MaxAn Post Market Surveillance Validation

NCT01343693 | Completed Results

• 1 other identifier: CS-059
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 6

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.

Conditions

DDD; Deformity; Tumor; Fracture

Keywords

DDD; Deformity; Tumor; Fracture; Cervical

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Neck Disability Index (NDI)

  24 Months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This post market surveillance study will enroll two hundred (200) subjects across 10 clinical centers within the United States with subjects followed for 24 months post-surgery. All subjects enrolled in the study will be recruited from the pool of subjects presenting to each investigational site for an anterior cervical fusion procedure. The 10 surgeons chosen to participate in this study will be thoroughly knowledgeable in the medical, surgical and mechanical aspects of the MaxAn® Anterior Cervical Plate System. The following inclusion and exclusion criteria must be met for a patient to be considered eligible for participation in this study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (6)

Montgomery Spine Center

Montgomery, Alabama, 36116, United States

Location

Tallahassee Neurological Clinic

Tallahassee, Florida, 32308, United States

Location

Community Neurosurgery

Indianapolis, Indiana, 46219, United States

Location

Maryland Spine and Brain

Annapolis, Maryland, 21401, United States

Location

Cary Orthopedics

Cary, North Carolina, 27518, United States

Location

DFW Center for Spinal Disorders

Fort Worth, Texas, 76107, United States

Location

MeSH Terms

Conditions

Congenital Abnormalities; Neoplasms; Fractures, Bone

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Wounds and Injuries

Results Point of Contact

• Title: Zimmer Biomet Spine Clinical Affairs
• Organization: Zimmer Biomet Spine

spinemedinfo@zimmerbiomet.com

303-501-8571

Study Officials

• Gary Dix, MD

  Maryland Spine and Brain

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2011
• First Posted: April 28, 2011
• Study Start: June 1, 2011
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: January 6, 2020
• Results First Posted: January 6, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)