Clinical trial · Observational
MaxAn Post Market Surveillance Validation
A Post Market Surveillance Validation to Evaluate the Effectiveness of the MaxAn Anterior Cervical Plate
NCT01343693CI-TRIAL-00042602MaxAncompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DDD | — | UNRESOLVED | — |
| Deformity | — | UNRESOLVED | — |
| Fracture | — | UNRESOLVED | — |
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Anterior cervical discectomy and fusion
- description
- 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.
Primary outcomes (1)
- measure
- Number of Participants With Differing Severity of Adjacent Level Ossification
- timeFrame
- 24 Months
- description
- 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 (1)
- measure
- Change in Neck Disability Index (NDI)
- timeFrame
- 24 Months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.