Avascular NecrosisNCT01307384
Zimmer Continuum Metal on Polyethylene (MoP) PostMarket Clinical Followup (PMCF) Study
An observational study of Avascular Necrosis and Osteoarthritis, run by Zimmer Biomet at 2 sites in United States.
Trial summary
This is a prospective, multi-center, non-randomized, non-controlled study designed to obtain survival and outcome data on the Continuum Metal on Polyethylene Acetabular System when used in primary total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Avascular Necrosis, Osteoarthritis, Inflammatory Arthritis
- What is being tested?
- Continuum Metal on Polyethylene Acetabular System
- Type of treatment
- Medical device
- How many people
- 195 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Mar 2011to 17 Jul 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from surgeons medical practice who are candidates for primary hip arthroplasty. The study population will be comprised of 300 males and females who require primary total hip arthroplasty. Subjects will be enrolled at up to 7 clinical sites. Subjects must be geographically accessible throughout the study and be willing and able to attend required follow-up appointments. Candidates who express interest in study participation will be offered informed consent, and eligibility will be determined based upon the inclusion/exclusion criteria.
Who may be able to join
- Patient is 18 to 75 years of age, inclusive.
- Patient is skeletally mature.
- Patient qualifies for primary unilateral or bilateral (simultaneous or staged) total hip arthroplasty (THA) based on physical exam and medical history including the following:
- Avascular necrosis (AVN)
- Osteoarthritis
- Inflammatory arthritis (i.e., Rheumatoid arthritis)
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- Post-traumatic arthritis
- Patient has no history of previous prosthetic replacement device of any type, including surface replacement arthroplasty, endoprosthesis, etc. of the affected hip joint(s).
- Patient has moderate, marked or disabling pain.
- Patient is willing and able to provide written informed consent.
- Patient is willing and able to cooperate in the required post-operative therapy.
- Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
- Patient has participated in the Informed Consent process and has signed the IRB approved informed consent.
Who cannot join
- The patient is:
- A prisoner
- Mentally incompetent or unable to understand what participation in the study entails
- A known alcohol or drug abuser
- Anticipated to be non-compliant
- The patient has a neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure or complications in postoperative care.
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- The patient has a neurologic condition in the ipsilateral or contralateral limb which affects lower limb function.
- The patient has a diagnosed systemic disease that could affect his/her safety or the study outcome.
- The patient is known to be pregnant.
- The patient is unwilling or unable to give consent or to comply with the follow-up program.
- The patient has received an investigational drug or device within the previous 6 months.
- The patient has an active or latent infection in or about the affected hip joint or an infection distant from the hip joint that may spread to the hip hematogenously.
- The patient has insufficient bone stock to fix the component. Insufficient bone stock exists in the presence of metabolic bone disease (i.e., osteoporosis), cancer, and radiation. Note: Dual Energy X-ray Absorptiometry (DEXA) may be used to assess the presence of adequate bone stock.
- The patient has osteoradionecrosis in the affected hip joint.
- The patient has a known sensitivity or allergic reaction to one or more of the implanted materials.
- The patient has known local bone tumors and/or cysts in the operative hip.
- The patient has a Body Mass Index (BMI) > 40.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Denver Health Medical Center
Denver, Colorado, 80204
Sah Orthopaedic Associates
Fremont, California, 94538
About this study
Official title: Prospective Post Market Clinical Follow-Up Study of the Continuum Metal on Polyethylene Acetabular System
This is a prospective, multi-center, non-randomized, non-controlled study designed to obtain survival and outcome data on the Continuum Metal on Polyethylene Acetabular System when used in primary total hip arthroplasty.
Read the detailed description
The safety and performance of the Continuum Metal on Polyethylene Acetabular System will be confirmed by the assessment of survival and outcome data. Assessments will include standard scoring systems, radiographs and adverse event records. Data will be used to monitor pain, mobility, and survivorship of the Continuum Metal on Polyethylene Acetabular system in primary total hip arthroplasty. Metal ion (cobalt, chromium and titanium) and renal function (BUN, Creatinine and GFR) levels will be analyzed for a subset of the enrolled study subjects.
- Conditions
- Avascular Necrosis, Osteoarthritis, Inflammatory Arthritis, Post-traumatic Arthritis, Rheumatoid Arthritis
- Being tested
- Continuum Metal on Polyethylene Acetabular System
- Keywords
- Total Hip Arthroplasty, Total Hip Replacement (THR), Primary Hip Arthroplasty, THA, THR
- Medical subject headings
- Osteonecrosis, Osteoarthritis, Arthritis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuum Metal on Polyethylene Acetabular SystemDevice
Also called Total Hip Replacement, Total Hip Arthroplasty, Primary Hip
Used in primary hip arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Continuum Acetabular System | Patients receiving primary hip arthroplasty using the Continuum Metal on Polyethylene Acetabular System Receives: Device: Continuum Metal on Polyethylene Acetabular System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship
Based on removal or intended removal of the device and determined using the Kaplan-Meier method.
Measured: 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
Safety / Adverse Events
Safety will be evaluated by monitoring the frequency and incidence of device related adverse events or unanticipated adverse device effects in investigational subjects.
Measured: Surgery, 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
Secondary outcomes (4)
Pain and Function / HHS
Pain and function will be measured using the Harris Hip Score self assessment.
Measured: 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
Pain and Function / OHS
Pain and function will be measured using the Oxford Hip Score self assessment.
Measured: 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
Health Status / SF-12
Health status will be measured using the SF-12 self assessment.
Measured: 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
Health Status / Radiographic Parameters
X-rays will be evaluated for acetabular cup angle, acetabular cup migration, femoral stem position, femoral stem subsidence and femoral stem shift.
Measured: 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study start29 Mar 2011
- Primary completion17 Jul 2026
- Study completion17 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Avascular NecrosisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hillary Overholser, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307384
- Sponsor's protocol ID
- CMU2010-02H
- Status last verified
- Sep 2026
- First submitted
- 25 Feb 2011
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Post Market Clinical Follow-Up Study of the Continuum Metal on Polyethylene Acetabular System
- ClinicalTrials.gov ID
- NCT01307384
- Acronym / sponsor ID
- CMU2010-02H
- Conditions
- Avascular Necrosis, Osteoarthritis, Inflammatory Arthritis, Post-traumatic Arthritis, Rheumatoid Arthritis
- Keywords
- Total Hip Arthroplasty, Total Hip Replacement (THR), Primary Hip Arthroplasty, THA, THR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2011 (actual)
- Primary completion
- 17 Jul 2026 (actual)
- Study completion
- 17 Jul 2026 (actual)
- First posted
- 2 Mar 2011 (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.
This is a prospective, multi-center, non-randomized, non-controlled study designed to obtain survival and outcome data on the Continuum Metal on Polyethylene Acetabular System when used in primary total hip arthroplasty.
Detailed description
The safety and performance of the Continuum Metal on Polyethylene Acetabular System will be confirmed by the assessment of survival and outcome data. Assessments will include standard scoring systems, radiographs and adverse event records. Data will be used to monitor pain, mobility, and survivorship of the Continuum Metal on Polyethylene Acetabular system in primary total hip arthroplasty. Metal ion (cobalt, chromium and titanium) and renal function (BUN, Creatinine and GFR) levels will be analyzed for a subset of the enrolled study subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuum Acetabular System | – | Device: Continuum Metal on Polyethylene Acetabular SystemPatients receiving primary hip arthroplasty using the Continuum Metal on Polyethylene Acetabular System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from surgeons medical practice who are candidates for primary hip arthroplasty. The study population will be comprised of 300 males and females who require primary total hip arthroplasty. Subjects will be enrolled at up to 7 clinical sites. Subjects must be geographically accessible throughout the study and be willing and able to attend required follow-up appointments. Candidates who express interest in study participation will be offered informed consent, and eligibility will be determined based upon the inclusion/exclusion criteria.
Key inclusion criteria (13 listed)
- Patient is 18 to 75 years of age, inclusive.
- Patient is skeletally mature.
- Patient qualifies for primary unilateral or bilateral (simultaneous or staged) total hip arthroplasty (THA) based on physical exam and medical history including the following:
- Patient has no history of previous prosthetic replacement device of any type, including surface replacement arthroplasty, endoprosthesis, etc. of the affected hip joint(s).
- Patient has moderate, marked or disabling pain.
Key exclusion criteria (17 listed)
- The patient is:
- The patient has a neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure or complications in postoperative care.
- The patient has a neurologic condition in the ipsilateral or contralateral limb which affects lower limb function.
- The patient has a diagnosed systemic disease that could affect his/her safety or the study outcome.
- The patient is known to be pregnant.
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 |
|---|---|---|
| Continuum Metal on Polyethylene Acetabular SystemAlso: Total Hip Replacement, Total Hip Arthroplasty, Primary HipUsed in primary hip arthroplasty | Device | Continuum Acetabular System |
Primary outcome
Survivorship
Time frame: 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
Based on removal or intended removal of the device and determined using the Kaplan-Meier method.
Safety / Adverse Events
Time frame: Surgery, 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
Safety will be evaluated by monitoring the frequency and incidence of device related adverse events or unanticipated adverse device effects in investigational subjects.
4 secondary outcomes
Pain and Function / HHS
Time frame: 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
Pain and Function / OHS
Time frame: 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
Health Status / SF-12
Time frame: 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
Health Status / Radiographic Parameters
Time frame: 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
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 29 Sep 2026.
- 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.
Hillary Overholser 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 Avascular Necrosis and Osteoarthritis, run by Zimmer Biomet 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 13 inclusion and 17 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 29 Sep 2026. 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?
Survivorship (time frame: 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year). The study lists 2 primary outcomes in all. 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 29 Sep 2026.