Adverse Events Clinical Trial
Official title:
ABM/P-15 Bone Graft vs Traditional Bone Graft in Adult Spinal Deformity Surgery - a Randomized Controlled Clinical Trial
The purpose of this prospective trial is to investigate ABM/P-15 bone graft versus traditional bone graft in patients undergoing surgery for Adult Spinal Deformity (ASD) in order to provide better clinical results through faster bone healing, no additional surgeries, fewer complications and thereby increase health-related quality of life. Main hypotheses: 1. The use of ABM/P-15 bone graft is superior to traditional bone graft treatment regarding the incidence of additional surgeries following index surgery for ASD Secondary hypotheses: 2. The investigators expect non-inferiority in patient reported outcome measures in the ABM/P-15 bone graft group compared to the control group 3. The investigators expect non-inferiority in the postoperative fusion rates (bone healing) evaluated on CT scans in the ABM/P-15 bone graft group compared to the control group 4. The investigators expect non-inferiority in postoperative incidence of asymptomatic pseudarthrosis in the ABM/P-15 bone graft group compared to the control group 5. The investigators expect non-inferiority in perioperative complications in ABM/P-15 bone graft group compared to the control group 6. The investigators expect the use of ABM/P-15 bone graft to be cost-efficient compared to the traditional treatment in the control group
Status | Recruiting |
Enrollment | 240 |
Est. completion date | October 1, 2027 |
Est. primary completion date | October 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Indication for ASD surgery - Indication for the use of bone graft - Age = 18 years old at the date of surgery Exclusion Criteria: - ASA = 4 - Formally diagnosed with a disease affecting the bone metabolism or wound healing (severe osteoporosis, osteomalacia, Pagets disease, hyperparathyreoidism etc.) - Disseminated cancer diseases - Hypersensitivity to any of the i-FACTOR Peptide Enhanced Bone Graft ingredients - Smoking, extensive alcohol use or abuse of hallucinating drugs - Severe liver or kidney disorders - Pregnancy or breastfeeding patients - Patients estimated not to be able to understand the information sheet or patients, who do not consent to participate in the study. - Severe psychiatric diseases - Ongoing infections |
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet, Department of Orthopedics, Spine Unit | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | CeraPedics, Inc |
Denmark,
Alvin MD, Miller JA, Lubelski D, Rosenbaum BP, Abdullah KG, Whitmore RG, Benzel EC, Mroz TE. Variations in cost calculations in spine surgery cost-effectiveness research. Neurosurg Focus. 2014 Jun;36(6):E1. doi: 10.3171/2014.3.FOCUS1447. — View Citation
Arnold PM, Sasso RC, Janssen ME, Fehlings MG, Heary RF, Vaccaro AR, Kopjar B. i-Factor Bone Graft vs Autograft in Anterior Cervical Discectomy and Fusion: 2-Year Follow-up of the Randomized Single-Blinded Food and Drug Administration Investigational Device Exemption Study. Neurosurgery. 2018 Sep 1;83(3):377-384. doi: 10.1093/neuros/nyx432. — View Citation
Arnold PM, Sasso RC, Janssen ME, Fehlings MG, Smucker JD, Vaccaro AR, Heary RF, Patel AI, Goulet B, Kalfas IH, Kopjar B. Efficacy of i-Factor Bone Graft versus Autograft in Anterior Cervical Discectomy and Fusion: Results of the Prospective, Randomized, Single-blinded Food and Drug Administration Investigational Device Exemption Study. Spine (Phila Pa 1976). 2016 Jul 1;41(13):1075-1083. doi: 10.1097/BRS.0000000000001466. — View Citation
