Evaluation of Cranioplasty Using Native Bone Autograft Versus Synthetic Bone Allograft

Surgical Procedure, Unspecified Clinical Trial

Official title:

Evaluation of Cranioplasty Using Native Bone Autograft Versus Synthetic Bone Allograft

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04855175
• Other study ID #: IRB#1682010
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2021
• Est. completion date: February 10, 2024

Study information

• Verified date: April 2021
• Source: LifeBridge Health
• Contact: William Ashley, MD, PhD, MBA
• Phone: 410-601-8166
• Email: washley[@]lifebridgehealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Elevated intracranial pressure (ICP) is a common neurosurgical emergency that may arise from several conditions, which cause an intracranial mass effect. In the case of conservatively refractory ICP elevation, one viable treatment option is ICP-lowering surgery, i.e., decompressive craniectomy (DC) in which a large portion of the skull bone is removed and the dura mater opened, creating more room for the brain tissue to expand and thus reducing the ICP. A successful CP will restore the contour of the cranium, protect the brain, and ensure a natural ICP, and some patients also show neurological improvement post-CP. Thus, CP has a great potential for improving the patient's quality of life.

Bone flap resorption (BFR) implies weakening and loosening of the autologous bone flap after reimplantation and is regarded as a late CP complication involving nonunion of the bone flap with the surrounding bone margins and cavity formation in the flap itself, which eventually necessitates removal of the bone flap and a new CP using a synthetic implant. These additional operations increase costs and necessitate further hospital stays, while rendering the patient vulnerable to additional complications.

Prior research performed as part of the FDA approval process has shown the ASPCI's to be a safe and effective means of performing cranial reconstruction, the anticipated risks do not differ from the risks faced by a patient undergoing either option as they are both currently considered standards of care.

This study will evaluate the overall patient outcomes of cranial reconstruction surgery using native bone autograft as compared to using synthetic bone allograft.

Description:

Elevated intracranial pressure (ICP) is a common neurosurgical emergency that may arise from several conditions, which cause an intracranial mass effect. In the case of conservatively refractory ICP elevation, one viable treatment option is ICP-lowering surgery, i.e., decompressive craniectomy (DC) in which a large portion of the skull bone is removed and the dura mater opened, creating more room for the brain tissue to expand and thus reducing the ICP. In many centers, the bone flap removed in DC is customarily kept deep frozen at -70°C until reimplantation during cranioplasty (CP). The cranium is repaired during CP by returning the previously removed autologous bone flap or by placing an artificial implant in the defect area. A successful CP will restore the contour of the cranium, protect the brain, and ensure a natural ICP, and some patients also show neurological improvement post-CP1-4. Thus, CP has a great potential for improving the patient's quality of life. Although widely regarded as a routine operation, CP often involves serious complications, such as postoperative hemorrhages, surgical site infection (SSI), and, most importantly, resorption of the autologous bone flap5-8.

Bone flap resorption (BFR) implies weakening and loosening of the autologous bone flap after reimplantation and is regarded as a late CP complication involving nonunion of the bone flap with the surrounding bone margins and cavity formation in the flap itself, which eventually necessitates removal of the bone flap and a new CP using a synthetic implant. These additional operations increase costs and necessitate further hospital stays, while rendering the patient vulnerable to additional complications. The reported prevalence of BFR with autologous CPs has varied significantly, from 1.4% to 32.0%, with infection rates ranging from 4.6% to 16.4%9-12.

CP is a common procedure for cranial reconstruction in the setting of trauma, stroke, skull neoplasm, osteomyelitis, or after procedures that are approached via craniectomy such as microvascular decompression or acoustic neuroma.

Recently there have been two major areas of interest presenting in the literature. First, there have been at least 6 manuscripts published on retrospective data comparing autologous bone versus synthetic prosthetic for CP13-18. Each has shown benefit for synthetic prosthetics. However, the community is resistant to implement a treatment pattern where synthetic bone is a "first line" choice for CP. Therefore, a prospective randomized controlled trial is needed to understand with high confidence the option that is most beneficial for patients.

Prior research performed as part of the FDA approval process has shown the ASPCI's to be a safe and effective means of performing cranial reconstruction, the anticipated risks do not differ from the risks faced by a patient undergoing either option as they are both currently considered standards of care.

