Early Mobilisation in the Surgical Robot Assisted Spinal Surgery

Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04133103
• Other study ID #: Jilunke201909-24
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2019
• Est. completion date: March 2, 2020

Study information

• Verified date: October 2019
• Source: Beijing Jishuitan Hospital
• Contact: Wei Tian, MD
• Email: tianwei2019[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 2, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disease
• Fracture

Intervention

Procedure:
• first ambulation at 4 hour after operation
Two groups were conducted for first ambulation at 4 or 24 hours aftër operation

Locations

Country	Name	City	State
China	Wei Tian	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Jishuitan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Oswestry Disability Index	The Oswestry Disability Index is one of the principal condition-speci?c 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
Secondary	Oswestry Disability Index	The Oswestry Disability Index is one of the principal condition-speci?c 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