Early Mobilisation in the Surgical Robot Assisted Spinal Surgery

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

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.

Study Overview

• Status: Unknown
• Conditions: Fracture; Degenerative Disease
• Intervention / Treatment: Procedure: first ambulation at 4 hour after operation

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei Tian, MD; Email: tianwei2019@yeah.net
• Study Contact Backup: Name: Wei Tian; Phone Number: 010-58516959; Email: tianwei2019@yeah.net

Study Locations

• China
  • Beijing, China, 100035
    • Recruiting
    • Wei Tian
    • Contact: Wei Tian; Email: tianwei2019@yeah.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: First ambulation at 24 hours after operation
Experimental: First ambulation at 4 hours after operation	Procedure: first ambulation at 4 hour after operation; Two groups were conducted for first ambulation at 4 or 24 hours aftër operation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beijing Jishuitan Hospital
• Investigators: Study Director: Wei Tian, Beijng Jishuitan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2019
• Primary Completion (Anticipated): January 31, 2020
• Study Completion (Anticipated): March 2, 2020

Study Registration Dates

• First Submitted: October 13, 2019
• First Submitted That Met QC Criteria: October 17, 2019
• First Posted (Actual): October 21, 2019

Study Record Updates

• Last Update Posted (Actual): December 11, 2019
• Last Update Submitted That Met QC Criteria: December 9, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: spine; robot; enhanced recovery; early mobilisation
• Other Study ID Numbers: Jilunke201909-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No