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| Name | Class |
|---|---|
| Nexxt Spine, LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D-printed titanium cage | Active Comparator | Subjects enrolled in this arm will have the Nexxt Spine Nexxt MatrixxTM 3D-printed titanium cage (interbody cage) implanted at each level of 1 or 2-level lumbar arthrodesis procedures. All constructs will be supplemented with a pedicle screw system (Depuy Synthes Expedium) cleared for lumbar spinal fusion. |
|
| Poly-ether-ether-ketone (PEEK) cage | Active Comparator | Subjects enrolled in this arm will have the HonourTM poly-ether-ether-ketone (PEEK) cage (interbody cage) implanted at each level of 1 or 2-level lumbar arthrodesis procedures. All constructs will be supplemented with a pedicle screw system (Depuy Synthes Expedium) cleared for lumbar spinal fusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interbody cage (titanium) | Device | Subject will be implanted with a 3D-printed titanium cage during their lumbar interbody fusion surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shelby Miracle | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16688045 | Background | 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. | |
| 1471005 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 3D-printed Titanium Cage | Subjects enrolled in this arm will have the Nexxt Spine Nexxt MatrixxTM 3D-printed titanium cage (interbody cage) implanted at each level of 1 or 2-level lumbar arthrodesis procedures. All constructs will be supplemented with a pedicle screw system (Depuy Synthes Expedium) cleared for lumbar spinal fusion. Interbody cage (titanium): Subject will be implanted with a 3D-printed titanium cage during their lumbar interbody fusion surgery. |
| FG001 | Poly-ether-ether-ketone (PEEK) Cage | Subjects enrolled in this arm will have the HonourTM poly-ether-ether-ketone (PEEK) cage (interbody cage) implanted at each level of 1 or 2-level lumbar arthrodesis procedures. All constructs will be supplemented with a pedicle screw system (Depuy Synthes Expedium) cleared for lumbar spinal fusion. Interbody cage (PEEK): Subject will be implanted with a poly-ether-ether-ketone (PEEK) cage during their lumbar interbody fusion surgery. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 3D-printed Titanium Cage | Subjects enrolled in this arm will have the Nexxt Spine Nexxt MatrixxTM 3D-printed titanium cage (interbody cage) implanted at each level of 1 or 2-level lumbar arthrodesis procedures. All constructs will be supplemented with a pedicle screw system (Depuy Synthes Expedium) cleared for lumbar spinal fusion. Interbody cage (titanium): Subject will be implanted with a 3D-printed titanium cage during their lumbar interbody fusion surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | Cages/Spinal Levels | 6 months post-operatively | Fusion Levels (Number of cages used) | Fusion Levels (Number of cages used) |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 3D-printed Titanium Cage | Subjects enrolled in this arm will have the Nexxt Spine Nexxt MatrixxTM 3D-printed titanium cage (interbody cage) implanted at each level of 1 or 2-level lumbar arthrodesis procedures. All constructs will be supplemented with a pedicle screw system (Depuy Synthes Expedium) cleared for lumbar spinal fusion. Interbody cage (titanium): Subject will be implanted with a 3D-printed titanium cage during their lumbar interbody fusion surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea, lactic acidosis | Blood and lymphatic system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Subjective reporting of increased or new back pain without specific mention of leg pain |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shelby Miracle | The Ohio State University | 614-366-1648 | shelby.miracle@osumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 9, 2021 | Mar 1, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 9, 2021 | Mar 1, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D013130 | Spinal Stenosis |
| D013168 | Spondylolisthesis |
| D055009 | Spondylosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
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All 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.
