Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Early Mobilisation in the Surgical Robot Assisted Spinal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04133103
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Wei Tian, 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.

Condition or disease Intervention/treatment Phase
Degenerative Disease Fracture Procedure: first ambulation at 4 hour after operation Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Study of Early Mobilisation in the Surgical Robot Assisted Spinal Surgery
Estimated Study Start Date : October 16, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : March 2, 2020

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




Primary Outcome Measures :
  1. Visual Analogue Scale [ Time Frame: preoperative ]
    Low back pain and leg pain is an important sign and a frequent patient complaint. We used the VAS score to assess the degree of patients' pain. A 10-point visual analog scale (VAS) was used for pain measure.

  2. Visual Analogue Scale [ Time Frame: 4 hours postoperatively ]
    Low back pain and leg pain is an important sign and a frequent patient complaint. We used the VAS score to assess the degree of patients' pain. A 10-point visual analog scale (VAS) was used for pain measure.

  3. Visual Analogue Scale [ Time Frame: 24 hours postoperatively ]
    Low back pain and leg pain is an important sign and a frequent patient complaint. We used the VAS score to assess the degree of patients' pain. A 10-point visual analog scale (VAS) was used for pain measure.

  4. Visual Analogue Scale [ Time Frame: 3 months postoepratively ]
    Low back pain and leg pain is an important sign and a frequent patient complaint. We used the VAS score to assess the degree of patients' pain. A 10-point visual analog scale (VAS) was used for pain measure.


Secondary Outcome Measures :
  1. Japanese Orthopedic Association [ Time Frame: preoperative ]
    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

  2. Japanese Orthopedic Association [ Time Frame: 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

  3. Oswestry Disability Index [ Time Frame: preoperative ]
    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.

  4. Oswestry Disability Index [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133103


Contacts
Layout table for location contacts
Contact: Wei Tian, MD tianwei2019@yeah.net
Contact: Wei Tian 01058516959 tianwei2019@yeah.net

Locations
Layout table for location information
China
Wei Tian Recruiting
Beijing, China, 100035
Contact: Wei Tian       tianwei2019@yeah.net   
Sponsors and Collaborators
Beijing Jishuitan Hospital
Investigators
Layout table for investigator information
Study Director: Wei Tian Beijng Jishuitan Hospital

Layout table for additonal information
Responsible Party: Wei Tian, director of spine department, Beijing Jishuitan Hospital
ClinicalTrials.gov Identifier: NCT04133103     History of Changes
Other Study ID Numbers: Jilunke201909-24
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wei Tian, Beijing Jishuitan Hospital:
early mobilisation
robot
spine
enhanced recovery