Bone Screws Clinical Trial
Official title:
A Comparison of Pedicle Screws Placement Accuracy in Thoracolumbar Spine Using Two Guidance Techniques: O-arm Navigation and Cervical Distractor Screws
| NCT number | NCT04196153 |
| Other study ID # | kashabmo |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | October 10, 2019 |
| Est. completion date | October 2021 |
Pedicle screw instrumentation is used nowadays mostly in spine fusion which is a surgical option for treating variety of conditions such as vertebral fractures, degenerative spine diseases, spine tumors and spine deformities. However, pedicle screws misplacement and breach may occur and be a great cause of morbidity. The breach rate can be as high as 20-39.8% but most of the time only small number is associated with complications. Surgeons use assistive technique to avoid screw breached and improve screw placement accuracy. Investigators aim in this study to compare accuracy of pedicle screws placement using two guidance techniques are O-arm navigation the latest assistive imaging technique that uses three-dimensional (3-D) real time images to allow the surgeons follow the screw's trajectory, and standard cervical distractor screws to mark the entry point and trajectory.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | October 2021 |
| Est. primary completion date | September 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients who need a thoracolumbar spine surgery that require pedicle screw insertion. Exclusion Criteria: - Patients whose surgeries in cervical spine - Patients whose surgeries are for correction of deformities such as scoliosis and kyphosis, patients with infections or tumors. |
| Country | Name | City | State |
|---|---|---|---|
| Saudi Arabia | King Abdulaziz Medical City | Jeddah | Eastern Province |
| Lead Sponsor | Collaborator |
|---|---|
| King Abdullah International Medical Research Center |
Saudi Arabia,
BOUCHER HH. A method of spinal fusion. J Bone Joint Surg Br. 1959 May;41-B(2):248-59. — View Citation
Broom MJ, Banta JV, Renshaw TS. Spinal fusion augmented by luque-rod segmental instrumentation for neuromuscular scoliosis. J Bone Joint Surg Am. 1989 Jan;71(1):32-44. — View Citation
Gaines RW Jr. The use of pedicle-screw internal fixation for the operative treatment of spinal disorders. J Bone Joint Surg Am. 2000 Oct;82(10):1458-76. Review. — View Citation
Gertzbein SD, Robbins SE. Accuracy of pedicular screw placement in vivo. Spine (Phila Pa 1976). 1990 Jan;15(1):11-4. — View Citation
Kim TT, Drazin D, Shweikeh F, Pashman R, Johnson JP. Clinical and radiographic outcomes of minimally invasive percutaneous pedicle screw placement with intraoperative CT (O-arm) image guidance navigation. Neurosurg Focus. 2014 Mar;36(3):E1. doi: 10.3171/2014.1.FOCUS13531. — View Citation
Krag MH, Beynnon BD, Pope MH, DeCoster TA. Depth of insertion of transpedicular vertebral screws into human vertebrae: effect upon screw-vertebra interface strength. J Spinal Disord. 1988;1(4):287-94. — View Citation
Liljenqvist UR, Halm HF, Link TM. Pedicle screw instrumentation of the thoracic spine in idiopathic scoliosis. Spine (Phila Pa 1976). 1997 Oct 1;22(19):2239-45. — View Citation
Luo TD, Polly DW Jr, Ledonio CG, Wetjen NM, Larson AN. Accuracy of Pedicle Screw Placement in Children 10 Years or Younger Using Navigation and Intraoperative CT. Clin Spine Surg. 2016 Apr;29(3):E135-8. doi: 10.1097/BSD.0000000000000230. — View Citation
Puvanesarajah V, Liauw JA, Lo SF, Lina IA, Witham TF. Techniques and accuracy of thoracolumbar pedicle screw placement. World J Orthop. 2014 Apr 18;5(2):112-23. doi: 10.5312/wjo.v5.i2.112. eCollection 2014 Apr 18. Review. — View Citation
Roy-Camille R, Saillant G, Mazel C. Internal fixation of the lumbar spine with pedicle screw plating. Clin Orthop Relat Res. 1986 Feb;(203):7-17. — View Citation
Scarone P, Vincenzo G, Distefano D, Del Grande F, Cianfoni A, Presilla S, Reinert M. Use of the Airo mobile intraoperative CT system versus the O-arm for transpedicular screw fixation in the thoracic and lumbar spine: a retrospective cohort study of 263 patients. J Neurosurg Spine. 2018 Oct;29(4):397-406. doi: 10.3171/2018.1.SPINE17927. Epub 2018 Jul 6. — View Citation
Tajsic T, Patel K, Farmer R, Mannion RJ, Trivedi RA. Spinal navigation for minimally invasive thoracic and lumbosacral spine fixation: implications for radiation exposure, operative time, and accuracy of pedicle screw placement. Eur Spine J. 2018 Aug;27(8):1918-1924. doi: 10.1007/s00586-018-5587-z. Epub 2018 Apr 17. — View Citation
Vaccaro AR, Rizzolo SJ, Balderston RA, Allardyce TJ, Garfin SR, Dolinskas C, An HS. Placement of pedicle screws in the thoracic spine. Part II: An anatomical and radiographic assessment. J Bone Joint Surg Am. 1995 Aug;77(8):1200-6. — View Citation
Verma R, Krishan S, Haendlmayer K, Mohsen A. Functional outcome of computer-assisted spinal pedicle screw placement: a systematic review and meta-analysis of 23 studies including 5,992 pedicle screws. Eur Spine J. 2010 Mar;19(3):370-5. doi: 10.1007/s00586-009-1258-4. Epub 2010 Jan 6. Review. — View Citation
* Note: There are 14 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate screws breach | Investigators will determine the rate of screws breach in the two comparison groups | 6 months | |
| Primary | Screw insertion time | screw insertion time in each technique which will be assessed by calculating the total time from puncture at the entry point by awl to complete all screw insertions into pedicles divided by the number of pedicle screws | 5 hours | |
| Primary | screws revision times | investigators will determine which group needs more screws revision | 6 months | |
| Primary | degree of screws breach | Investigators will determine degree of screws breach in the two comparison groups | 6 months | |
| Secondary | Direction of the breach | investigators will ascertain direction of the breach, if it is lateral ,medial , inferior , or superior. | 6 months | |
| Secondary | complications | the two groups will be compared in rate of neurological or vascular complications. | Up to 24 weeks |