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Clinical Trial Details

Trial ID: L4311
Source ID: NCT05214235
Associated Drug: Hypoglycemic Drugs
Title: A Clinical Study on the Effect of Hypoglycemic Drugs on the Prognosis of Spinal Surgery in Diabetic Patients
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus|Spinal Diseases
Interventions: DRUG: Hypoglycemic Drugs
Outcome Measures: Primary: Preoperative Quality of Life Score, Preoperative quality of life score will be performed using a Short Form-36 Health Survey (SF-36). SF-36 is a concise health questionnaire. It is widely used to measure the quality of life in the general population, evaluate the efficacy of clinical trials, and evaluate health policy. As a concise health questionnaire, SF-36 comprehensively summarized the quality of life of the respondents from nine aspects: physiological function, physical function, physical pain, general health, energy, social function, emotional function, mental health and health transition., before surgery|Quality of Life Score at 3 Months after Surgery, Quality of life score at 3 months after surgery will be performed using a Short Form-36 Health Survey (SF-36). SF-36 is a concise health questionnaire. It is widely used to measure the quality of life in the general population, evaluate the efficacy of clinical trials, and evaluate health policy. As a concise health questionnaire, SF-36 comprehensively summarized the quality of life of the respondents from nine aspects: physiological function, physical function, physical pain, general health, energy, social function, emotional function, mental health and health transition., at 3 months after surgery|Quality of Life Score at 6 Months after Surgery, Quality of life score at 6 months after surgery will be performed using a Short Form-36 Health Survey (SF-36). SF-36 is a concise health questionnaire. It is widely used to measure the quality of life in the general population, evaluate the efficacy of clinical trials, and evaluate health policy. As a concise health questionnaire, SF-36 comprehensively summarized the quality of life of the respondents from nine aspects: physiological function, physical function, physical pain, general health, energy, social function, emotional function, mental health and health transition., at 6 months after surgery|Quality of Life Score at 1 Year after Surgery, Quality of life score at 1 year after surgery will be performed using a Short Form-36 Health Survey (SF-36). SF-36 is a concise health questionnaire. It is widely used to measure the quality of life in the general population, evaluate the efficacy of clinical trials, and evaluate health policy. As a concise health questionnaire, SF-36 comprehensively summarized the quality of life of the respondents from nine aspects: physiological function, physical function, physical pain, general health, energy, social function, emotional function, mental health and health transition., at 1 year after surgery.|Preoperative Oswestry Disability Index (ODI) or Neck Disability Index (NDI), The ODI and NDI are disease-specific questionnaires designed to gauge disability from the low back (ODI) or neck (NDI) and are scored on a 0-to-100-point scale. Values of \>40 points indicate severe disability., before surgery|Oswestry Disability Index (ODI) or Neck Disability Index (NDI) at 3 Months after Surgery, The ODI and NDI are disease-specific questionnaires designed to gauge disability from the low back (ODI) or neck (NDI) and are scored on a 0-to-100-point scale. Values of \>40 points indicate severe disability., at 3 months after surgery|Oswestry Disability Index (ODI) or Neck Disability Index (NDI) at 6 Months after Surgery, The ODI and NDI are disease-specific questionnaires designed to gauge disability from the low back (ODI) or neck (NDI) and are scored on a 0-to-100-point scale. Values of \>40 points indicate severe disability., at 6 months after surgery|Oswestry Disability Index (ODI) or Neck Disability Index (NDI) at 1 Year after Surgery, The ODI and NDI are disease-specific questionnaires designed to gauge disability from the low back (ODI) or neck (NDI) and are scored on a 0-to-100-point scale. Values of \>40 points indicate severe disability., at 1 year after surgery|Preoperative Visual Analogue Scale (VAS), The VAS is used to assess pain. The basic method is to use a swimming scale about 10cm long, with one side marked with 10 scales, both ends of which are "0" and "10" respectively. 