MaxAn Post Market Surveillance Validation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

119 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2018-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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DDD Deformity Tumor Fracture

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No