Arutyunyan GG, Angevine PD, Berven S. Cost-Effectiveness in Adult Spinal Deformity Surgery. Neurosurgery. 2018 Oct 1;83(4):597-601. doi: 10.1093/neuros/nyx575. Erratum In: Neurosurgery. 2019 Mar 1;84(3):815. — View Citation
Axelsen MG, Overgaard S, Jespersen SM, Ding M. Comparison of synthetic bone graft ABM/P-15 and allograft on uninstrumented posterior lumbar spine fusion in sheep. J Orthop Surg Res. 2019 Jan 3;14(1):2. doi: 10.1186/s13018-018-1042-4. — View Citation
Bari TJ, Hansen LV, Gehrchen M. Surgical correction of Adult Spinal Deformity in accordance to the Roussouly classification: effect on postoperative mechanical complications. Spine Deform. 2020 Oct;8(5):1027-1037. doi: 10.1007/s43390-020-00112-6. Epub 2020 Apr 11. — View Citation
Barros RR, Novaes AB Jr, Roriz VM, Oliveira RR, Grisi MF, Souza SL, Taba M Jr, Palioto DB. Anorganic bovine matrix/p-15 "flow" in the treatment of periodontal defects: case series with 12 months of follow-up. J Periodontol. 2006 Jul;77(7):1280-7. doi: 10.1902/jop.2006.050161. — View Citation
Blanco JS, Sears CJ. Allograft bone use during instrumentation and fusion in the treatment of adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 1997 Jun 15;22(12):1338-42. doi: 10.1097/00007632-199706150-00011. — View Citation
Brantigan JW, Steffee AD, Lewis ML, Quinn LM, Persenaire JM. Lumbar interbody fusion using the Brantigan I/F cage for posterior lumbar interbody fusion and the variable pedicle screw placement system: two-year results from a Food and Drug Administration investigational device exemption clinical trial. Spine (Phila Pa 1976). 2000 Jun 1;25(11):1437-46. doi: 10.1097/00007632-200006010-00017. — View Citation
Burkus JK, Gornet MF, Schuler TC, Kleeman TJ, Zdeblick TA. Six-year outcomes of anterior lumbar interbody arthrodesis with use of interbody fusion cages and recombinant human bone morphogenetic protein-2. J Bone Joint Surg Am. 2009 May;91(5):1181-9. doi: 10.2106/JBJS.G.01485. — View Citation
Cheng I, Oshtory R, Wildstein MS. The role of osteobiologics in spinal deformity. Neurosurg Clin N Am. 2007 Apr;18(2):393-401. doi: 10.1016/j.nec.2007.01.002. — View Citation
Daubs MD, Lenke LG, Cheh G, Stobbs G, Bridwell KH. Adult spinal deformity surgery: complications and outcomes in patients over age 60. Spine (Phila Pa 1976). 2007 Sep 15;32(20):2238-44. doi: 10.1097/BRS.0b013e31814cf24a. — View Citation
Diebo BG, Shah NV, Boachie-Adjei O, Zhu F, Rothenfluh DA, Paulino CB, Schwab FJ, Lafage V. Adult spinal deformity. Lancet. 2019 Jul 13;394(10193):160-172. doi: 10.1016/S0140-6736(19)31125-0. Epub 2019 Jul 11. — View Citation
Ehrler DM, Vaccaro AR. The use of allograft bone in lumbar spine surgery. Clin Orthop Relat Res. 2000 Feb;(371):38-45. doi: 10.1097/00003086-200002000-00005. — View Citation
Emecen P, Akman AC, Hakki SS, Hakki EE, Demiralp B, Tozum TF, Nohutcu RM. ABM/P-15 modulates proliferation and mRNA synthesis of growth factors of periodontal ligament cells. Acta Odontol Scand. 2009;67(2):65-73. doi: 10.1080/00016350802555525. — View Citation
Fatima G, Shivamurthy R, Thakur S, Baseer MA. Evaluation of anorganic bovine-derived hydroxyapatite matrix/cell binding peptide as a bone graft material in the treatment of human periodontal infrabony defects: A clinico-radiographic study. J Indian Soc Periodontol. 2015 Nov-Dec;19(6):651-8. doi: 10.4103/0972-124X.164766. — View Citation
Giannoudis PV, Dinopoulos H, Tsiridis E. Bone substitutes: an update. Injury. 2005 Nov;36 Suppl 3:S20-7. doi: 10.1016/j.injury.2005.07.029. — View Citation
Glassman SD, Bridwell K, Dimar JR, Horton W, Berven S, Schwab F. The impact of positive sagittal balance in adult spinal deformity. Spine (Phila Pa 1976). 2005 Sep 15;30(18):2024-9. doi: 10.1097/01.brs.0000179086.30449.96. — View Citation
Gomar F, Orozco R, Villar JL, Arrizabalaga F. P-15 small peptide bone graft substitute in the treatment of non-unions and delayed union. A pilot clinical trial. Int Orthop. 2007 Feb;31(1):93-9. doi: 10.1007/s00264-006-0087-x. Epub 2006 Jun 8. — View Citation
Good CR, Auerbach JD, O'Leary PT, Schuler TC. Adult spine deformity. Curr Rev Musculoskelet Med. 2011 Dec;4(4):159-67. doi: 10.1007/s12178-011-9101-z. — View Citation
Hellsten EK, Hanbidge MA, Manos AN, Lewis SJ, Massicotte EM, Fehlings MG, Coyte PC, Rampersaud YR. An economic evaluation of perioperative adverse events associated with spinal surgery. Spine J. 2013 Jan;13(1):44-53. doi: 10.1016/j.spinee.2013.01.003. — View Citation
Jacobsen MK, Andresen AK, Jespersen AB, Stottrup C, Carreon LY, Overgaard S, Andersen MO. Randomized double blind clinical trial of ABM/P-15 versus allograft in noninstrumented lumbar fusion surgery. Spine J. 2020 May;20(5):677-684. doi: 10.1016/j.spinee.2020.01.009. Epub 2020 Jan 28. — View Citation
Kadam A, Millhouse PW, Kepler CK, Radcliff KE, Fehlings MG, Janssen ME, Sasso RC, Benedict JJ, Vaccaro AR. Bone substitutes and expanders in Spine Surgery: A review of their fusion efficacies. Int J Spine Surg. 2016 Sep 22;10:33. doi: 10.14444/3033. eCollection 2016. — View Citation
Kannan A, Dodwad SN, Hsu WK. Biologics in spine arthrodesis. J Spinal Disord Tech. 2015 Jun;28(5):163-70. doi: 10.1097/BSD.0000000000000281. — View Citation
Karstensen S, Bari T, Gehrchen M, Street J, Dahl B. Morbidity and mortality of complex spine surgery: a prospective cohort study in 679 patients validating the Spine AdVerse Event Severity (SAVES) system in a European population. Spine J. 2016 Feb;16(2):146-53. doi: 10.1016/j.spinee.2015.09.051. Epub 2015 Oct 8. — View Citation
Kirzner N, Hilliard L, Martin C, Quan G, Liew S, Humadi A. Bone graft in posterior spine fusion for adolescent idiopathic scoliosis: a meta-analysis. ANZ J Surg. 2018 Dec;88(12):1247-1252. doi: 10.1111/ans.14551. Epub 2018 May 15. — View Citation
Kubler A, Neugebauer J, Oh JH, Scheer M, Zoller JE. Growth and proliferation of human osteoblasts on different bone graft substitutes: an in vitro study. Implant Dent. 2004 Jun;13(2):171-9. doi: 10.1097/01.id.0000127522.14067.11. — View Citation
Lau D, Clark AJ, Scheer JK, Daubs MD, Coe JD, Paonessa KJ, LaGrone MO, Kasten MD, Amaral RA, Trobisch PD, Lee JH, Fabris-Monterumici D, Anand N, Cree AK, Hart RA, Hey LA, Ames CP; SRS Adult Spinal Deformity Committee. Proximal junctional kyphosis and failure after spinal deformity surgery: a systematic review of the literature as a background to classification development. Spine (Phila Pa 1976). 2014 Dec 1;39(25):2093-102. doi: 10.1097/BRS.0000000000000627. — View Citation
Lauweryns P, Raskin Y. Prospective analysis of a new bone graft in lumbar interbody fusion: results of a 2- year prospective clinical and radiological study. Int J Spine Surg. 2015 Feb 3;9:2. doi: 10.14444/2002. eCollection 2015. — View Citation
Loenen ACY, Connor J, Johnson S, Davis K, Hannigan N, Barnes T, Arts JJ, van Rietbergen B. Peptide Enhanced Bone Graft Substitute Presents Improved Short-Term Increase in Bone Volume and Construct Stiffness Compared to Iliac Crest Autologous Bone in an Ovine Lumbar Interbody Fusion Model. Global Spine J. 2022 Sep;12(7):1330-1337. doi: 10.1177/2192568220979839. Epub 2021 Jan 7. — View Citation
McCarthy I, Hostin R, O'Brien M, Saigal R, Ames CP. Health economic analysis of adult deformity surgery. Neurosurg Clin N Am. 2013 Apr;24(2):293-304. doi: 10.1016/j.nec.2012.12.005. Epub 2013 Feb 21. — View Citation
Mishra PRN, Kolte AP, Kolte RA, Pajnigara NG, Shah KK. Comparative evaluation of open flap debridement alone and in combination with anorganic bone matrix/cell-binding peptide in the treatment of human infrabony defects: A randomized clinical trial. J Indian Soc Periodontol. 2019 Jan-Feb;23(1):42-47. doi: 10.4103/jisp.jisp_339_18. — View Citation
Mobbs RJ, Maharaj M, Rao PJ. Clinical outcomes and fusion rates following anterior lumbar interbody fusion with bone graft substitute i-FACTOR, an anorganic bone matrix/P-15 composite. J Neurosurg Spine. 2014 Dec;21(6):867-76. doi: 10.3171/2014.9.SPINE131151. Epub 2014 Oct 17. — View Citation
MOE JH. A critical analysis of methods of fusion for scoliosis; an evaluation in two hundred and sixty-six patients. J Bone Joint Surg Am. 1958 Jun;40-A(3):529-54 passim. No abstract available. — View Citation
Mroz TE, Joyce MJ, Lieberman IH, Steinmetz MP, Benzel EC, Wang JC. The use of allograft bone in spine surgery: is it safe? Spine J. 2009 Apr;9(4):303-8. doi: 10.1016/j.spinee.2008.06.452. Epub 2008 Sep 19. — View Citation
Ni J, Zheng Y, Liu N, Wang X, Fang X, Phukan R, Wood KB. Radiological evaluation of anterior lumbar fusion using PEEK cages with adjacent vertebral autograft in spinal deformity long fusion surgeries. Eur Spine J. 2015 Apr;24(4):791-9. doi: 10.1007/s00586-014-3745-5. Epub 2015 Jan 25. — View Citation
Pape HC, Evans A, Kobbe P. Autologous bone graft: properties and techniques. J Orthop Trauma. 2010 Mar;24 Suppl 1:S36-40. doi: 10.1097/BOT.0b013e3181cec4a1. — View Citation
Pellise F, Vila-Casademunt A, Ferrer M, Domingo-Sabat M, Bago J, Perez-Grueso FJ, Alanay A, Mannion AF, Acaroglu E; European Spine Study Group, ESSG. Impact on health related quality of life of adult spinal deformity (ASD) compared with other chronic conditions. Eur Spine J. 2015 Jan;24(1):3-11. doi: 10.1007/s00586-014-3542-1. Epub 2014 Sep 14. — View Citation
Pitter FT, Lindberg-Larsen M, Pedersen AB, Dahl B, Gehrchen M. Revision Risk After Primary Adult Spinal Deformity Surgery: A Nationwide Study With Two-Year Follow-up. Spine Deform. 2019 Jul;7(4):619-626.e2. doi: 10.1016/j.jspd.2018.10.006. — View Citation
Qian JJ, Bhatnagar RS. Enhanced cell attachment to anorganic bone mineral in the presence of a synthetic peptide related to collagen. J Biomed Mater Res. 1996 Aug;31(4):545-54. doi: 10.1002/(SICI)1097-4636(199608)31:43.0.CO;2-F. — View Citation
Queiroz AC, Nobrega PB, Oliveira FS, Novaes AB Jr, Taba M Jr, Palioto DB, Grisi MF, Souza SL. Treatment of intrabony defects with anorganic bone matrix/p-15 or guided tissue regeneration in patients with aggressive periodontitis. Braz Dent J. 2013;24(3):204-12. doi: 10.1590/0103-6440201302169. — View Citation
Raman T, Nayar SK, Liu S, Skolasky RL, Kebaish KM. Cost-Effectiveness of Primary and Revision Surgery for Adult Spinal Deformity. Spine (Phila Pa 1976). 2018 Jun 1;43(11):791-797. doi: 10.1097/BRS.0000000000002481. — View Citation
Scheer JK, Oh T, Smith JS, Shaffrey CI, Daniels AH, Sciubba DM, Hamilton DK, Protopsaltis TS, Passias PG, Hart RA, Burton DC, Bess S, Lafage R, Lafage V, Schwab F, Klineberg EO, Ames CP; International Spine Study Group. Development of a validated computer-based preoperative predictive model for pseudarthrosis with 91% accuracy in 336 adult spinal deformity patients. Neurosurg Focus. 2018 Nov 1;45(5):E11. doi: 10.3171/2018.8.FOCUS18246. — View Citation
Shaikh MS, Husain S, Lone MA, Lone MA, Akhlaq H, Zafar MS. Clinical effectiveness of anorganic bovine-derived hydroxyapatite matrix/cell-binding peptide grafts for regeneration of periodontal defects: a systematic review and meta-analysis. Regen Med. 2020 Dec;15(12):2379-2395. doi: 10.2217/rme-2020-0113. Epub 2020 Dec 24. — View Citation
Sherman BP, Lindley EM, Turner AS, Seim HB 3rd, Benedict J, Burger EL, Patel VV. Evaluation of ABM/P-15 versus autogenous bone in an ovine lumbar interbody fusion model. Eur Spine J. 2010 Dec;19(12):2156-63. doi: 10.1007/s00586-010-1546-z. Epub 2010 Aug 9. — View Citation
Smith JS, Klineberg E, Lafage V, Shaffrey CI, Schwab F, Lafage R, Hostin R, Mundis GM Jr, Errico TJ, Kim HJ, Protopsaltis TS, Hamilton DK, Scheer JK, Soroceanu A, Kelly MP, Line B, Gupta M, Deviren V, Hart R, Burton DC, Bess S, Ames CP; International Spine Study Group. Prospective multicenter assessment of perioperative and minimum 2-year postoperative complication rates associated with adult spinal deformity surgery. J Neurosurg Spine. 2016 Jul;25(1):1-14. doi: 10.3171/2015.11.SPINE151036. Epub 2016 Feb 26. — View Citation
Smith JS, Shaffrey CI, Glassman SD, Berven SH, Schwab FJ, Hamill CL, Horton WC, Ondra SL, Sansur CA, Bridwell KH; Spinal Deformity Study Group. Risk-benefit assessment of surgery for adult scoliosis: an analysis based on patient age. Spine (Phila Pa 1976). 2011 May 1;36(10):817-24. doi: 10.1097/BRS.0b013e3181e21783. — View Citation
Strube P, Hoff E, Hartwig T, Perka CF, Gross C, Putzier M. Stand-alone anterior versus anteroposterior lumbar interbody single-level fusion after a mean follow-up of 41 months. J Spinal Disord Tech. 2012 Oct;25(7):362-9. doi: 10.1097/BSD.0b013e3182263d91. — View Citation
Yang XB, Bhatnagar RS, Li S, Oreffo RO. Biomimetic collagen scaffolds for human bone cell growth and differentiation. Tissue Eng. 2004 Jul-Aug;10(7-8):1148-59. doi: 10.1089/ten.2004.10.1148. — View Citation
Yeramaneni S, Robinson C, Hostin R. Impact of spine surgery complications on costs associated with management of adult spinal deformity. Curr Rev Musculoskelet Med. 2016 Sep;9(3):327-32. doi: 10.1007/s12178-016-9352-9. — View Citation
Yukna RA, Krauser JT, Callan DP, Evans GH, Cruz R, Martin M. Multi-center clinical comparison of combination anorganic bovine-derived hydroxyapatite matrix (ABM)/cell binding peptide (P-15) and ABM in human periodontal osseous defects. 6-month results. J Periodontol. 2000 Nov;71(11):1671-9. doi: 10.1902/jop.2000.71.11.1671. Erratum In: J Periodontol 2001 Apr;72(4):570. J Periodontol. 2001 Apr;72 (4):570. — View Citation
Yukna RA, Krauser JT, Callan DP, Evans GH, Cruz R, Martin M. Thirty-six month follow-up of 25 patients treated with combination anorganic bovine-derived hydroxyapatite matrix (ABM)/cell-binding peptide (P-15) bone replacement grafts in human infrabony defects. I. Clinical findings. J Periodontol. 2002 Jan;73(1):123-8. doi: 10.1902/jop.2002.73.1.123. — View Citation
* Note: There are 52 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The incidence of revision surgery | Incidence of revision surgery will be defined as revision surgery due to any of the following:
Implant failure (e.g rod breakage, screw breakage, cage displacement/subsidence) Pseudarthrosis assessed by CT-scan |
