N/A
N=119
MaxAn Post Market Surveillance Validation
DDD · Deformity · Tumor · Fracture
Bottom Line
View on ClinicalTrials.gov: NCT01343693 ↗Enrolled (actual)
119
Serious AEs
11.8%
Results posted
Jan 2020
Primary outcome: Primary: Number of Participants With Differing Severity of Adjacent Level Ossification — 36; 38; 16; 10 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zimmer Biomet
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Differing Severity of Adjacent Level Ossification |
36; 38; 16; 10; 2; 8 | — |
| SECONDARY Change in Neck Disability Index (NDI) |
22.0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01343693). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.