcome
The survivorship and efficacy of the Encore CLP® Hip stem
Time frame: 2 year
Results and safety
The study was stopped early (reason given: Enrollment and data collection insufficient to continue study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2011.
- Sponsor company home pageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
D. Kevin Lester, M.D. principal investigator
Center for Excellence
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Avascular Necrosis, run by Encore Medical, L.P. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Enrollment and data collection insufficient to continue study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The survivorship and efficacy of the Encore CLP® Hip stem (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2011.