Early Mobilisation in the Surgical Robot Assisted Spinal Surgery

Not Applicable

• Conditions: Fracture; Degenerative Disease
• Interventions: Procedure: first ambulation at 4 hour after operation

• Registration Number: NCT04133103
• Lead Sponsor: Beijing Jishuitan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-13
• Study Start: 2019-10-16
• Study First Submitted QC: 2019-10-17
• Study First Posted: 2019-10-21
• Last Update Submitted: 2019-12-09
• Last Update Posted: 2019-12-11
• Primary Completion: 2020-01-31
• Study Completion: 2020-03-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
First ambulation at 4 hours after operation	first ambulation at 4 hour after operation	-

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale	3 months postoepratively	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.

Secondary Outcome Measures

Name	Time	Method
Oswestry Disability Index	3 months postoperatively	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.
Japanese Orthopedic Association	3 months postoperatively	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.

Trial Locations

Locations (1)

Wei Tian; 🇨🇳 Beijing, China