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NCT Number: NCT04980131

Application of 3-Dimensional Printing Guide Template and Pointed Lotus-style Regulator

This study aims to analysis the efficacy of the 3D printing percutaneous guide template in combination with the pointed lotus-style regulator in percutaneous pedicle screw fixation.

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Key information

Conditions

Vertebral Fracture Back Injuries Fractures, Bone Spinal Fractures Spinal Injuries Wounds and Injuries

Age range

50 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Huai'an Second People's Hospital

Huai'an, Jiangsu, 223002, China

About this study

All thoracolumbar fractures patients receiving percutaneous pedicle screw fixation (PPSF) were enrolled and randomly divided into 3 groups. Patients in Group A received traditional PPSF, while patients in Group B received PPSF with flat end lotus-style regulator and patients in Group C received PPSF with pointed lotus-style regulator.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The thoracolumbar vertebral compression fracture which the injury time is less than 7 days
  • The vertebral fracture sites where are located in T11-L2
  • No clinical neurological symptoms and signs
  • The patients who have complete preoperative X-ray, CT, MRI and other imaging data

Exclusion criteria

  • Vertebral burst fracture with spinal canal occupation
  • Fracture caused by severe osteoporosis or tumor and other pathological factors
  • Moderate and severe scoliosis
  • Patients with pedicle dysplasia
  • Patients with severe heart, liver and kidney diseases, diabetes, immune diseases, mental diseases who cannot tolerate surgery
  • Coagulation dysfunction or surgical site of the skin infection

Treatment and study plan

Pointed lotus root regulator and guide template aided PPSF

Device

20 patients in group C received PPSF with pointed lotus-style regulator

Flat ended lotus root regulator and guide template aided PPSF

Device

20 patients in group B received PPSF with flat ended lotus-style regulator

Primary outcomes

  1. First puncture success rate,number of insertions before reaching the desired position, number of fluoroscopy before reaching the desired position, radiation dosage before reaching the desired position, operation time before reaching the desired position

    Time frame: twenty months

    All the operations were successfully completed. The number of pedicles successfully first pierced in group C was higher than that in group A and group B (P<0.05);The number of insertion, fluoroscopy and operation time before the insertion needle reached the ideal position, the total number and time of intraoperative fluoroscopy, and the intraoperative blood loss in group C were all significantly lower than those of group A and group B (P<0.05)

  2. VAS scores after surgery

    Time frame: twenty-two months

    All patients were followed up 6 months after surgery. VAS scores at 1 day and 7 days after surgery were higher in Group A than those in other groups（P<0.05）, but no differences were found VAS scores at 1 , 3 and 6 months after surgery in 3 groups.Specific methods: drawing a 10cm line on the paper, one end of the horizontal line is 0, that is painless; The other end is 10, which means severe pain; The intermediate part indicates different levels of pain. Asking the patient to mark the level of pain on a horizontal line according to how he or she feels. 0-2: meaning comfortable; 3-4: slight discomfort; 5-6: moderate discomfort; 7-8: Severe discomfort;9-10: Extreme discomfort.

Sponsors and collaborators

Lead sponsor

Ming Zhang

Other

Collaborators

  • The Second People's Hospital of Huai'an

Registry information

Official study title

Application of 3-Dimensional Printing Guide Template and Pointed Lotus-style Regulator in Percutaneous Pedicle Screw Fixation for Thoracolumbar Fractures

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 28, 2021
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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