Non-inflammatory Degenerative Joint DiseaseNCT01543230
CoMplete™ Acetabular Hip System
A study testing Total hip replacement in people with Non-inflammatory Degenerative Joint Disease and Osteoarthritis, run by DePuy Orthopaedics at 6 sites in United States.
Trial summary
The primary objective of this investigation is to evaluate survivorship at ten years. For this post approval study (PAS), a maximum acceptable hazard of revision is assumed to be a constant 1% per year. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Post-traumatic Arthritis
- What is being tested?
- Total hip replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2012to Oct 2013
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. If the subject:
- Was previously enrolled in the CoM IDE study with the Ceramic-on- Metal device, or
- Qualifies based on the approved labeling for the device; and
- 2. Is willing and able to provide informed patient consent for participation in the PAS study; and
- 3. Is willing and able to return for follow-up as specified by the PAS study protocol; and
- 4. Is willing and able to complete the hip outcomes questionnaire as specified by the PAS study protocol. A patient will be considered a "Valid Study Subject" when he/she has
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- consented to participate,
- authorized release of Personal Health Information (PHI),
- met all eligibility criteria through the operative stage, and
- received the implant as noted in this protocol.
Who cannot join
- Subjects will be excluded if, in the opinion of the investigator, the subject does not qualify based on approved labeling requirements or Subject Inclusion criteria.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Charlotte, North Carolina, 28207
Study site
Cincinnati, Ohio, 45236
Study site
Fort Collins, Colorado, 80525
Hip and Knee Arkansas Foundation
Little Rock, Arkansas, 72205
Orthopaedic Specialty Institute
Orange, California, 92868
Study site
Seattle, Washington, 98122
About this study
Official title: Ceramic on Metal Total Hip System, CoMplete™ Acetabular Hip System
The primary objective of this investigation is to evaluate survivorship at ten years. For this post approval study (PAS), a maximum acceptable hazard of revision is assumed to be a constant 1% per year.
Read the detailed description
This is a retrospective and prospective, non-randomized study of the Ceramic on Metal(CoM) device. This study will follow each subject through 10 years postoperatively. A total of 250 subjects will be enrolled in the investigation comprised of approximately 150 new PAS subjects and approximately 100 subjects recruited from the investigational device exemption study to the PAS.
- Being tested
- Total hip replacement
- Keywords
- Non-Inflammatory Degenerative Joint Disease
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip replacementDevice
Total hip arthroplasty (THA) using CoMplete™ Acetabular Hip System
| Study group | Role | What they receive |
|---|---|---|
| CoMplete™ Acetabular Hip System (CoM) | Experimental | Total hip arthroplasty (THA) using CoMplete™ Acetabular Hip System Receives: Device: Total hip replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship
Subjects will be seen each year through year 5 postoperatively for radiographic and clinical follow-up, and then at 8 and 10 years postoperatively for radiographic and clinical follow-up. Survivorship means the removal of either or both of the components (ceramic head or metal liner).
Measured: 10 years
Secondary outcomes (1)
Metal Ion Levels
A subset of subjects will be measured for serum cobalt, serum chromium, erythrocytes cobalt, erythrocytes chromium, whole blood cobalt, and whole blood chromium levels. These subjects will also be measured for BUN and creatine levels.
Measured: 5 years, 8 years, and 10 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionOct 2013
- Study completionOct 2013
Why it stopped: Sponsor withdrew PMA
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-inflammatory Degenerative Joint DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dave Whalen, BS, DC, Study director, DePuy Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543230
- Sponsor's protocol ID
- 09014
- Status last verified
- Apr 2014
- First submitted
- 27 Feb 2012
- Last updated
- 8 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ceramic on Metal Total Hip System, CoMplete™ Acetabular Hip System
- ClinicalTrials.gov ID
- NCT01543230
- Acronym / sponsor ID
- 09014
- Keywords
- Non-Inflammatory Degenerative Joint Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor withdrew PMA
- Enrolment
- 58 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 2 Mar 2012 (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 primary objective of this investigation is to evaluate survivorship at ten years. For this post approval study (PAS), a maximum acceptable hazard of revision is assumed to be a constant 1% per year.
Detailed description
This is a retrospective and prospective, non-randomized study of the Ceramic on Metal(CoM) device. This study will follow each subject through 10 years postoperatively. A total of 250 subjects will be enrolled in the investigation comprised of approximately 150 new PAS subjects and approximately 100 subjects recruited from the investigational device exemption study to the PAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CoMplete™ Acetabular Hip System (CoM) | Experimental | Device: Total hip replacementTotal hip arthroplasty (THA) using CoMplete™ Acetabular Hip System |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. If the subject:
- 2. Is willing and able to provide informed patient consent for participation in the PAS study; and
- 3. Is willing and able to return for follow-up as specified by the PAS study protocol; and
- 4. Is willing and able to complete the hip outcomes questionnaire as specified by the PAS study protocol. A patient will be considered a "Valid Study Subject" when he/she has
Key exclusion criteria (1 listed)
- Subjects will be excluded if, in the opinion of the investigator, the subject does not qualify based on approved labeling requirements or Subject Inclusion criteria.
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 |
|---|---|---|
| Total hip replacementTotal hip arthroplasty (THA) using CoMplete™ Acetabular Hip System | Device | CoMplete™ Acetabular Hip System (CoM) |
Primary outcome
Survivorship
Time frame: 10 years
Subjects will be seen each year through year 5 postoperatively for radiographic and clinical follow-up, and then at 8 and 10 years postoperatively for radiographic and clinical follow-up. Survivorship means the removal of either or both of the components (ceramic head or metal liner).
1 secondary outcome
Metal Ion Levels
Time frame: 5 years, 8 years, and 10 years postoperatively
Results and safety
The study was stopped early (reason given: Sponsor withdrew PMA). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2014.
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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.
Dave Whalen, BS, DC study director
DePuy Orthopaedics
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total hip replacement in people with Non-inflammatory Degenerative Joint Disease and Osteoarthritis, run by DePuy Orthopaedics at 6 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 10 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: stopped early, as of the sponsor's last update on 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 was stopped early (reason given: Sponsor withdrew PMA). 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?
Survivorship (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 8 Apr 2014.