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Subjects will be blinded to their group status for the duration of the study assessments and procedures (up to 24 months post-operatively).
| Interbody cage (PEEK) | Device | Subject will be implanted with a poly-ether-ether-ketone (PEEK) cage during their lumbar interbody fusion surgery. |
|
| 12045508 | Background | 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. |
| 15046896 | Background | 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. |
| 18037353 | Background | 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. |
| 15860204 | Background | 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. |
| 17686513 | Background | 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. |
| 16359252 | Background | 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. |
| 6374708 | Background | 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. |
| 21369477 | Background | 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. |
| 17367852 | Background | 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. |
| Background | Millennium Research Group (MRG) US Markets for Spinal Implants 2013 |
| 17846544 | Background | 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. |
| 25015180 | Background | 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. |
| 23684238 | Background | 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. |
| 18839226 | Background | 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. |
| 12768137 | Background | 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. |
| 2809818 | Background | Younger EM, Chapman MW. Morbidity at bone graft donor sites. J Orthop Trauma. 1989;3(3):192-5. doi: 10.1097/00005131-198909000-00002. |
| 37542447 | Derived | Toop N, Dhaliwal J, Gifford CS, Gibbs D, Keister A, Miracle S, Forghani R, Grossbach AJ, Farhadi HF. Promotion of higher rates of early fusion using activated titanium versus polyetheretherketone cages in adults undergoing 1- and 2-level transforaminal lumbar interbody fusion procedures: a randomized controlled trial. J Neurosurg Spine. 2023 Aug 4;39(5):709-718. doi: 10.3171/2023.6.SPINE23382. Print 2023 Nov 1. |
| BG001 | Poly-ether-ether-ketone (PEEK) Cage | Subjects enrolled in this arm will have the HonourTM poly-ether-ether-ketone (PEEK) cage (interbody cage) implanted at each level of 1 or 2-level lumbar arthrodesis procedures. All constructs will be supplemented with a pedicle screw system (Depuy Synthes Expedium) cleared for lumbar spinal fusion. Interbody cage (PEEK): Subject will be implanted with a poly-ether-ether-ketone (PEEK) cage during their lumbar interbody fusion surgery. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Current Smoker | Count of Participants | Participants |
|
| OG001 | Poly-ether-ether-ketone (PEEK) Cage | Subjects enrolled in this arm will have the HonourTM poly-ether-ether-ketone (PEEK) cage (interbody cage) implanted at each level of 1 or 2-level lumbar arthrodesis procedures. All constructs will be supplemented with a pedicle screw system (Depuy Synthes Expedium) cleared for lumbar spinal fusion. Interbody cage (PEEK): Subject will be implanted with a poly-ether-ether-ketone (PEEK) cage during their lumbar interbody fusion surgery. |
|
|
| 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. | Overall Number of Participants and Units Analyzed relied on available imaging at one year: Flexion extension films at one year were available for 18 (69.2%) PEEK patients and 16 (66.7%) of titanium patients. | Posted | Number | Surgical Levels | 12 months post-operatively | Surgical Levels | Surgical Levels |
|
|
|
| 0 |
| 25 |
| 7 |
| 25 |
| 3 |
| 25 |
| EG001 | Poly-ether-ether-ketone (PEEK) Cage | Subjects enrolled in this arm will have the HonourTM poly-ether-ether-ketone (PEEK) cage (interbody cage) implanted at each level of 1 or 2-level lumbar arthrodesis procedures. All constructs will be supplemented with a pedicle screw system (Depuy Synthes Expedium) cleared for lumbar spinal fusion. Interbody cage (PEEK): Subject will be implanted with a poly-ether-ether-ketone (PEEK) cage during their lumbar interbody fusion surgery. | 0 | 28 | 6 | 28 | 9 | 28 |
| cellulitis or gout flair up | Infections and infestations | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Syncope, Fall | General disorders | Non-systematic Assessment |
|
| Avulsed right bicep tendon - Repair | Surgical and medical procedures | Non-systematic Assessment |
|
| thyroidectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| wound dehiscense | Infections and infestations | Non-systematic Assessment | Wound revision surgery |
|
| acute encephalopathy | Nervous system disorders | Non-systematic Assessment | No acute stroke or brain mass. MRI showed white matter lesions that may be old and ischemic/gliotic in etiology related to small vessel disease. |
|
| inguinal hernia repair with mesh | Surgical and medical procedures | Non-systematic Assessment |
|
| Joint Pain and Swelling | General disorders | Non-systematic Assessment |
|
| Cardiac Catheterization/ Coronary Bypass Graft | Cardiac disorders | Non-systematic Assessment | Chest Pain |
|
|
| Symptomatic Radiculopathy - Back and Leg Pain | Nervous system disorders | Non-systematic Assessment | Reports of back pain with radiation to lower extremities |
|
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