Early Mobilisation in the Surgical Robot Assisted Spinal Surgery

NCT ID: NCT04133103

Last Updated: 2019-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-16

Study Completion Date

2020-03-02

Brief Summary

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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.

Detailed Description

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Conditions

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Degenerative Disease Fracture

Keywords

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early mobilisation robot spine enhanced recovery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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First ambulation at 24 hours after operation

Group Type NO_INTERVENTION

No interventions assigned to this group

First ambulation at 4 hours after operation

Group Type EXPERIMENTAL

first ambulation at 4 hour after operation

Intervention Type PROCEDURE

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

Interventions

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first ambulation at 4 hour after operation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Jishuitan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wei Tian

director of spine department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei Tian

Role: STUDY_DIRECTOR

Beijng Jishuitan Hospital

Locations

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Wei Tian

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei Tian, MD

Role: CONTACT

Email: [email protected]

Wei Tian

Role: CONTACT

Phone: 010-58516959

Email: [email protected]

Facility Contacts

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Wei Tian

Role: primary

Other Identifiers

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Jilunke201909-24

Identifier Type: -

Identifier Source: org_study_id