cervical herniated disc
Conditions
Interventions
Anterior cervical discectomy with interbody fusion by implantation of 3-D
trabecular titanium cage (EIT Cellular Titanium®).
Sponsors
neurochirurgie
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Age 18 75 years. * Radicular signs and symptoms in one or both arms (i.e., pain, paraesthesiae or paresis in a specific nerve root distribution) or symptoms and signs of myelopathy. * At least 8 weeks prior conservative treatment (i.e., physical therapy, pain medication). * Radiographic diagnosis of cervical disc herniation and/or osteophyte at 1 level (C3-C4 to C7-T1) in accordance with clinical signs and symptoms. * Written informed consent.
Exclusion criteria
Exclusion criteria: * Previous cervical surgery (either anterior or posterior) * Increased motion on dynamic studies (> 3 mm) * Neck pain only (without radicular or medullary symptoms) * Infection * Osteoporosis * Neoplasma or trauma of the cervical spine * Spinal anomaly (Klippel Feil, Bechterew, OPLL) * Severe mental or psychiatric disorder * Inadequate Dutch language * Planned (e)migration abroad in the year after inclusion . Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is improvement in the Neck and Disability Index (NDI) one year after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measure is the temporal evaluation of bony fusion using dynamic lateral flexion-extension radiographs that will be quantitatively analysed. Other outcome measures include improvement in arm pain and neck pain (VAS), EuroQol-5D, patients' perceived recovery, and perioperative variables including operating time, blood loss, length of hospital stay, and adverse events. | — |
Countries
Netherlands
Outcome results
None listed