MaxAn Post Market Surveillance Validation
Study Details
Study Description
Brief 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.
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Outcome Measures
Primary Outcome Measures
- Number of Participants With Differing Severity of Adjacent Level Ossification [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)
Secondary Outcome Measures
- Change in Neck Disability Index (NDI) [24 Months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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.
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Montgomery Spine Center | Montgomery | Alabama | United States | 36116 |
| 2 | Tallahassee Neurological Clinic | Tallahassee | Florida | United States | 32308 |
| 3 | Community Neurosurgery | Indianapolis | Indiana | United States | 46219 |
| 4 | Maryland Spine and Brain | Annapolis | Maryland | United States | 21401 |
| 5 | Cary Orthopedics | Cary | North Carolina | United States | 27518 |
| 6 | DFW Center for Spinal Disorders | Fort Worth | Texas | United States | 76107 |
Sponsors and Collaborators
- Zimmer Biomet
Investigators
- Principal Investigator: Gary Dix, MD, Maryland Spine and Brain
Study Documents (Full-Text)
More Information
Publications
None provided.- CS-059
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | ACDF With MaxAn Plate |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 119 |
| COMPLETED | 110 |
| NOT COMPLETED | 9 |
Baseline Characteristics
| Arm/Group Title | ACDF With MaxAn Plate |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 119 |
| Age (years) [Mean (Full Range) ] | |
| Mean (Full Range) [years] |
54.3
|
| Sex: Female, Male (Count of Participants) | |
| Female |
66
55.5%
|
| Male |
53
44.5%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
| Region of Enrollment (participants) [Number] | |
| United States |
119
100%
|
| BMI (kg/m^2) (kg/m^2) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [kg/m^2] |
29.8
(5.5)
|
| Employment Status (Count of Participants) | |
| Currently Working |
50
42%
|
| Disabled/Retired Due to Ill Health |
28
23.5%
|
| Retired |
23
19.3%
|
| Unemployed |
7
5.9%
|
| Workers Compensation |
3
2.5%
|
| Not Reported |
8
6.7%
|
| Tobacco Use (Count of Participants) | |
| Current |
37
31.1%
|
| Past |
30
25.2%
|
| Never |
52
43.7%
|
| Previous Cervical Spine Surgery (Count of Participants) | |
| Yes |
24
20.2%
|
| No |
95
79.8%
|
| Number of Operated Levels (Count of Participants) | |
| One vertebral level |
27
22.7%
|
| Two vertebral levels |
69
58%
|
| Three vertebral levels |
23
19.3%
|
Outcome Measures
| Title | Number of Participants With Differing Severity of Adjacent Level Ossification |
|---|---|
| Description | 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) |
| Time Frame | 24 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Ten of the 110 patients with 24 month follow up were not evaluated for this endpoint. Eight had missing radiographs and 2 had unevaluable radiographs. |
| Arm/Group Title | ACDF With MaxAn Plate |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 110 |
| Grade 0 |
36
30.3%
|
| Grade 1 |
38
31.9%
|
| Grade 2 |
16
13.4%
|
| Grade 3 |
10
8.4%
|
| Unable to Assess |
2
1.7%
|
| Missing Radiographs |
8
6.7%
|
| Title | Change in Neck Disability Index (NDI) |
|---|---|
| Description | 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. |
| Time Frame | 24 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | ACDF With MaxAn Plate |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 110 |
| Mean (Standard Deviation) [score on a scale] |
22.0
(20.0)
|
Adverse Events
| Time Frame | 24 Months | |
|---|---|---|
| Adverse Event Reporting Description | All adverse events, including both observed or volunteered problems, complaints, symptoms, physical signs or disease which either occur during the study, having been absent at baseline, or, if present at baseline, appear to worsen during the clinical outcomes collection study were recorded as part of the study. | |
| Arm/Group Title | ACDF With MaxAn Plate | |
| Arm/Group Description | 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. | |
All Cause Mortality |
||
| ACDF With MaxAn Plate | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/119 (0%) | |
Serious Adverse Events |
||
| ACDF With MaxAn Plate | ||
| Affected / at Risk (%) | # Events | |
| Total | 14/119 (11.8%) | |
| Musculoskeletal and connective tissue disorders | ||
| Neck pain | 14/119 (11.8%) | 16 |
Other (Not Including Serious) Adverse Events |
||
| ACDF With MaxAn Plate | ||
| Affected / at Risk (%) | # Events | |
| Total | 83/119 (69.7%) | |
| Gastrointestinal disorders | ||
| Dysphagia | 9/119 (7.6%) | 9 |
| Abdominal pain | 2/119 (1.7%) | 2 |
| Injury, poisoning and procedural complications | ||
| Wound complication | 4/119 (3.4%) | 4 |
| Procedural complication, other | 2/119 (1.7%) | 2 |
| Procedural complication other | 1/119 (0.8%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Musculoskeletal Other - Pseudoarthrosis | 20/119 (16.8%) | 20 |
| Musculoskeletal other - Degenerative disc disease | 15/119 (12.6%) | 15 |
| Neck Pain | 14/119 (11.8%) | 14 |
| Arthralgia | 6/119 (5%) | 6 |
| Radiculitis | 7/119 (5.9%) | 7 |
| Musculoskeletal other | 3/119 (2.5%) | 3 |
| Back pain | 2/119 (1.7%) | 2 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Radiculitis | 13/119 (10.9%) | 13 |
| Nervous system disorders | ||
| Paresthesia | 8/119 (6.7%) | 8 |
| Headache | 6/119 (5%) | 6 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Zimmer Biomet Spine Clinical Affairs |
|---|---|
| Organization | Zimmer Biomet Spine |
| Phone | 303-501-8571 |
| spinemedinfo@zimmerbiomet.com |
- CS-059