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

NCT04956588 | Completed Phase 3 DMC

• 1 other identifier: D2017079
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spine Disease; Spinal Fractures

Keywords

smart orthopedics; minimally invasive surgical systems; spinal surgery

Outcome Measures

Primary Outcomes (3)

• Incorrect placement of guide pin

  After the subject completes the preparation for guide needle placement (e.g. reduction), a C-arm scan is performed. Get the image. Surgical planning is performed on images. Control robot positioning. The doctor completes the insertion of the guide needle. Then the C-arm scan image was obtained again. Fusion of two groups of images on a third-party software. The deviation distance between the entry and exit points of the guide needle and the surgical plan was measured. The accuracy of guide needle placement was evaluated by the deviation of guide needle placement.

  During operation

• Number of X-ray exposures

  The number of exposures was defined as the number of times the investigator used the X-ray during the operative period and also included the number of exposures performed to determine the surgical site.

  During operation

• X-ray exposure time

  X-ray exposure time refers to the total time of using X-rays from the planning of the operation to the end of the operation.

  During operation

Study Arms (2)

experimental group

EXPERIMENTAL

Combination Product: surgical robot

control group

ACTIVE COMPARATOR

Combination Product: controlled approach

Interventions

surgical robot COMBINATION_PRODUCT

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

experimental group

controlled approach COMBINATION_PRODUCT

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

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• Shenzhen Second People's Hospital: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, China

Location

MeSH Terms

Conditions

Spinal Diseases; Spinal Fractures

Interventions

Robotic Surgical Procedures

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Surgery, Computer-Assisted; Surgical Procedures, Operative; Robotics; Automation; Technology; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor was blinded when evaluating the subject's imaging data (i.e., when calculating the deviation of the nail placement).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 9, 2021
• Study Start: September 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: July 9, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)