Cervical Radiculopathy, Cervical Spondylotic Myelopathy, Lumbar Disk Herniation, Lumbar Spinal Stenosis, Lumbar Spondylolisthesis
Conditions
Keywords
Enhanced recovery after surgery (ERAS), Spinal fusion surgery, Advanced age patient, High risk factors
Brief summary
To determine the high risk factors affecting accelerated recovery after spinal fusion surgery in advanced age patient.
Detailed description
To determine the high risk factors affecting accelerated recovery after spinal fusion surgery in elderly patients: a prospective cohort study
Interventions
DIAGNOSTIC_TESTThis is an observational study
This study divides the elderly population into two groups: the Elderly group and the Advanced age group. By observing the enhanced recovery after spinal fusion surgery in these two distinct age groups of elderly patients, risk factors affecting postoperative enhanced recovery will be identified. Detection index: Blood routine examination, blood biochemistry, coagulation function, imaging examination (X-ray, CT 3D reconstruction), Japanese Orthopaedic Association (JOA) score, visual analogue scale (VAS) pain score. The number of participants for all adverse events, serious adverse events, implant-related adverse events and drug-related serious adverse events, and the adverse events were summarized accordingly. The severity of adverse events will be rated according to NCI-CTCAE version 4.0.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Informed consent signed and dated by subject or guardian 2. Commit to follow the research procedures and cooperate with the whole process of the study 3. The subjects are 60 years old or older, regardless of gender 4. Patients with degenerative spinal diseases requiring spinal fusion surgery 5. Generally in good physical condition 6. Able to adhere to and cooperate with research interventions, such as oral medication 7. In fertile women, contraception should be used for at least one month prior to screening, and they should commit to use contraception throughout the study period and continue until the specified time after the study
Exclusion criteria
1. Acute infection 2. Congenital malformation 3. Abnormal anatomy or skeletal variation 4. Malignant tumor 5. The surgical area was locally infected with symptoms of local inflammation 6. Fever or leukocytosis 7. Morbid obesity 8. Pregnant and nursing women 9. Mental illness 10. Acute joint disease, bone resorption, osteopenia and/or osteoporosis. Osteoporosis is a relative contraindication, as this condition may limit the degree of correction that can be produced, the amount of mechanical fixation, and/or the quality of the bone graft 11. Patients who are unwilling to cooperate with post-operative treatment 12. Any time an implant is performed it interferes with the anatomy or intended physiological function of the patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Metrics for Enhanced Recovery After Spinal Fusion Surgery | Baseline. 7 days, 3 months, 6 months, 9 months and 12 months after surgery | Blood routine examination, blood biochemistry, coagulation function, imaging examination (X-ray, CT 3D reconstruction). The number of participants for all adverse events, serious adverse events, implant-related adverse events and drug-related serious adverse events, and the adverse events were summarized accordingly. The severity of adverse events will be rated according to NCI-CTCAE version 4.0. |
Countries
China
Outcome results
None listed