Cervical Vertebral Fusion, Spinal Fusion
Conditions
Keywords
Cervical vertebrae, Postoperative complications, Radiography, Spinal fusion, Coating
Brief summary
Prospective Follow-up study of CeSPACE XP coated PEEK cages for the treatment of degenerative cervical disc disease
Detailed description
Anterior cervical discectomy and fusion (ACDF) has been accepted as the standard procedure for the treatment of myelopathy and radiculopathy in the cervical spine. A tricortical iliac crest bone graft is the traditional inter-body fusion material that can show perfect bony fusion and maintain the patency of the neuroforamen. However, donor site complications were reported in fusion with an iliac bone graft, such as subcutaneous hematomas, infections, and chronic wound pain. Currently, the titanium cage and polyetheretherketone (PEEK) cage are the two most common cages in clinical practice. The ideal cage should lead to a high fusion rate and prevent complications, such as subsidence and loss of correction. Even though a titanium cage can provide long-term stabilization, increase lordosis, and increase foramina height compared with the iliac bone graft, some inferior clinical outcomes appeared in clinical practice. Loss of correction is a major complication of subsidence that may eventually affect cervical spinal function after the operation. A modulus of elasticity close to cortical bone might contribute to advantages in stress distribution and load sharing, which can contribute to a lower subsidence rate and, thus, better clinical results, making PEEK cages more welcomed by surgeons. It is supposed, that in the cervical fusion procedure, a porous coating of a PEEK cage will lead to favourable results. Therefore, the present study intends to show these results, in a larger patient cohort who received such a coated cervical cage.
Interventions
None listed
Sponsors
Aesculap AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All consecutive patients who received a CeSPACE XP cage between August 2013 and January 2017
Exclusion criteria
* Pregnancy * Patient consent not signed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neck Disability Index (NDI) during Follow-Up | Once between 1 to 4 years postoperative | The Neck Disability Index(NDI) is a modification of the Oswestry Low Back Pain Disability Index . It 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. The NDI has sufficient support and usefulness to retain its current status as the most commonly used self-report measure for neck pain. The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. All the points can be summed to a total score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction at Follow-Up | Once between 1 to 4 years postoperative | Patient self-reported satisfaction measured by a four-level scale: excellent, good, not satisfied, bad |
| Neck Pain at Follow-Up | Once between 1 to 4 years postoperative | Patient self-reported Neck Pain measured by Visual Analogue Scale (VAS). The VAS is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. |
| Arm Pain during Follow-Up | Once between 1 to 4 years postoperative | Patient self-reported Arm Pain measured by Visual Analogue Scale (VAS). The VAS is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. |
| Neurological Outcome at Follow-Up | 1 to 4 years follow-up | Current neurological assessment at follow-up, measured by a four-level scale: no deficit, sensory deficit, motor deficit, sensory & motor deficit |
| Radiographic Evaluation of Mobility at Follow-Up | Once between 1 to 4 years postoperative | Radiological evaluation: Fusion criteria 1: Degree of Flexion, Degree of Extension, Mobility (Extension-Flexion) |
| Radiographic Evaluation of Bone Bridges at Follow-Up | Once between 1 to 4 years postoperative | Radiological evaluation: Fusion criteria 2: no bone bridges between adjacent vertebral bodies, Radiological densities visible compared to directly postop state, Bone Bridges linking adjacent vertebral bodies (anterior / posterior) |
| Radiographic Evaluation of Radiolucencies at Follow-Up | Once between 1 to 4 years postoperative | Radiological evaluation: Fusion criteria 3: no radiolucent line along the implant end plate (0%), mild / under 25% radiolucencies, moderate / 25-50% radiolucencies, severe / more than 50% radiolucencies |
| Work Status at Follow-Up | Once between 1 to 4 years postoperative | current profession and working level |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of Patients with Adverse Events and Serious Adverse Events during Follow-up | Up to 4 years postoperative | Number of Patients who had potential reoperations and revisions |
Countries
Spain
Outcome results
None listed