Screening and Prospective Cohort Study of Risk Factors for Enhanced Recovery After Spinal Fusion Surgery in Advanced Age Patient

Huazhong University of Science and Technology

Status: Invitation-only

Conditions: Cervical Spondylotic Myelopathy; Lumbar Spondylolisthesis; Lumbar Spinal Stenosis; Cervical Radiculopathy; Lumbar Disk Herniation

Treatments: Diagnostic Test: This is an observational study

Study type: Observational

Funder types: Other

Identifiers

NCT06591442

UHCT-IEC-SOP-016-03-01-2024-1

2024(0735) (Other Identifier)

Details and patient eligibility

About

To determine the high risk factors affecting accelerated recovery after spinal fusion surgery in advanced age patient.

Full description

To determine the high risk factors affecting accelerated recovery after spinal fusion surgery in elderly patients: a prospective cohort study

Enrollment: 500 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 2 patient groups

Elderly group patients (60-74 years).

Treatment:

Diagnostic Test: This is an observational study

Advanced age group patients (≥75 years)

Treatment:

Diagnostic Test: This is an observational study