Cervical spondylosis
Conditions
Interventions
Group A:The trialing phase of the artificial disc replacement procedure was completed under maintained distraction with Caspar retractors to preserve intervertebral height, followed by implantation of
Group B:The trialing phase of the artificial disc replacement procedure was completed under maintained distraction without Caspar retractors to preserve intervertebral height, followed by implantation
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients with radiculopathy or myelopathy attributable to single- or multi-level cervical disc disease, confirmed by supportive magnetic resonance imaging (MRI) findings, who have failed evidence-based conservative management or exhibit progressive neurological deterioration impacting activities of daily living and occupation, and thus requiring anterior decompressive surgery (including hybrid procedures incorporating artificial cervical disc arthroplasty). 2. Patients aged >18 years with surgical levels confined to C3–C7. 3. Patients with comprehensively documented intraoperative (anteroposterior and lateral) and postoperative (anteroposterior, lateral, and flexion-extension) radiographic studies and complete clinical records. 4.Patients deemed medically and psychologically fit to fully comply with the protocol, adhere to scheduled treatments, complete all required documentation, and participate in follow-up assessments for 6 months. 5.Provision of written informed consent specifically acknowledging understanding and acceptance of the study procedures.
Exclusion criteria
Exclusion criteria: 1. History of prior cervical spine surgery, adjacent-segment ankylosis, esophageal pathology, revision surgery, or anterior cervical procedures. 2.Active psychiatric disorders (e.g., mania, major depression), traumatic brain injury, or central nervous system diseases (e.g., stroke). 3.Cervical trauma, severe facet joint degeneration, ossification of the posterior longitudinal ligament (OPLL), segmental range of motion (ROM) 3 mm translation), >50% disc height loss, or osteoporosis (T-score < -2.5). 4. Active cervical skin infection/ulceration, spinal pathological fractures, spinal deformity, OPLL, rheumatoid arthritis, ankylosing spondylitis, developmental spinal stenosis, or local/systemic infection. Severe systemic comorbidities contraindicating surgery or compromised cardiorespiratory reserve precluding safe anesthesia. 5.Current pregnancy or planned pregnancy during the study period. 6.Concurrent enrollment in another clinical trial potentially confounding study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative Plate-Bone Interface Gap Height;Trial-Prosthesis Height Differential;Trial Implant Exchange Count;Trial Implant Height Adjustment Frequency;Range of Motion (ROM);Implant-Related Complications(Subsidence Migration);Incidence of Postoperative Heterotopic Ossification and Anterior Vertebral Bone Loss;Dysphagia;Patient Satisfaction Survey (PSS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative Technical Difficulty Rating;Japanese Orthopaedic Association (JOA) Neck Disability Index (NDI) Visual Analog Scale (VAS); | — |
Countries
China
Contacts
Public ContactWang beiyu
West China Hospital of Sichuan University
Outcome results
None listed