MaxAn Post Market Surveillance Validati… | Clinical Trial

Key information

Conditions

DDD Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deformity Fracture Fractures, Bone Neoplasms Tumor Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Montgomery Spine Center, Montgomery, Alabama, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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)

Secondary outcomes

Change in Neck Disability Index (NDI)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

A Post Market Surveillance Validation to Evaluate the Effectiveness of the MaxAn Anterior Cervical Plate

Acronym: MaxAn

Important dates

Study start: 2011
Primary completion: 2018
Study completion: 2018
First posted: Apr 28, 2011
Registry last updated: Jan 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed