OsteoarthritisNCT00578851
A Clinical Investigation of the C2a-Taper™ Acetabular System
An observational study of Osteoarthritis and Avascular Necrosis, run by Biomet Orthopedics, LLC at 2 sites in United States.
Trial summary
The objective of this study is to gather clinical and survivorship information for the C2a-Taper™ Acetabular System, a ceramic-on-ceramic hip articulating system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Avascular Necrosis, Congenital Hip Dysplasia
- What is being tested?
- C2a - Taper™ Acetabular System
- Type of treatment
- Medical device
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2006to Oct 2015
- 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: Multi-Center study conducted in the United states on patients who meed the inclusion / exclusion criteria identified in the protocol.
Who may be able to join
- Skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis
Who cannot join
- Patients with: Osteoporosis, metabolic disorders, osteomalacia, rapid joint destruction, vascular insufficiency, muscular atrophy, and neuromuscular disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Physician's Clinic of Iowa, PCI
Cedar Rapids, Iowa, 52401
Lexington Clinic
Lexington, Kentucky, 40504
About this study
Official title: Post Approval Study of the C2a-Taper™ Acetabular System
The objective of this study is to gather clinical and survivorship information for the C2a-Taper™ Acetabular System, a ceramic-on-ceramic hip articulating system.
Read the detailed description
Study Design:
Phase 1
Sites will collect the following types of data:
Clinical-Total Harris Hip Score, Radiographic Evaluation- measurements on acetabular and femoral components Survivorship-removal/revision of one or more components (i.e. liner, head, shell and/or stem) Safety- All other adverse events
Follow-up Visit schedule
- 6 week ± 2 weeks
- 6 month ± 1 month
- 1 year ± 3 months
- 2 years ± 3 months
- 3 years ± 3 months
- 4 years ± 3 months
- 5 years ± 3 months
Phase 2:
Patients continue to be followed on an annual basis (Years 6-10) via mail. A self assessment form is sent directly to the subject on an annual basis starting in the 6th post-operative year.
- Being tested
- C2a - Taper™ Acetabular System
- Keywords
- Hip Arthroplasty, Hip Arthritis
- Medical subject headings
- Osteoarthritis, Osteonecrosis, Hip Dislocation, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C2a - Taper™ Acetabular SystemDevice
The C2a-Taper™ Acetabular System is a ceramic on ceramic hip articulating system. The bearing surfaces consist of ceramic femoral heads and acetabular liners.
| Study group | Role | What they receive |
|---|---|---|
| C2a Taper recipients | Patients who receive a THA with the C2a - Taper™ Acetabular System Receives: Device: C2a - Taper™ Acetabular System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score, Radiographic Evaluation
Measured: 5 years
Secondary outcomes (1)
Survivorship
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 posted21 Dec 2007 (estimated)
- Study startApr 2006
- Primary completionOct 2014
- Study completionOct 2015
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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomet Orthopedics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kara Mezger, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00578851
- Sponsor's protocol ID
- ORTHO.CR.H021
- Other IDs
- P050009
- Status last verified
- Jun 2017
- First submitted
- 19 Dec 2007
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Approval Study of the C2a-Taper™ Acetabular System
- ClinicalTrials.gov ID
- NCT00578851
- Acronym / sponsor ID
- ORTHO.CR.H021
- Keywords
- Hip Arthroplasty, Hip Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Biomet Orthopedics, LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 21 Dec 2007 (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 objective of this study is to gather clinical and survivorship information for the C2a-Taper™ Acetabular System, a ceramic-on-ceramic hip articulating system.
Detailed description
Study Design:
Phase 1
Sites will collect the following types of data:
Clinical-Total Harris Hip Score, Radiographic Evaluation- measurements on acetabular and femoral components Survivorship-removal/revision of one or more components (i.e. liner, head, shell and/or stem) Safety- All other adverse events
Follow-up Visit schedule
- 6 week ± 2 weeks
- 6 month ± 1 month
- 1 year ± 3 months
- 2 years ± 3 months
- 3 years ± 3 months
- 4 years ± 3 months
- 5 years ± 3 months
Phase 2:
Patients continue to be followed on an annual basis (Years 6-10) via mail. A self assessment form is sent directly to the subject on an annual basis starting in the 6th post-operative year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C2a Taper recipients | – | Device: C2a - Taper™ Acetabular SystemPatients who receive a THA with the C2a - Taper™ Acetabular System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Multi-Center study conducted in the United states on patients who meed the inclusion / exclusion criteria identified in the protocol.
Key inclusion criteria (1 listed)
- Skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis
Key exclusion criteria (1 listed)
- Patients with: Osteoporosis, metabolic disorders, osteomalacia, rapid joint destruction, vascular insufficiency, muscular atrophy, and neuromuscular disease
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 |
|---|---|---|
| C2a - Taper™ Acetabular SystemThe C2a-Taper™ Acetabular System is a ceramic on ceramic hip articulating system. The bearing surfaces consist of ceramic femoral heads and acetabular liners. | Device | C2a Taper recipients |
Primary outcome
Harris Hip Score, Radiographic Evaluation
Time frame: 5 years
1 secondary outcome
Survivorship
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 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Kara Mezger study director
Zimmer Biomet
2 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 Biomet Orthopedics, LLC at 2 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 1 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 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Harris Hip Score, Radiographic Evaluation (time frame: 5 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 Jun 2017.