This study will evaluate the overall patient outcomes of cranial reconstruction surgery using native bone autograft as compared to using synthetic bone allograft.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 10, 2024
• Est. primary completion date: February 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• All adult patients being considered for CP surgery by the investigating physician at the Life Bridge Health-Sinai Hospital of Baltimore

• Able to read and speak English, or have LAR who reads and speaks English

• Patients who need cranial reconstruction

Exclusion Criteria:

• Patients affected by comminuted skull fractures,

• Patients affected by osteomyelitis,

• Patients with skull neoplasm and therefore not be candidates for autologous CP

• Patients who would need to be allocated to one group over the other due to clinical presentation

Related Conditions & MeSH terms

• Surgical Procedure, Unspecified

Intervention

Device:
• Synthetic Bone Allograft (ClearFit)
Patients in this arm will receive ClearFit (synthetic bone allograft)

Other:
• Autograft
Patients in this arm will use patient's own bone

Locations

Country	Name	City	State
United States	Sinai Hospital of Baltimore	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
LifeBridge Health

Country where clinical trial is conducted

United States, 

References & Publications (24)

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Aydin S, Kucukyuruk B, Abuzayed B, Aydin S, Sanus GZ. Cranioplasty: Review of materials and techniques. J Neurosci Rural Pract. 2011 Jul;2(2):162-7. doi: 10.4103/0976-3147.83584. — View Citation

Chang V, Hartzfeld P, Langlois M, Mahmood A, Seyfried D. Outcomes of cranial repair after craniectomy. J Neurosurg. 2010 May;112(5):1120-4. doi: 10.3171/2009.6.JNS09133. — View Citation

Coelho F, Oliveira AM, Paiva WS, Freire FR, Calado VT, Amorim RL, Neville IS, de Andrade AF, Bor-Seng-Shu E, Anghinah R, Teixeira MJ. Comprehensive cognitive and cerebral hemodynamic evaluation after cranioplasty. Neuropsychiatr Dis Treat. 2014 May 2;10:695-701. doi: 10.2147/NDT.S52875. eCollection 2014. — View Citation

Di Stefano C, Rinaldesi ML, Quinquinio C, Ridolfi C, Vallasciani M, Sturiale C, Piperno R. Neuropsychological changes and cranioplasty: A group analysis. Brain Inj. 2016;30(2):164-71. doi: 10.3109/02699052.2015.1090013. Epub 2015 Dec 8. — View Citation

Gordon CR, Huang J, Brem H. Neuroplastic Surgery. J Craniofac Surg. 2018 Jan;29(1):4-5. doi: 10.1097/SCS.0000000000004063. — View Citation

Honeybul S, Janzen C, Kruger K, Ho KM. The impact of cranioplasty on neurological function. Br J Neurosurg. 2013 Oct;27(5):636-41. doi: 10.3109/02688697.2013.817532. Epub 2013 Jul 25. — View Citation

Huang GJ, Zhong S, Susarla SM, Swanson EW, Huang J, Gordon CR. Craniofacial reconstruction with poly(methyl methacrylate) customized cranial implants. J Craniofac Surg. 2015 Jan;26(1):64-70. doi: 10.1097/SCS.0000000000001315. — View Citation

Klinger DR, Madden C, Beshay J, White J, Gambrell K, Rickert K. Autologous and acrylic cranioplasty: a review of 10 years and 258 cases. World Neurosurg. 2014 Sep-Oct;82(3-4):e525-30. doi: 10.1016/j.wneu.2013.08.005. Epub 2013 Sep 13. Review. — View Citation

Korhonen TK, Tetri S, Huttunen J, Lindgren A, Piitulainen JM, Serlo W, Vallittu PK, Posti JP; Finnish National Cranial Implant Registry (FiNCIR) study group. Predictors of primary autograft cranioplasty survival and resorption after craniectomy. J Neurosurg. 2018 May 1:1-8. doi: 10.3171/2017.12.JNS172013. [Epub ahead of print] — View Citation

Lethaus B, Bloebaum M, Essers B, ter Laak MP, Steiner T, Kessler P. Patient-specific implants compared with stored bone grafts for patients with interval cranioplasty. J Craniofac Surg. 2014 Jan;25(1):206-9. doi: 10.1097/SCS.0000000000000396. — View Citation

