Adjacent segment disease of the cervical spine, Cervical spine instability, Cervical spondylotic radiculopathy
Conditions
Interventions
Test group:Cervical inter - articular process fusion surgery using a customized 3D - printed metal cervical inter - articular process fusion device
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
25 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged between 25 and 75 years old; 2.Patients with surgical indications who are planned to undergo cervical facet joint fusion surgery; 3.Patients whose needs for clinical surgeries cannot be met by standardized products on the market or those with rare and special cases who require customized spinal implants; 4.Patients with no surgical contraindications in routine preoperative laboratory tests and examinations; 5.Those who have not participated in other clinical trials within the past three months; 6.Inpatients whose informed consent forms are signed by themselves or their family members;
Exclusion criteria
Exclusion criteria: 1.The patient has multiple metastases of the tumor, and the expected lifespan is less than one year; 2.People with severe organ damage; 3.Suffer from mental illnesses; 4.Pregnant and breastfeeding women; 5.Subjects who are currently participating in other clinical trials or have participated in other clinical trials within the past three months; 6.Subjects cannot comply with follow - up or affect the scientific integrity of the study; 7.Other individuals deemed ineligible for enrollment by clinical doctors' evaluation;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fusion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Stability of internal implants, changes in overall curvature, and curvature of the fused segments;Visual Analogue Scale score, Japanese Orthopaedic Association Scores , Oswestry Disability Index ; | — |
Countries
China
Contacts
Public ContactYuan Feng
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed