MaxAn Post Market Surveillance Validation

Tumor Clinical Trial

— MaxAn  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01343693
• Other study ID #: CS-059
• Status: Completed
• Start date: June 2011
• Est. completion date: January 2018

Study information

• Verified date: December 2019
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• DDD
• Deformity
• Fracture
• Tumor

Locations

Country	Name	City	State
United States	Maryland Spine and Brain	Annapolis	Maryland
United States	Cary Orthopedics	Cary	North Carolina
United States	DFW Center for Spinal Disorders	Fort Worth	Texas
United States	Community Neurosurgery	Indianapolis	Indiana
United States	Montgomery Spine Center	Montgomery	Alabama
United States	Tallahassee Neurological Clinic	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	24 Months
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.	24 Months