OsteoarthritisPAS:IDENCT00721994
Post-PMA Approval Study: 10 Year Follow-Up IDE Subjects
An observational study of Osteoarthritis and Avascular Necrosis, run by Corin at 5 sites in United States.
Trial summary
primary endpoint of this Study is maintenance of "at least good clinical status" for a period of 10 years following initial implantation among Cormet procedures enrolled inthe pre-market IDE. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis
- What is being tested?
- Cormet Hip Resurfacing System
- Type of treatment
- Medical device
- How many people
- 231 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2008to Aug 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: IDE study subjects at 5 IDE study sites
Who may be able to join
- subjects enrolled in the Cormet IDE study at the 5 identified clinical sites
- Individuals who agree to participate in the study by signing the informed patient consent form
Who cannot join
- none
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Good Samaritan Hospital
Baltimore, Maryland, 21239
Cleveland Center for Joint Reconstruction
Cleveland, Ohio, 44113
Space Coast Orthopaedics Ctr.
Merritt Island, Florida, 32953
Kennedy White Orthopedics
Sarasota, Florida, 34233
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
About this study
Official title: Cormet Resurfacing Hip System Post PMA Approval Study (PMA #P050016)Pre-market (IDE) Study Group 10 Year Follow-Up With Metal Ion and Renal Function Data Collection Clinical Investigation Plan
primary endpoint of this Study is maintenance of "at least good clinical status" for a period of 10 years following initial implantation among Cormet procedures enrolled inthe pre-market IDE.
Read the detailed description
Maintaining "at least good clinical status" will be determined based upon the composite clinical success (CCS) criterion which includes no revision, removal, or replacement of any device component and a Harris Hip Total score of greater or equal to 80 points.
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis
- Being tested
- Cormet Hip Resurfacing System
- Keywords
- hip resurfacing, osteoarthritis, avascular necrosis, rheumatoid arthritis
- 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.
Cormet Hip Resurfacing SystemDevice
Also called Corin Cormet
Cormet Hip Resurfacing System
| Study group | Role | What they receive |
|---|---|---|
| 1 | IDE subjects who received the Cormet Hip Resurfacing device Receives: Device: Cormet Hip Resurfacing System |
What is being measured
The primary outcome is the main question the study is designed to answer.
to monitor the clinical performance of the Cormet implant system for a period of up to 10 years postoperative in order to confirm that there are no unexpected reductions in device performance following PMA approval
Measured: 10 years
Secondary outcomes (5)
Harris Hip Score components including total score, pain, function and range of motion
Measured: 10 years
device survival
Measured: 10 years
device related adverse events
Measured: 10 years
radiographic evaluation including radiolucencies, component migration, and femoral subsidence and tilt
Measured: 10 years
whole blood trace metals and renal function
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2017
- Study completionAug 2017
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
- Prospective
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathy Trier, Ph.D., Study director, Corin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721994
- Sponsor's protocol ID
- PAS: IDE subjects
- Acronym
- PAS:IDE
- Status last verified
- Nov 2018
- First submitted
- 23 Jul 2008
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cormet Resurfacing Hip System Post PMA Approval Study (PMA #P050016)Pre-market (IDE) Study Group 10 Year Follow-Up With Metal Ion and Renal Function Data Collection Clinical Investigation Plan
- ClinicalTrials.gov ID
- NCT00721994
- Acronym / sponsor ID
- PAS:IDE / PAS: IDE subjects
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis
- Keywords
- hip resurfacing, osteoarthritis, avascular necrosis, rheumatoid arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- CorinIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jun 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 25 Jul 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.
primary endpoint of this Study is maintenance of "at least good clinical status" for a period of 10 years following initial implantation among Cormet procedures enrolled inthe pre-market IDE.
Detailed description
Maintaining "at least good clinical status" will be determined based upon the composite clinical success (CCS) criterion which includes no revision, removal, or replacement of any device component and a Harris Hip Total score of greater or equal to 80 points.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Cormet Hip Resurfacing SystemIDE subjects who received the Cormet Hip Resurfacing device |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- IDE study subjects at 5 IDE study sites
Key inclusion criteria (2 listed)
- subjects enrolled in the Cormet IDE study at the 5 identified clinical sites
- Individuals who agree to participate in the study by signing the informed patient consent form
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Cormet Hip Resurfacing SystemAlso: Corin CormetCormet Hip Resurfacing System | Device | 1 |
Primary outcome
to monitor the clinical performance of the Cormet implant system for a period of up to 10 years postoperative in order to confirm that there are no unexpected reductions in device performance following PMA approval
Time frame: 10 years
5 secondary outcomes
Harris Hip Score components including total score, pain, function and range of motion
Time frame: 10 years
device survival
Time frame: 10 years
device related adverse events
Time frame: 10 years
radiographic evaluation including radiolucencies, component migration, and femoral subsidence and tilt
Time frame: 10 years
whole blood trace metals and renal function
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
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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.
Kathy Trier, Ph.D. study director
Corin
5 sites 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 Corin at 5 sites 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
to monitor the clinical performance of the Cormet implant system for a period of up to 10 years postoperative in order to confirm that there are no unexpected reductions in device performance following PMA approval (time frame: 10 years). 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 21 Nov 2018.