Degenerative cervical myelopathy and/or radiculopathy (primarily including cervical spondylotic radiculopathy, cervical spondylotic amyotrophy, cervical spondylotic myelopathy, cervical ossification of the posterior longitudinal ligament, and cervical disc herniation).
Conditions
Interventions
Group A (cervical collar group): After one- or two-level ACDF using ROI-C, patients will wear a standard Philadelphia cervical collar for 6 weeks postoperatively. ROI-C manufactured by Highridge Medic
Sponsors
Japan Community Healthcare Organization Osaka Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients scheduled to undergo elective anterior cervical discectomy and fusion (ACDF) using ROI-C at our institution 2. Age >=20 years 3. Patients with one- or two-level degenerative cervical myelopathy and/or cervical radiculopathy (mainly cervical spondylotic radiculopathy, cervical spondylotic amyotrophy, cervical spondylotic myelopathy, ossification of the posterior longitudinal ligament, cervical disc herniation, etc.) who are deemed suitable for anterior cervical fusion 4. Patients who have provided written informed consent
Exclusion criteria
Exclusion criteria: 1. Revision surgery cases 2. Patients whose primary pathology is non-degenerative disease, such as infection, tumor, or trauma 3. Fusion involving three or more levels 4. Patients judged unsuitable for study participation by the operating surgeon because of poor bone quality or other clinical reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Neck Disability Index (NDI) at 6 weeks after anterior cervical fusion using ROI-C will be compared between the cervical collar group and the non-collar group. A standard Philadelphia cervical collar will be used for postoperative immobilization. The NDI is scored on a scale from 0 to 50, with higher scores indicating greater neck-related functional disability. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in the Neck Disability Index (NDI) preoperatively and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months postoperatively 2. Neck pain visual analog scale (VAS; average pain during the previous 7 days, 0-100 mm) measured preoperatively and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months postoperatively 3. Japanese Orthopaedic Association (JOA) score, Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ), EQ-5D, SF-8, and patient satisfaction measured preoperatively and at 3 months, 6 months, and 12 months postoperatively 4. Radiographic parameters including C2-7 lordotic angle, T1 slope, C2-7 sagittal vertical axis (C2-7 SVA), and C2-7 range of motion (C2-7 ROM) 5. Cage subsidence (change in intervertebral height from immediately after surgery to 3 and 6 months postoperatively) 6. Fusion status at 12 months evaluated using plain radiographs and/or computed tomography 7. Wound findings and wound-related complications, including surgical site infection (SSI), hematoma, seroma, wound dehiscence, and reoperation 8. Dysphagia, hoarseness, collar-related skin problems (redness, pressure marks, pressure ulcer), collar-related discomfort, and other adverse events | — |
Countries
Japan
Contacts
Public ContactShota Takenaka
Japan Community Healthcare Organization Osaka Hospital Department of orthopaedic surgery
Outcome results
None listed