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

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

Enrolling by Invitation

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Key information

Conditions

Lumbar Disk Herniation Bone Diseases Cervical Radiculopathy Cervical Spondylotic Myelopathy Hernia Intervertebral Disc Displacement Lumbar Spinal Stenosis Lumbar Spondylolisthesis Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Radiculopathy Spinal Diseases Spinal Stenosis Spondylolisthesis Spondylolysis Spondylosis

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Wuhan, Hubei, 430023, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

Safety Metrics for Enhanced Recovery After Spinal Fusion Surgery

Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2027
First posted: Sep 19, 2024
Registry last updated: Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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