Lumbar Fusion With Nexxt Spine 3D-Printed Titanium Interbody Cages

Lumbar Spinal Stenosis Clinical Trial

Official title:

Lumbar Fusion With 3D-Printed Porous Titanium Interbody Cages - A Single-Blinded Randomized Controlled Trial Evaluating Nexxt Matrixx(TM) Versus PEEK Cages

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03647501
• Other study ID #: 2018H0008
• Status: Completed
• Phase: N/A
• Start date: August 22, 2018
• Est. completion date: March 16, 2022

Study information

• Verified date: May 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this randomized controlled trial is to assess and compare radiographic and clinical outcomes in patients who are to undergo combined interbody/posterolateral lumbar fusion procedures, supplemented with pedicle screw instrumentation, using one of the following interbody cages; the Nexxt Spine Nexxt MatrixxTM 3D-printed titanium cage or the HonourTM poly-ether-ether-ketone cage.

Description:

This randomized controlled trial will prospectively evaluate the safety and efficacy of the Nexxt MatrixxTM System titanium implant supplemented with a pedicle screw system as compared to a representative PEEK cage currently used in routine fashion for lumbar interbody fusion procedures. This study will capture clinical and radiographic outcomes on patients up to 2 years post operatively. Both cages will be used in conjunction with milled local autograft bone generated as part of the spinal fusion procedure (no iliac crest autograft will be utilized).

This single centered study will enroll up to 70 subjects (n = 35 per group), with subjects followed for 24 months post-surgery. All subjects enrolled in the study will be recruited from a pool of subjects eligible for combined interbody/posterolateral lumbar fusion surgery.

Subjects will be randomized in the trial to receive either the Nexxt Spine Nexxt MatrixxTM 3D-printed titanium cage or the HonourTM PEEK cage supplemented with a pedicle screw system and milled local autograft bone. Subject randomization will be stratified according to smoking status. Subjects will be blinded to their group status for the duration of the study assessments and procedures (24 months post-operatively). Subject study data will be collected preoperatively, intra-operatively and postoperatively at 3, 6, 12, and 24 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: March 16, 2022
• Est. primary completion date: March 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is scheduled to undergo combined interbody and posterolateral spinal fusion surgery using either the Nexxt MatrixxTM 3D-printed titanium cage or HonourTM PEEK cage in conjunction with local autograft bone, and supplementation with a pedicle screw system.

• Subject must be over the age of 18 years old.

• Subject has been unresponsive to conservative care for a minimum of 6 months.

• The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.

Exclusion Criteria:

• Subjects with previous lumbar arthrodesis surgery.

• Subjects requiring additional bone grafting materials other than local autograft bone.

• Subject has inadequate tissue coverage over the operative site.

• Subject has an open wound local to the operative area, or rapid joint disease, bone absorption, or osteoporosis.

• Subject has a condition requiring medications that may interfere with bone or soft tissue healing (i.e., oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.).

• Subject has an active local or systemic infection.

• Subject has a metal sensitivity/foreign body sensitivity.

• Subject is morbidly obese, defined as a body mass index (BMI) greater than 40.

• Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study.

• Subject is currently involved in another investigational drug or device study that could confound study data.

• Subject has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up.

• Subjects who are pregnant or plan to become pregnant in the next 12 months or who are lactating.

• Subject is involved in or planning to engage in litigation or receiving Worker's Compensation related to neck or back pain.

• Subject is a prisoner.

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Lumbar Degenerative Disc Disease
• Lumbar Spinal Deformity
• Lumbar Spinal Stenosis
• Lumbar Spondylolisthesis
• Lumbar Spondylosis
• Spinal Stenosis
• Spondylolisthesis
• Spondylosis

Intervention

Device:
• Interbody cage (titanium)
Subject will be implanted with a 3D-printed titanium cage during their lumbar interbody fusion surgery.
• Interbody cage (PEEK)
Subject will be implanted with a poly-ether-ether-ketone (PEEK) cage during their lumbar interbody fusion surgery.

Locations

Country	Name	City	State
United States	Shelby Miracle	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Nexxt Spine, LLC

Country where clinical trial is conducted

United States, 

References & Publications (18)

Anjarwalla NK, Morcom RK, Fraser RD. Supplementary stabilization with anterior lumbar intervertebral fusion--a radiologic review. Spine (Phila Pa 1976). 2006 May 15;31(11):1281-7. doi: 10.1097/01.brs.0000217692.90624.ab. — View Citation

Fernyhough JC, Schimandle JJ, Weigel MC, Edwards CC, Levine AM. Chronic donor site pain complicating bone graft harvesting from the posterior iliac crest for spinal fusion. Spine (Phila Pa 1976). 1992 Dec;17(12):1474-80. doi: 10.1097/00007632-199212000-00006. — View Citation

Fritzell P, Hagg O, Wessberg P, Nordwall A; Swedish Lumbar Spine Study Group. Chronic low back pain and fusion: a comparison of three surgical techniques: a prospective multicenter randomized study from the Swedish lumbar spine study group. Spine (Phila Pa 1976). 2002 Jun 1;27(11):1131-41. doi: 10.1097/00007632-200206010-00002. — View Citation

