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

• Conditions: Lumbar Disk Herniation; Lumbar Spinal Stenosis; Lumbar Spondylolisthesis; Cervical Spondylotic Myelopathy; Cervical Radiculopathy
• Interventions: Diagnostic Test: This is an observational study

• Registration Number: NCT06591442
• Lead Sponsor: Wuhan Union Hospital, 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

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-03
• Study First Submitted: 2024-09-07
• Study First Submitted QC: 2024-09-07
• Last Update Submitted: 2024-09-07
• Study First Posted: 2024-09-11
• Last Update Posted: 2024-09-11
• Primary Completion: 2027-09-03
• Study Completion: 2027-09-03

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Elderly group patients (60-74 years).	This is an observational study	-
Advanced age group patients (≥75 years)	This is an observational study	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Orthopedics, Affiliated Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430023; 🇨🇳 Wuhan, Hubei, China