NCT04133103

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

October 16, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2020

Completed
Last Updated

December 11, 2019

Status Verified

October 1, 2019

Enrollment Period

4 months

First QC Date

October 13, 2019

Last Update Submit

December 9, 2019

Conditions

Degenerative DiseaseFracture

Keywords

early mobilisationrobotspineenhanced recovery

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Japanese Orthopedic Association

    preoperative

  • Japanese Orthopedic Association

    3 months postoperatively

  • Oswestry Disability Index

    preoperative

  • Oswestry Disability Index

    3 months postoperatively

Study Arms (2)

First ambulation at 24 hours after operation

NO INTERVENTION

First ambulation at 4 hours after operation

EXPERIMENTAL
Procedure: first ambulation at 4 hour after operation

Interventions

first ambulation at 4 hour after operationPROCEDURE

Two groups were conducted for first ambulation at 4 or 24 hours aftër operation

First ambulation at 4 hours after operation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of degenerative diseases or spinal fracture
  • single level instrumentation sugery
  • sign informed consent

You may not qualify if:

  • multilevel instrumentaion surgery
  • diagnosis of severe osteoperosis (BMD \< 60mg/cm3) by QCT
  • coagulant function abnormality
  • severe internal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wei Tian

Beijing, 100035, China

RECRUITING

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Wei Tian

    Beijng Jishuitan Hospital

    STUDY DIRECTOR

Central Study Contacts

Wei Tian, MD

CONTACT

tianwei2019@yeah.net

Wei Tian

CONTACT

010-58516959tianwei2019@yeah.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director of spine department

Study Record Dates

First Submitted

October 13, 2019

First Posted

October 21, 2019

Study Start

October 16, 2019

Primary Completion

January 31, 2020

Study Completion

March 2, 2020

Last Updated

December 11, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)