Gotz HE, Muller M, Emmel A, Holzwarth U, Erben RG, Stangl R. Effect of surface finish on the osseointegration of laser-treated titanium alloy implants. Biomaterials. 2004 Aug;25(18):4057-64. doi: 10.1016/j.biomaterials.2003.11.002. — View Citation

Hangai M, Kaneoka K, Kuno S, Hinotsu S, Sakane M, Mamizuka N, Sakai S, Ochiai N. Factors associated with lumbar intervertebral disc degeneration in the elderly. Spine J. 2008 Sep-Oct;8(5):732-40. doi: 10.1016/j.spinee.2007.07.392. Epub 2007 Nov 26. — View Citation

Karageorgiou V, Kaplan D. Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials. 2005 Sep;26(27):5474-91. doi: 10.1016/j.biomaterials.2005.02.002. — View Citation

Kurtz SM, Devine JN. PEEK biomaterials in trauma, orthopedic, and spinal implants. Biomaterials. 2007 Nov;28(32):4845-69. doi: 10.1016/j.biomaterials.2007.07.013. Epub 2007 Aug 7. — View Citation

Laurencin C, Khan Y, El-Amin SF. Bone graft substitutes. Expert Rev Med Devices. 2006 Jan;3(1):49-57. doi: 10.1586/17434440.3.1.49. — View Citation

Laurie SW, Kaban LB, Mulliken JB, Murray JE. Donor-site morbidity after harvesting rib and iliac bone. Plast Reconstr Surg. 1984 Jun;73(6):933-8. doi: 10.1097/00006534-198406000-00014. — View Citation

Lee CS, Hwang CJ, Lee DH, Kim YT, Lee HS. Fusion rates of instrumented lumbar spinal arthrodesis according to surgical approach: a systematic review of randomized trials. Clin Orthop Surg. 2011 Mar;3(1):39-47. doi: 10.4055/cios.2011.3.1.39. Epub 2011 Feb 15. — View Citation

Li JP, Habibovic P, van den Doel M, Wilson CE, de Wijn JR, van Blitterswijk CA, de Groot K. Bone ingrowth in porous titanium implants produced by 3D fiber deposition. Biomaterials. 2007 Jun;28(18):2810-20. doi: 10.1016/j.biomaterials.2007.02.020. Epub 2007 Mar 23. — View Citation

Millennium Research Group (MRG) US Markets for Spinal Implants 2013

Nakada H, Sakae T, LeGeros RZ, LeGeros JP, Suwa T, Numata Y, Kobayashi K. Early tissue response to modified implant surfaces using back scattered imaging. Implant Dent. 2007 Sep;16(3):281-9. doi: 10.1097/ID.0b013e3180e92a78. — View Citation

Nemoto O, Asazuma T, Yato Y, Imabayashi H, Yasuoka H, Fujikawa A. Comparison of fusion rates following transforaminal lumbar interbody fusion using polyetheretherketone cages or titanium cages with transpedicular instrumentation. Eur Spine J. 2014 Oct;23(10):2150-5. doi: 10.1007/s00586-014-3466-9. Epub 2014 Jul 12. — View Citation

Olivares-Navarrete R, Hyzy SL, Gittens RA 1st, Schneider JM, Haithcock DA, Ullrich PF, Slosar PJ, Schwartz Z, Boyan BD. Rough titanium alloys regulate osteoblast production of angiogenic factors. Spine J. 2013 Nov;13(11):1563-70. doi: 10.1016/j.spinee.2013.03.047. Epub 2013 May 14. — View Citation

Quint U, Wilke HJ. Grading of degenerative disk disease and functional impairment: imaging versus patho-anatomical findings. Eur Spine J. 2008 Dec;17(12):1705-13. doi: 10.1007/s00586-008-0787-6. Epub 2008 Oct 7. — View Citation

Santos ER, Goss DG, Morcom RK, Fraser RD. Radiologic assessment of interbody fusion using carbon fiber cages. Spine (Phila Pa 1976). 2003 May 15;28(10):997-1001. doi: 10.1097/01.BRS.0000061988.93175.74. — View Citation

Younger EM, Chapman MW. Morbidity at bone graft donor sites. J Orthop Trauma. 1989;3(3):192-5. doi: 10.1097/00005131-198909000-00002. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interbody Radiographic Fusion Rate	Interbody fusion will be graded using the Brantigan, Steffee, Fraser (BSF) Scale which classifies fusion between the interbody cage and adjacent bone on a scale of 1-3 where a higher score indicates a better outcome. The grades are defined as follows: Brantigan, Steffee, Fraser-Grade 1 (BSF-1) indicates radiographical pseudarthrosis, Brantigan, Steffee, Fraser-Grade 2 (BSF-2) is defined by radiographical locked pseudarthrosis, and Brantigan, Steffee, Fraser-Grade 3 (BSF-3) is radiographical fusion, indicating the best outcome. The subject will be considered a success if fusion is a Grade BSF-3 at 6 months.	6 months post-operatively
Secondary	Post-operative Timing of Fusion	Secondary measures of effectiveness will be determined by timing of fusion observed in X-rays post-operatively. Fusion at one year was defined as a difference in cobb angle of the operated levels between flexion and extension views. More than 2 degrees of change between views indicated non-union at one year.	12 months post-operatively