DDD, Deformity, Fracture, Tumor
Conditions
Keywords
DDD, Deformity, Tumor, Fracture, Cervical
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.
Interventions
None listed
Sponsors
Zimmer Biomet
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ACDF With MaxAn Plate 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. | 119 |
| Total | 119 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 9 |
Baseline characteristics
| Characteristic | ACDF With MaxAn Plate | — |
|---|---|---|
| Age, Continuous | 54.3 years | — |
| BMI (kg/m^2) | 29.8 kg/m^2 STANDARD_DEVIATION 5.5 | — |
| Employment Status Currently Working | 50 Participants | — |
| Employment Status Disabled/Retired Due to Ill Health | 28 Participants | — |
| Employment Status Not Reported | 8 Participants | — |
| Employment Status Retired | 23 Participants | — |
| Employment Status Unemployed | 7 Participants | — |
| Employment Status Workers Compensation | 3 Participants | — |
| Number of Operated Levels One vertebral level | 27 Participants | — |
| Number of Operated Levels Three vertebral levels | 23 Participants | — |
| Number of Operated Levels Two vertebral levels | 69 Participants | — |
| Previous Cervical Spine Surgery No | 95 Participants | — |
| Previous Cervical Spine Surgery Yes | 24 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 119 participants | — |
| Sex: Female, Male Female | 66 Participants | — |
| Sex: Female, Male Male | 53 Participants | — |
| Tobacco Use Current | 37 Participants | — |
| Tobacco Use Never | 52 Participants | — |
| Tobacco Use Past | 30 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 119 |
| other Total, other adverse events | 83 / 119 |
| serious Total, serious adverse events | 14 / 119 |
Outcome results
Primary
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)
Time frame: 24 Months
Population: 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 | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ACDF With MaxAn Plate | Number of Participants With Differing Severity of Adjacent Level Ossification | Grade 0 | 36 Participants |
| ACDF With MaxAn Plate | Number of Participants With Differing Severity of Adjacent Level Ossification | Grade 1 | 38 Participants |
| ACDF With MaxAn Plate | Number of Participants With Differing Severity of Adjacent Level Ossification | Grade 2 | 16 Participants |
| ACDF With MaxAn Plate | Number of Participants With Differing Severity of Adjacent Level Ossification | Grade 3 | 10 Participants |
| ACDF With MaxAn Plate | Number of Participants With Differing Severity of Adjacent Level Ossification | Unable to Assess | 2 Participants |
| ACDF With MaxAn Plate | Number of Participants With Differing Severity of Adjacent Level Ossification | Missing Radiographs | 8 Participants |
Secondary
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.
Time frame: 24 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ACDF With MaxAn Plate | Change in Neck Disability Index (NDI) | 22.0 score on a scale | Standard Deviation 20 |