Malcolm JG, Mahmooth Z, Rindler RS, Allen JW, Grossberg JA, Pradilla G, Ahmad FU. Autologous Cranioplasty is Associated with Increased Reoperation Rate: A Systematic Review and Meta-Analysis. World Neurosurg. 2018 Aug;116:60-68. doi: 10.1016/j.wneu.2018.05.009. Epub 2018 May 16. Review. — View Citation

Martin KD, Franz B, Kirsch M, Polanski W, von der Hagen M, Schackert G, Sobottka SB. Autologous bone flap cranioplasty following decompressive craniectomy is combined with a high complication rate in pediatric traumatic brain injury patients. Acta Neurochir (Wien). 2014 Apr;156(4):813-24. doi: 10.1007/s00701-014-2021-0. Epub 2014 Feb 16. — View Citation

Moreira-Gonzalez A, Jackson IT, Miyawaki T, Barakat K, DiNick V. Clinical outcome in cranioplasty: critical review in long-term follow-up. J Craniofac Surg. 2003 Mar;14(2):144-53. Erratum in: J Craniofac Surg. 2003 Sep;14(5):816. — View Citation

Pryor LS, Gage E, Langevin CJ, Herrera F, Breithaupt AD, Gordon CR, Afifi AM, Zins JE, Meltzer H, Gosman A, Cohen SR, Holmes R. Review of bone substitutes. Craniomaxillofac Trauma Reconstr. 2009 Oct;2(3):151-60. doi: 10.1055/s-0029-1224777. — View Citation

Schoekler B, Trummer M. Prediction parameters of bone flap resorption following cranioplasty with autologous bone. Clin Neurol Neurosurg. 2014 May;120:64-7. doi: 10.1016/j.clineuro.2014.02.014. Epub 2014 Feb 24. — View Citation

Segal DH, Oppenheim JS, Murovic JA. Neurological recovery after cranioplasty. Neurosurgery. 1994 Apr;34(4):729-31; discussion 731. — View Citation

Shahid AH, Mohanty M, Singla N, Mittal BR, Gupta SK. The effect of cranioplasty following decompressive craniectomy on cerebral blood perfusion, neurological, and cognitive outcome. J Neurosurg. 2018 Jan;128(1):229-235. doi: 10.3171/2016.10.JNS16678. Epub 2017 Mar 3. — View Citation

Stieglitz LH, Fung C, Murek M, Fichtner J, Raabe A, Beck J. What happens to the bone flap? Long-term outcome after reimplantation of cryoconserved bone flaps in a consecutive series of 92 patients. Acta Neurochir (Wien). 2015 Feb;157(2):275-80. doi: 10.1007/s00701-014-2310-7. Epub 2014 Dec 24. — View Citation

Sundseth J, Sundseth A, Berg-Johnsen J, Sorteberg W, Lindegaard KF. Cranioplasty with autologous cryopreserved bone after decompressive craniectomy: complications and risk factors for developing surgical site infection. Acta Neurochir (Wien). 2014 Apr;156(4):805-11; discussion 811. doi: 10.1007/s00701-013-1992-6. Epub 2014 Feb 4. — View Citation

van de Vijfeijken SECM, Münker TJAG, Spijker R, Karssemakers LHE, Vandertop WP, Becking AG, Ubbink DT; CranioSafe Group. Autologous Bone Is Inferior to Alloplastic Cranioplasties: Safety of Autograft and Allograft Materials for Cranioplasties, a Systematic Review. World Neurosurg. 2018 Sep;117:443-452.e8. doi: 10.1016/j.wneu.2018.05.193. Epub 2018 Jun 5. Review. — View Citation

Walcott BP, Kwon CS, Sheth SA, Fehnel CR, Koffie RM, Asaad WF, Nahed BV, Coumans JV. Predictors of cranioplasty complications in stroke and trauma patients. J Neurosurg. 2013 Apr;118(4):757-62. doi: 10.3171/2013.1.JNS121626. Epub 2013 Feb 8. — View Citation

