Digital Navigation Enhances Cervical Pedicle Screw Placement Accuracy and Safety

NCT02880839 | Unknown DMC

• 1 other identifier: NantongU_001
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare the internal fixation results of three pedicle screw implantation methods and investigated the accuracy and safety of digital navigation-assisted pedicle screw placement.

Conditions

Cervical Spine Fracture

Outcome Measures

Primary Outcomes (1)

• the penetration degree of the cervical pedicle screws

  According to whether screws penetrated the pedicle and the degree of penetration, screw insertion was graded in three levels: grade I, pedicle screws do not penetrate the pedicular cortex; grade II, screw threads penetrate the cortex at the isthmic portion of the pedicle (no more than 1/4 length of the screw diameter); grade III, screws obviously penetrate the cortex at the isthmic portion of the pedicle (\> 1/4 length of the screw diameter) with risk of peripheral nerve and vessel injury, and poor stabilization of the internal fixation.

  12 months after internal fixation

Secondary Outcomes (4)

• bony fusion rate of the atlantoaxial joint

  12 and 36 months after internal fixation

• Visual analogue scale spine score

  prior to and 12 and 36 months after internal fixation

• American Spinal Injury Association Classification

  prior to and 12 and 36 months after internal fixation

• incidence of adverse events

  12 and 36 months after internal fixation

Study Arms (3)

Partial cervical lamina excision group

EXPERIMENTAL

Patients in the cervical lamina partial excision group underwent partial cervical lamina excision and cervical pedicle screw internal fixation.

Device: Partial cervical lamina excision group

Pipeline-dredge discharge group

EXPERIMENTAL

Patients in the pipeline-dredge discharge group underwent pipeline-dredge discharge and cervical pedicle screw internal fixation.

Device: Pipeline-dredge discharge group

Digital navigation group

EXPERIMENTAL

Patients in the digital navigation group underwent digital navigation-assisted cervical pedicle placement.

Device: Digital navigation group

Interventions

Partial cervical lamina excision group DEVICE

Patients with cervical fracture were assigned to undergo partial cervical lamina excision and cervical pedicle screw internal fixation.

Partial cervical lamina excision group

Pipeline-dredge discharge group DEVICE

Patients with cervical fracture were assigned to undergo pipeline-dredge discharge and cervical pedicle screw internal fixation.

Pipeline-dredge discharge group

Digital navigation group DEVICE

Patients with cervical fracture were assigned to undergo digital navigation assisted cervical pedicle screw placement.

Also known as: Digital navigation system

Digital navigation 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:

• Fracture of the posterior column of the cervical spine or fracture of the anterior-posterior column of the cervical spine without severe vertebral body injury
• Non-traumatic cervical lamina destabilization, including metastatic tumor and rheumatoid arthritis
• Kyphotic deformity after cervical lamina resection
• Segmental destabilization after nerve root or spinal cord decompression
• Subjected to revision after anterior cervical spine surgery
• Scheduled to undergo internal fixation by cervical pedicle screw
• Age approximately 62 years
• Either sex
• Provision of signed informed consent to participate in the trial

You may not qualify if:

• Cervical pedicle injury resulting from trauma or tumor
• Severe osteoporosis
• Anatomical variation of the vertebral artery
• Unable or declined to proceed with internal fixation by pedicle screws

Sponsors & Collaborators

• Nantong University: lead

Study Officials

• Junjie Guan, Master

  Affiliated Hospital of Nantong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: August 26, 2016
• Study Start: September 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: August 26, 2016

Record last verified: 2016-08