Evaluation of the Safety and Efficacy of Smart Orthopedic Minimally Invasive Surgical Systems for Spinal Surgery

NCT ID: NCT04956588

Last Updated: 2021-07-09

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-12-31

Brief Summary

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To evaluate the safety and effectiveness of the intelligent orthopedic minimally invasive surgery system developed by Shenzhen Xinjunte Intelligent Medical Equipment Co., Ltd. in spinal surgery.

Detailed Description

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Conditions

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Spine Disease Spinal Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The outcomes assessor was blinded when evaluating the subject's imaging data (i.e., when calculating the deviation of the nail placement).

Study Groups

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experimental group

Group Type EXPERIMENTAL

surgical robot

Intervention Type COMBINATION_PRODUCT

The surgical robot completed the screw placement according to the surgical plan, and the researchers closely monitored the screw placement process.

control group

Group Type ACTIVE_COMPARATOR

controlled approach

Intervention Type COMBINATION_PRODUCT

The screw placement was performed using a controlled approach according to the surgical plan.

Interventions

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surgical robot

The surgical robot completed the screw placement according to the surgical plan, and the researchers closely monitored the screw placement process.

Intervention Type COMBINATION_PRODUCT

controlled approach

The screw placement was performed using a controlled approach according to the surgical plan.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

\- Age 18-65, gender unlimited; In line with the surgical conditions for spinal surgery requiring Kirschner wire implantation, and the treatment plan allows open or minimally invasive surgery; Signed the informed consent and agreed to participate in the study; Complete the filter check and meet all the entry criteria in the filter table.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Shenzhen Second People's Hospital

OTHER

Sponsor Role collaborator

Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking University Third Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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D2017079

Identifier Type: -

Identifier Source: org_study_id

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