Wolff A, Santiago GF, Belzberg M, Huggins C, Lim M, Weingart J, Anderson W, Coon A, Huang J, Brem H, Gordon C. Adult Cranioplasty Reconstruction With Customized Cranial Implants: Preferred Technique, Timing, and Biomaterials. J Craniofac Surg. 2018 Jun;29(4):887-894. doi: 10.1097/SCS.0000000000004385. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the surgical and post-operative outcomes (complications) of two standard of care cohorts: autograft versus allograft (ClearFit)	Asses for infection, hematomas, fractures, mobilization and scar retraction, wound site infection, UTI, pneumonia, delayed internal bleeding, reoperation, and hardware failure	intraoperatively
Primary	To compare the surgical and post-operative outcomes (complications) of two standard of care cohorts: autograft versus allograft (ClearFit)	Asses for infection, hematomas, fractures, mobilization and scar retraction, wound site infection, UTI, pneumonia, delayed internal bleeding, reoperation, and hardware failure	post-operatively through study completion, an average of 1 year
Primary	To compare the surgical and post-operative outcomes (complications) of two standard of care cohorts: autograft versus allograft (ClearFit)	Asses for infection, hematomas, fractures, mobilization and scar retraction, wound site infection, UTI, pneumonia, delayed internal bleeding, reoperation, and hardware failure	2 weeks post-operation
Primary	To compare the surgical and post-operative outcomes (complications) of two standard of care cohorts: autograft versus allograft (ClearFit)	Asses for infection, hematomas, fractures, mobilization and scar retraction, wound site infection, UTI, pneumonia, delayed internal bleeding, reoperation, and hardware failure	6 weeks post-operation
Primary	To compare the surgical and post-operative outcomes (complications) of two standard of care cohorts: autograft versus allograft (ClearFit)	Asses for infection, hematomas, fractures, mobilization and scar retraction, wound site infection, UTI, pneumonia, delayed internal bleeding, reoperation, and hardware failure	3 months post-operation
Primary	To compare the surgical and post-operative outcomes (complications) of two standard of care cohorts: autograft versus allograft (ClearFit)	Asses for infection, hematomas, fractures, mobilization and scar retraction, wound site infection, UTI, pneumonia, delayed internal bleeding, reoperation, and hardware failure	6 months post-operation
Primary	To compare the surgical and post-operative outcomes (complications) of two standard of care cohorts: autograft versus allograft (ClearFit)	Asses for infection, hematomas, fractures, mobilization and scar retraction, wound site infection, UTI, pneumonia, delayed internal bleeding, reoperation, and hardware failure	1 year post-operation
Primary	To assess change in surgical and post-operative outcomes (function) of two standard of care cohorts: autograft versus allograft (ClearFit)	Barthel index consisting of 10 questions - score range 0 (completely dependent)- 20 (completely independent)	24 hours post operation, 2 weeks, 6 weeks, 3 months, 6 months, 1-year
Primary	To assess change in surgical and post-operative outcomes (function) of two standard of care cohorts: autograft versus allograft (ClearFit)	Karnofsky scale (0-100); 0 indicating death and 100 indicating no additional help is needed	24 hours post operation, 2 weeks, 6 weeks, 3 months, 6 months, 1-year
Primary	To assess change the surgical and post-operative outcomes (function) of two standard of care cohorts: autograft versus allograft (ClearFit)	Glasgow Outcome Scale (GOS) on a scale of 1(death)- 5 (good recovery)	24 hours post operation, 2 weeks, 6 weeks, 3 months, 6 months, 1-year
Secondary	To assess change in pain using the Visual Analogue Scale (VAS) Pain scale	Assess change in pain; ranking pain on a scale of 1 (least amount of pain)-10 (greatest amount of pain)	24 hours post operation, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
Secondary	To assess change in disability using the Oswestry Disability Index (ODI)	Assess change in disability; 6 item questionnaire; scores range from 0(minimal d disability)-60 (bed bound)	2 weeks, 6 weeks, 3 months, 6 months, and 1 year
Secondary	To assess change in quality of life using the Health and Quality of life improvement (SF-36)	Assess change in quality of life; 36-item questionnaire, 0 (favorable health state life)-100 (poor health state)	2 weeks, 6 weeks, 3 months, 6 months, and 1 year
Secondary	To assess overall patient satisfaction of two standard of care cohorts: autograft versus allograft (ClearFit)Patient Satisfaction	Patient Satisfaction questionnaire; 5 questions; scores range from 0(unsatisfied) - 22(completely satisfied)	at the 2 week visit