DDDMaxAnNCT01343693
MaxAn Post Market Surveillance Validation
An observational study of DDD and Deformity, run by Zimmer Biomet at 6 sites in United States.
Trial summary
This study is being performed to document the outcomes of subjects using our MaxAn Anterior Cervical Plate and assess them for Adjacent level Disease. All subjects will be followed for 2 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 119 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2011to Jan 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: This post market surveillance study will enroll two hundred (200) subjects across 10 clinical centers within the United States with subjects followed for 24 months post-surgery. All subjects enrolled in the study will be recruited from the pool of subjects presenting to each investigational site for an anterior cervical fusion procedure. The 10 surgeons chosen to participate in this study will be thoroughly knowledgeable in the medical, surgical and mechanical aspects of the MaxAn® Anterior Cervical Plate System. The following inclusion and exclusion criteria must be met for a patient to be considered eligible for participation in this study.
Who may be able to join
- Subject is scheduled to undergo a one to three-level primary spinal fusion surgery between the levels of C2-T1 (Cervical 2 to Thoracic 1) using the MaxAn® Anterior Cervical Plate System.
- Subject has agreed to participate in this study, sign the informed consent and have agreed to return for the 6, 12 and 24 month follow-up visits.
- Subjects or their representative must be willing and able to give informed consent.
Who cannot join
- Subject has spinal infection or inflammation at any level.
- Subject is morbidly obese, defined as a BMI greater than 40.
- Subject has a mental illness, alcoholism or drug abuse.
- Subject has a metal sensitivity/foreign body sensitivity.
- Subject has inadequate tissue coverage over the operative site.
- Subject has an open wound local to the operative area, or rapid joint disease, bone absorption, osteopenia and/or osteoporosis.
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- Female subjects who are pregnant or plan to become pregnant in the next 24 months or who are lactating.
- Subject who does not meet the specific indications for use of the MaxAn® Anterior Cervical Plate System.
- Subjects participating in another clinical research study.
- Any previous cervical spinal surgery.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Maryland Spine and Brain
Annapolis, Maryland, 21401
Cary Orthopedics
Cary, North Carolina, 27518
DFW Center for Spinal Disorders
Fort Worth, Texas, 76107
Community Neurosurgery
Indianapolis, Indiana, 46219
Montgomery Spine Center
Montgomery, Alabama, 36116
Tallahassee Neurological Clinic
Tallahassee, Florida, 32308
About this study
Official title: A Post Market Surveillance Validation to Evaluate the Effectiveness of the MaxAn Anterior Cervical Plate
This study is being performed to document the outcomes of subjects using our MaxAn Anterior Cervical Plate and assess them for Adjacent level Disease. All subjects will be followed for 2 years.
Read the detailed description
The purpose of this Post Market Surveillance Validation is to document the performance and clinical outcomes of the MaxAn® Anterior Cervical Plate System. Dr. Park, et.al conducted a retrospective review and found a positive association between adjacent-level ossification following anterior cervical plate procedures and the plate-to-disc distance. 1 They concluded that when the anterior cervical plates were placed at least 5mm away from the adjacent disc spaces, there was a decrease in the likelihood of moderate-to-severe adjacent-level ossification. The design of the MaxAn Anterior Cervical Plate and accompanying technique allows this type of plate placement; therefore we will be looking at the radiographic outcomes of these subjects and comparing them to the retrospective chart review conducted by Dr. Park using the MaxAn Technique allows you to achieve plate placement of 5mm from the supraadjacent level which will help minimize the risk of adjacent level ossification.
