Cortical Bone Trajectory Screws vs. Traditional Pedicle Screws Fixation

Lumbar Disc Herniation Clinical Trial

Official title:

Transforaminal Lumbar Interbody Fusion With Cortical Bone Trajectory Screws vs. Traditional Pedicle Screws Fixation: a Multicentre Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03105167
• Other study ID #: SAHoWMU-CR2017-08-106
• Status: Recruiting
• Phase: N/A
• Start date: May 7, 2018
• Est. completion date: December 13, 2021

Study information

• Verified date: July 2018
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Transforaminal lumbar interbody fusion (TLIF) had been favorable for effectively decrease pain and disability in specific spinal disorders; however, there has been concern regarding pedicle screw placement during TLIF surgery. Recently, several biomechanical studies had demonstrated that CBT technique achieves screw purchase and strength equivalent to or greater than the traditional method. Furthermore, Only 1 report examined the surgical outcomes of TLIF with CBT screws fixation compared with TLIF using traditional pedicle screws fixation. TLIF with CBT screws fixation may be effective for specific spinal disorders, but the evidence supporting this possibility is still limited.

Description:

Methods and analysis: Blinded Randomized Controlled Trial (RCT) will be conducted. A total of 108 participants will be randomly allocated to either a CBT-TLIF group or a PS-TLIF group at a ratio of 1:1. The primary clinical outcome measures are: change in back and lower limb pain with Visual analogue scale (VAS) and change in quality adjusted life years (QALY) will be assessed by EQ-5D-5L. Measurements will be carried out at five fixed time points (pre-operatively and at 3, 6, 12 and 24 months).

Ethics and dissemination: The study had been reviewed and approved by the ethics committee of the Second affiliated hospital of the Wenzhou Medical University, Wenzhou, China(batch:2017-03). The results will be presented in peer-reviewed journals and related website within 2 years after the last operation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: December 13, 2021
• Est. primary completion date: December 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age of at least 18 years;

2. All of participants will be informed consent;

3. Chronic low back pain (visual analogue scale at least 3 out of 10 at rest and at least 5 out of 10 under physical strain) after having failed conservative treatment for 6 months;

4. Single-segment lower lumbar vertebral disease (Including lumbar spinal cannal stenosis, foraminal stenosis, segmental instability, lumbar disc herniation, and painful disc degeneration (back disc);

Exclusion Criteria:

1. Serious deformity of lumbar vertebrae;

2. Dysplasia of lumbar pedicle or vertebral laminar;

3. Obvious osteoporosis of lumbar vertebrae;

4. Metabolic bone diseases such as osteomalacia or Paget's disease;

5. Spondylolisthesis > grade 2 (Meyerding);

6. Caudaequina injury or severe radiculopathy;

7. Post inflammatory instability of the vertebral spine;

8. Body mass index > 30;

9. Immunologic diseases or Metabolic syndrome;

10. Therapy with systemic corticosteroids or immunosuppressants;

11. Current using Coumadin (or Warfarin) or Heparin therapy for more than 6 months at the time of operation.

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Lumbar Disc Herniation
• Spinal Stenosis
• Spinal Stenosis Lumbar

Intervention

Procedure:
• cortical bone trajectory screws
cortical bone trajectory screws fixation takes the place of traditional pedicle screws fixation will be used in transforaminal lumbar interbody fusion.
• pedicle screws
traditional pedicle screws fixation will be used in transforaminal lumbar interbody fusion.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (19)

Baluch DA, Patel AA, Lullo B, Havey RM, Voronov LI, Nguyen NL, Carandang G, Ghanayem AJ, Patwardhan AG. Effect of physiological loads on cortical and traditional pedicle screw fixation. Spine (Phila Pa 1976). 2014 Oct 15;39(22):E1297-302. doi: 10.1097/BRS — View Citation

Brayda-Bruno M, Tibiletti M, Ito K, Fairbank J, Galbusera F, Zerbi A, Roberts S, Wachtel E, Merkher Y, Sivan SS. Advances in the diagnosis of degenerated lumbar discs and their possible clinical application. Eur Spine J. 2014 Jun;23 Suppl 3:S315-23. doi: — View Citation

Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8 — View Citation

Dixon JS, Bird HA. Reproducibility along a 10 cm vertical visual analogue scale. Ann Rheum Dis. 1981 Feb;40(1):87-9. — View Citation

Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. Review. — View Citation

Hägg O, Fritzell P, Nordwall A; Swedish Lumbar Spine Study Group. The clinical importance of changes in outcome scores after treatment for chronic low back pain. Eur Spine J. 2003 Feb;12(1):12-20. Epub 2002 Oct 24. — View Citation

Harms JG, Jeszenszky D. [Not Available]. Oper Orthop Traumatol. 1998 Jun;10(2):90-102. German. — View Citation

Kasukawa Y, Miyakoshi N, Hongo M, Ishikawa Y, Kudo D, Shimada Y. Short-Term Results of Transforaminal Lumbar Interbody Fusion Using Pedicle Screw with Cortical Bone Trajectory Compared with Conventional Trajectory. Asian Spine J. 2015 Jun;9(3):440-8. doi: — View Citation

M Versteegh M, M Vermeulen K, M A A Evers S, de Wit GA, Prenger R, A Stolk E. Dutch Tariff for the Five-Level Version of EQ-5D. Value Health. 2016 Jun;19(4):343-52. doi: 10.1016/j.jval.2016.01.003. Epub 2016 Mar 30. — View Citation

Matsukawa K, Kato T, Yato Y, Sasao H, Imabayashi H, Hosogane N, Asazuma T, Chiba K. Incidence and Risk Factors of Adjacent Cranial Facet Joint Violation Following Pedicle Screw Insertion Using Cortical Bone Trajectory Technique. Spine (Phila Pa 1976). 201 — View Citation

Matsukawa K, Yato Y, Kato T, Imabayashi H, Asazuma T, Nemoto K. In vivo analysis of insertional torque during pedicle screwing using cortical bone trajectory technique. Spine (Phila Pa 1976). 2014 Feb 15;39(4):E240-5. doi: 10.1097/BRS.0000000000000116. — View Citation

Matsukawa K, Yato Y, Nemoto O, Imabayashi H, Asazuma T, Nemoto K. Morphometric measurement of cortical bone trajectory for lumbar pedicle screw insertion using computed tomography. J Spinal Disord Tech. 2013 Aug;26(6):E248-53. doi: 10.1097/BSD.0b013e31828 — View Citation

Okuda S, Miyauchi A, Oda T, Haku T, Yamamoto T, Iwasaki M. Surgical complications of posterior lumbar interbody fusion with total facetectomy in 251 patients. J Neurosurg Spine. 2006 Apr;4(4):304-9. — View Citation

Omidi-Kashani F, Hasankhani EG, Ashjazadeh A. Lumbar spinal stenosis: who should be fused? An updated review. Asian Spine J. 2014 Aug;8(4):521-30. doi: 10.4184/asj.2014.8.4.521. Epub 2014 Aug 19. Review. — View Citation

Ostelo RW, de Vet HC. Clinically important outcomes in low back pain. Best Pract Res Clin Rheumatol. 2005 Aug;19(4):593-607. Review. — View Citation

Perez-Orribo L, Kalb S, Reyes PM, Chang SW, Crawford NR. Biomechanics of lumbar cortical screw-rod fixation versus pedicle screw-rod fixation with and without interbody support. Spine (Phila Pa 1976). 2013 Apr 15;38(8):635-41. doi: 10.1097/BRS.0b013e31827 — View Citation

Resnick DK, Choudhri TF, Dailey AT, Groff MW, Khoo L, Matz PG, Mummaneni P, Watters WC 3rd, Wang J, Walters BC, Hadley MN; American Association of Neurological Surgeons/Congress of Neurological Surgeons. Guidelines for the performance of fusion procedures — View Citation

Rouben D, Casnellie M, Ferguson M. Long-term durability of minimal invasive posterior transforaminal lumbar interbody fusion: a clinical and radiographic follow-up. J Spinal Disord Tech. 2011 Jul;24(5):288-96. doi: 10.1097/BSD.0b013e3181f9a60a. — View Citation

Santoni BG, Hynes RA, McGilvray KC, Rodriguez-Canessa G, Lyons AS, Henson MA, Womack WJ, Puttlitz CM. Cortical bone trajectory for lumbar pedicle screws. Spine J. 2009 May;9(5):366-73. doi: 10.1016/j.spinee.2008.07.008. Epub 2008 Sep 14. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale(VAS)	pain score	up to 36 months
Secondary	Oswestry Disability Index (ODI)	The Oswestry Disability Index pain score	up to 48 months
Secondary	Symptomatic adjacent-segment disease (SASD)	Symptomatic adjacent-segment disease rate	up to 48 months
Secondary	Japanese Orthopedic Association (JOA)	Japanese Orthopedic Association score	up to 48 months