Clinical trial NCT06591442: Screening and Prospective Cohort Study of Risk Factors for Enhanced Recovery After Spinal Fusion Surgery in Advanced Age Patient
Official title: Screening and Prospective Cohort Study of Risk Factors for Enhanced Recovery After Spinal Fusion Surgery in Advanced Age Patient
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Lumbar Disk Herniation
Lumbar Spinal Stenosis
Lumbar Spondylolisthesis
Cervical Spondylotic Myelopathy
Cervical Radiculopathy
Keywords: Enhanced recovery after surgery (ERAS)
Spinal fusion surgery
Advanced age patient
High risk factors
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 500
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Department of Orthopedics, Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, China

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

Eligibility criteria: 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

Primary outcomes:
measure: Safety Metrics for Enhanced Recovery After Spinal Fusion Surgery
timeFrame: Baseline. 7 days, 3 months, 6 months, 9 months and 12 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Orthopedics, Affiliated Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430023
state: Hubei
Study officials:
References: