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

NCT06591442 | Enrolling By Invitation

• 2 other identifiers: UHCT-IEC-SOP-016-03-01-2024-12024(0735)
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• Safety Metrics for Enhanced Recovery After Spinal Fusion 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.

  Baseline. 7 days, 3 months, 6 months, 9 months and 12 months after surgery

Study Arms (2)

Elderly group patients (60-74 years).

Diagnostic Test: This is an observational study

Advanced age group patients (≥75 years)

Diagnostic Test: This is an observational study

Interventions

This is an observational study 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); Elderly group patients (60-74 years).

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Department of Orthopedics, Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, China

You may qualify if:

• Informed consent signed and dated by subject or guardian
• Commit to follow the research procedures and cooperate with the whole process of the study
• The subjects are 60 years old or older, regardless of gender
• Patients with degenerative spinal diseases requiring spinal fusion surgery
• Generally in good physical condition
• Able to adhere to and cooperate with research interventions, such as oral medication
• 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

You may not qualify if:

• Acute infection
• Congenital malformation
• Abnormal anatomy or skeletal variation
• Malignant tumor
• The surgical area was locally infected with symptoms of local inflammation
• Fever or leukocytosis
• Morbid obesity
• Pregnant and nursing women
• Mental illness
• 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
• Patients who are unwilling to cooperate with post-operative treatment
• Any time an implant is performed it interferes with the anatomy or intended physiological function of the patient

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhan, Hubei, 430023, China

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement; Spinal Stenosis; Spondylolisthesis; Radiculopathy

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Spondylolysis; Spondylosis; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of orthopedics; Professor

Study Record Dates

• First Submitted: September 7, 2024
• First Posted: September 19, 2024
• Study Start: September 3, 2024
• Primary Completion (Estimated): September 3, 2027
• Study Completion (Estimated): September 3, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)