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

NCT ID: NCT06591442

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-03
• Study Completion Date: 2027-09-03

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

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Elderly group patients (60-74 years).

This is an observational study

Intervention Type: DIAGNOSTIC_TEST

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.

Advanced age group patients (≥75 years)

This is an observational study

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

This 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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Caoyang

Head of orthopedics; Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Wuhan, Hubei, China

Countries

China

Other Identifiers

2024(0735)

Identifier Type: OTHER

Identifier Source: secondary_id

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

Identifier Type: -

Identifier Source: org_study_id