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Clinical Trials/NCT04133103
NCT04133103
Unknown
Not Applicable

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

Beijing Jishuitan Hospital1 site in 1 country150 target enrollmentOctober 16, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Degenerative Disease
Sponsor
Beijing Jishuitan Hospital
Enrollment
150
Locations
1
Primary Endpoint
Visual Analogue Scale
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 16, 2019
End Date
March 2, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wei Tian

director of spine department

Beijing Jishuitan Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Visual Analogue Scale

Time Frame: 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 Outcomes

  • Oswestry Disability Index(3 months postoperatively)
  • Japanese Orthopedic Association(3 months postoperatively)

Study Sites (1)

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