0 indicates no pain, and 10 indicates the most severe pain that is unbearable., before surgery|Visual Analogue Scale (VAS) at 3 Months after Surgery, The VAS is used to assess pain. The basic method is to use a swimming scale about 10cm long, with one side marked with 10 scales, both ends of which are "0" and "10" respectively. 0 indicates no pain, and 10 indicates the most severe pain that is unbearable., at 3 months after surgery|Visual Analogue Scale (VAS) at 6 Months after Surgery, The VAS is used to assess pain. The basic method is to use a swimming scale about 10cm long, with one side marked with 10 scales, both ends of which are "0" and "10" respectively. 0 indicates no pain, and 10 indicates the most severe pain that is unbearable., at 6 months after surgery|Visual Analogue Scale (VAS) at 1 Year after Surgery, The VAS is used to assess pain. The basic method is to use a swimming scale about 10cm long, with one side marked with 10 scales, both ends of which are "0" and "10" respectively. 0 indicates no pain, and 10 indicates the most severe pain that is unbearable., at 1 year after surgery | Secondary: Number of Participants with Spinal Fixation Loosening at 3 Months after Surgery, Spinal fixation loosening is evaluated by anteroposterior and lateral X-ray. The evaluation criteria were: a gap of more than 1mm around the screw is considered as spinal fixation loosening., at 3 months after surgery|Number of Participants with Spinal Fixation Loosening at 6 Months after Surgery, Spinal fixation loosening is evaluated by anteroposterior and lateral X-ray. The evaluation criteria were: a gap of more than 1mm around the screw is considered as spinal fixation loosening., at 6 months after surgery|Number of Participants with Spinal Fixation Loosening at 1 year after Surgery, Spinal fixation loosening is evaluated by CT scan. The evaluation criteria were: a gap of more than 1mm around the screw is considered as spinal fixation loosening., at 1 year after surgery|Number of Participants with Spinal Fusion at 3 Months after Surgery, Dynamic X-ray is used to evaluate the spinal fusion. The criteria of spinal fusion:(1) there is continuous bone trabeculae passing between vertebrae with increased density; (2) The translation on the X-ray dynamic position film is less than 3mm, and the angular motion is less than 5°; (3) The bone connected to the vertebral body is constantly growing; (4) The relative displacement between adjacent spinous processes of fusion segment measured by X-ray dynamic position film is less than or equal to 2 mm., at 3 months after surgery|Number of Participants with Spinal Fusion at 6 Months after Surgery, Dynamic X-ray is used to evaluate the spinal fusion. The criteria of spinal fusion:(1) there is continuous bone trabeculae passing between vertebrae with increased density; (2) The translation on the X-ray dynamic position film is less than 3mm, and the angular motion is less than 5°; (3) The bone connected to the vertebral body is constantly growing; (4) The relative displacement between adjacent spinous processes of fusion segment measured by X-ray dynamic position film is less than or equal to 2 mm., at 6 months after surgery|Number of Participants with Spinal Fusion at 1 Year after Surgery, Dynamic X-ray is used to evaluate the spinal fusion. The criteria of spinal fusion:(1) there is continuous bone trabeculae passing between vertebrae with increased density; (2) The translation on the X-ray dynamic position film is less than 3mm, and the angular motion is less than 5°; (3) The bone connected to the vertebral body is constantly growing; (4) The relative displacement between adjacent spinous processes of fusion segment measured by X-ray dynamic position film is less than or equal to 2 mm., at 1 year after surgery
Sponsor/Collaborators: Sponsor: Xijing Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 124
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2022-02-07
Completion Date: 2024-02-29
Results First Posted:
Last Update Posted: 2022-06-16
Locations: The First Affiliated Hospital of Air Force Medical University (Xijing Hospital), Xi'an, Shaanxi, 710032, China
URL: https://clinicaltrials.gov/show/NCT05214235