- Keywords
- DDD, Deformity, Tumor, Fracture, Cervical
- Medical subject headings
- Congenital Abnormalities, Neoplasms, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anterior cervical discectomy and fusion | Any subject with DDD, tumor, deformity ot trauma to the cervical spine in which the investigator determines the subject will require an ACDF using the MaxAn Plate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Differing Severity of Adjacent Level Ossification
Qualitatively assessed by an independent Radiologist using lateral radiographs Grade 0 - None Grade 1 - Mild (if the ossification extended across <50% of the disc space) Grade 2 - Moderate (if the ossification extended across ≥ 50% of the disc space) Grade 3 - Severe (if there is complete bridging of the adjacent disc space)
Measured: 24 Months
Secondary outcomes (1)
Change in Neck Disability Index (NDI)
The Neck Disability Index (NDI) is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain', with the points summed to a total score. The test can be interpretated as a raw score, with a minimum score of 0 and a maximum score of 50. A higher score indicates more patient-rated disability. To use the NDI for patient decisions, a clinically important change was calculated as 5 points.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startJun 2011
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DDDStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary Dix, MD, Principal investigator, Maryland Spine and Brain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343693
- Sponsor's protocol ID
- CS-059
- Acronym
- MaxAn
- Status last verified
- Dec 2019
- First submitted
- 27 Apr 2011
- Last updated
- 6 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Market Surveillance Validation to Evaluate the Effectiveness of the MaxAn Anterior Cervical Plate
- ClinicalTrials.gov ID
- NCT01343693
- Acronym / sponsor ID
- MaxAn / CS-059
- Keywords
- DDD, Deformity, Tumor, Fracture, Cervical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 28 Apr 2011 (estimated)
- Results
- Posted 6 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being performed to document the outcomes of subjects using our MaxAn Anterior Cervical Plate and assess them for Adjacent level Disease. All subjects will be followed for 2 years.
Detailed description
The purpose of this Post Market Surveillance Validation is to document the performance and clinical outcomes of the MaxAn® Anterior Cervical Plate System. Dr. Park, et.al conducted a retrospective review and found a positive association between adjacent-level ossification following anterior cervical plate procedures and the plate-to-disc distance. 1 They concluded that when the anterior cervical plates were placed at least 5mm away from the adjacent disc spaces, there was a decrease in the likelihood of moderate-to-severe adjacent-level ossification. The design of the MaxAn Anterior Cervical Plate and accompanying technique allows this type of plate placement; therefore we will be looking at the radiographic outcomes of these subjects and comparing them to the retrospective chart review conducted by Dr. Park using the MaxAn Technique allows you to achieve plate placement of 5mm from the supraadjacent level which will help minimize the risk of adjacent level ossification.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anterior cervical discectomy and fusion | – | –Any subject with DDD, tumor, deformity ot trauma to the cervical spine in which the investigator determines the subject will require an ACDF using the MaxAn Plate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This post market surveillance study will enroll two hundred (200) subjects across 10 clinical centers within the United States with subjects followed for 24 months post-surgery. All subjects enrolled in the study will be recruited from the pool of subjects presenting to each investigational site for an anterior cervical fusion procedure. The 10 surgeons chosen to participate in this study will be thoroughly knowledgeable in the medical, surgical and mechanical aspects of the MaxAn® Anterior Cervical Plate System. The following inclusion and exclusion criteria must be met for a patient to be considered eligible for participation in this study.
Key inclusion criteria (3 listed)
- Subject is scheduled to undergo a one to three-level primary spinal fusion surgery between the levels of C2-T1 (Cervical 2 to Thoracic 1) using the MaxAn® Anterior Cervical Plate System.
- Subject has agreed to participate in this study, sign the informed consent and have agreed to return for the 6, 12 and 24 month follow-up visits.
- Subjects or their representative must be willing and able to give informed consent.
Key exclusion criteria (10 listed)
- Subject has spinal infection or inflammation at any level.
- Subject is morbidly obese, defined as a BMI greater than 40.
- Subject has a mental illness, alcoholism or drug abuse.
- Subject has a metal sensitivity/foreign body sensitivity.
- Subject has inadequate tissue coverage over the operative site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Differing Severity of Adjacent Level Ossification
Time frame: 24 Months
Qualitatively assessed by an independent Radiologist using lateral radiographs Grade 0 - None Grade 1 - Mild (if the ossification extended across <50% of the disc space) Grade 2 - Moderate (if the ossification extended across ≥ 50% of the disc space) Grade 3 - Severe (if there is complete bridging of the adjacent disc space)
1 secondary outcome
Change in Neck Disability Index (NDI)
Time frame: 24 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Gary Dix, MD principal investigator
Maryland Spine and Brain
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of DDD and Deformity, run by Zimmer Biomet 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 3 inclusion and 10 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 6 Jan 2020. 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?
Yes. Results are posted in the registry (first posted 6 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Differing Severity of Adjacent Level Ossification (time frame: 24 Months). 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 6 Jan 2020.