2 years postoperatively | |
Secondary | Patient reported outcome measures (PROMs) - VAS | Questionnaire: Visuel analog scale (VAS). Scale 1-10. 1 is no pain, 10 is max pain Minimal clinically important difference (MCID) will be used to assess any difference between groups based on previous reports | Preoperatively, immediate postoperatively, 1 year postoperatively, 2 years postoperatively | |
Secondary | Patient reported outcome measures (PROMs) - EQ-5D-3L | Questionnaire: European Quality of Life Five Dimension with 3 levels (EQ-5D-3L). Each question is scored from 1-3, where 3 is given if there are no problems.
Values will often be presented as a percentage of the total possible amount. The last question is a scale ranging from 1-100. 1 is worst quality of life, 100 is best quality of life Minimal clinically important difference (MCID) will be used to assess any difference between groups based on previous reports |
Preoperatively, immediate postoperatively, 1 year postoperatively, 2 years postoperatively | |
Secondary | Patient reported outcome measures (PROMs) - Danespine Deformity Basis | Questionnaire: Danespine deformity basis. Height and weight, walking ability rangin from normal to bound to the bed. Lastly, the questions is asked why they are undergoing surgery with 5 different options.
Minimal clinically important difference (MCID) will be used to assess any difference between groups based on previous reports |
Preoperatively, immediate postoperatively, 1 year postoperatively, 2 years postoperatively | |
Secondary | Patient reported outcome measures (PROMs) - SRS-22 | Questionnaire: Scoliosis Research Sociely Health-Related Quality of Life Questionnaire with 22 questions (SRS-22).
Each question is scored from 1-5, where 5 is given if there are no problems. Values will often be presented as a percentage of the total possible amount. Minimal clinically important difference (MCID) will be used to assess any difference between groups based on previous reports |
Preoperatively, immediate postoperatively, 1 year postoperatively, 2 years postoperatively | |
Secondary | Bone-to-bone fusion assessed on CT scans | Posterolateral fusion will be defined according to the Lenke fusion grading system (Type A-D). Type A and type B will be defined as having fusion, whereas type C and type D will be defined as non-fusion [48]. | 1 year postoperatively | |
Secondary | Incidence of asymptomatic pseudarthrosis using CT-scans | Radiographic signs of pseudarthrosis (in accordance to the above) in combinations with patient reported complaints, including pain, will be defined as symptomatic pseudarthrosis, and asymptomatic pseudarthrosis in cases of radiographic pseudarthrosis without patient reported complaints. | 1 year postoperatively | |
Secondary | Perioperative adverse events | All adverse events will be noted. | Intraoperatively, immediate postoperatively during admission, 1 year postoperatively, 2 years postoperatively | |
Secondary | Cost-effectiveness analysis | The overall cost per patient undergoing ASD surgery (incl. pre-, peri- and postoperative costs) can be estimated, using: diagnosis codes, procedural codes incl. supplemental codes in conjunction with data extraction from electronic medical records (Sundhedsplatformen). The total cost is calculated using diagnosis-related group (DRG) rates (this include for example: cystitis, pneumonia etc.). | 2 years postoperatively |
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