Screening and Prospective Cohort Study of Risk Factors for Enhanced Recovery After Spinal Fusion … (NCT06591442) | Clinical Trial Compass
By InvitationNot Applicable
Screening and Prospective Cohort Study of Risk Factors for Enhanced Recovery After Spinal Fusion Surgery in Advanced Age Patient
China500 participantsStarted 2024-09-03
Plain-language summary
To determine the high risk factors affecting accelerated recovery after spinal fusion surgery in advanced age patient.
Who can participate
Age range60 Years
SexALL
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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
What they're measuring
1
Safety Metrics for Enhanced Recovery After Spinal Fusion Surgery
Timeframe: Baseline. 7 days, 3 months, 6 months, 9 months and 12 months after surgery
Trial details
NCT IDNCT06591442
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology