Early Mobilisation in the Surgical Robot Assisted Spinal Surgery

Study Overview
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Brief Summary
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In this study, patients who underwent lumbar spine surgery in our hospital were included. A prospective study was conducted to investigate the effects of early mobilisation on postoperative complications, functual outcomes and patient satisfaction after robotic assisted lumbar spinal surgery.

Official Title
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A Prospective Study of Early Mobilisation in the Surgical Robot Assisted Spinal Surgery

Conditions
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Degenerative Disease, Fracture

Intervention / Treatment
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* Procedure: first ambulation at 4 hour after operation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of degenerative diseases or spinal fracture single level instrumentation sugery sign informed consent Exclusion Criteria: multilevel instrumentaion surgery diagnosis of severe osteoperosis (BMD < 60mg/cm3) by QCT coagulant function abnormality severe internal disease not suitable for inclusion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: First ambulation at 24 hours after operation<br> | |
| Experimental: First ambulation at 4 hours after operation<br> | Procedure: first ambulation at 4 hour after operation<br>* Two groups were conducted for first ambulation at 4 or 24 hours aftër operation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale | Low back pain and leg pain is an important sign and a frequent patient complaint. The VAS pain scoring standard (scores from 0 to 10) was as following: 0 means painless; 1-3 means mild pain that the patient could endure; 4-6 means patient was in pain that could be endured and be able to sleep; and 7-10 means patient had intense pain and was unable to tolerate the pain. | preoperative | 
| Visual Analogue Scale | Low back pain and leg pain is an important sign and a frequent patient complaint. The VAS pain scoring standard (scores from 0 to 10) was as following: 0 means painless; 1-3 means mild pain that the patient could endure; 4-6 means patient was in pain that could be endured and be able to sleep; and 7-10 means patient had intense pain and was unable to tolerate the pain. | 4 hours postoperatively | 
| Visual Analogue Scale | Low back pain and leg pain is an important sign and a frequent patient complaint. The VAS pain scoring standard (scores from 0 to 10) was as following: 0 means painless; 1-3 means mild pain that the patient could endure; 4-6 means patient was in pain that could be endured and be able to sleep; and 7-10 means patient had intense pain and was unable to tolerate the pain. | 24 hours postoperatively | 
| Visual Analogue Scale | Low back pain and leg pain is an important sign and a frequent patient complaint. The VAS pain scoring standard (scores from 0 to 10) was as following: 0 means painless; 1-3 means mild pain that the patient could endure; 4-6 means patient was in pain that could be endured and be able to sleep; and 7-10 means patient had intense pain and was unable to tolerate the pain. | 3 months postoepratively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Japanese Orthopedic Association | The Japanese Orthopedic Association score was used to evaluate the neurological function of patients with lumbar degeneration and treatment effectiveness. The highest possible total score from categories for a normal person is 29 points. Therefore, treatment improvement rate = [(post-treatment score - pre-treatment score) / (29 - pre-treatment score)] × 100%, and ≥75% means excellent; 50%-74% means good; 25%-49% means fair; 0-24% means poor. | preoperative | 
| Japanese Orthopedic Association | The Japanese Orthopedic Association score was used to evaluate the neurological function of patients with lumbar degeneration and treatment effectiveness. The highest possible total score from categories for a normal person is 29 points. Therefore, treatment improvement rate = [(post-treatment score - pre-treatment score) / (29 - pre-treatment score)] × 100%, and ≥75% means excellent; 50%-74% means good; 25%-49% means fair; 0-24% means poor. | 3 months postoperatively | 
| Oswestry Disability Index | The Oswestry Disability Index is one of the principal condition-speciﬁc outcome measures used in the management of spinal disorders. Rounding the percentage to a whole number is suggested for convenience. So the final score may be summarized as: [total score / (5 × number of questions answered)] × 100%. It is suggested rounding the percentage to a whole number for convenience. We defined that 0-20% means mild; 21%-40% means moderate; 41%-60% means severe; 61%-80% means very severe；80%-100% means patients very exaggerated symptoms. | preoperative | 
| Oswestry Disability Index | The Oswestry Disability Index is one of the principal condition-speciﬁc outcome measures used in the management of spinal disorders. Rounding the percentage to a whole number is suggested for convenience. So the final score may be summarized as: [total score / (5 × number of questions answered)] × 100%. It is suggested rounding the percentage to a whole number for convenience. We defined that 0-20% means mild; 21%-40% means moderate; 41%-60% means severe; 61%-80% means very severe；80%-100% means patients very exaggerated symptoms. | 3 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early mobilisation, robot, spine, enhanced recovery