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EARLY ASSESSMENT AND PREDICTION OF POTENTIAL IMPACT OF THE IMPLANTATION OF POLYURETHANE SCAFFOLD IN PARTIAL MENISCAL LESIONS: A PILOT HORIZON SCANNING ACTIVITY IN SOUTH KOREA

Published online by Cambridge University Press:  18 December 2015

Ji Yun Tark
Affiliation:
Department of Horizon Scanning for Innovative Global Health Technology, National Evidence-Based Healthcare Collaborating Agency (NECA)
Ji-young Jeong
Affiliation:
Division for New Health Technology Assessment, National Evidence-Based Healthcare Collaborating Agency (NECA)
Min Lee
Affiliation:
Division for New Health Technology Assessment, National Evidence-Based Healthcare Collaborating Agency (NECA)
Eunjung Park
Affiliation:
Department of Horizon Scanning for Innovative Global Health Technology, National Evidence-Based Healthcare Collaborating Agency (NECA)
Jooyeon Park
Affiliation:
Department of Horizon Scanning for Innovative Global Health Technology, National Evidence-Based Healthcare Collaborating Agency (NECA)
Ji Jeong Park
Affiliation:
Department of Horizon Scanning for Innovative Global Health Technology, National Evidence-Based Healthcare Collaborating Agency (NECA)
Sungkyu Lee
Affiliation:
Department of Horizon Scanning for Innovative Global Health Technology, National Evidence-Based Healthcare Collaborating Agency (NECA)
Chaemin Shin
Affiliation:
Department of Horizon Scanning for Innovative Global Health Technology, National Evidence-Based Healthcare Collaborating Agency (NECA) [email protected]

Abstract

Objectives: The aim of this study was to predict the potential impact of the introduction of implantation of polyurethane scaffold for the treatment of partial meniscal lesions in the South Korean healthcare system.

Methods: The horizon scanning process was used to select a target technology and assess its potential impacts on patients and the Korean healthcare system. We identified and filtered research-phase health technologies that are not listed yet in Korean, but appear promising. After a process of prioritization, we chose the implantation of polyurethane scaffolds as a target technology. Then, through the procedures of assessment and peer review, we analyzed current evidence and its predicted potential impacts.

Results: There were eight studies included in the review: one prospective cohort and seven case-series studies. Six revealed significant improvements in function and pain relief. Of the six studies, which reported safety endpoints, four stated no major postoperative complications related to scaffold, and two reported adverse events and serious adverse events such as pain, joint swelling, et cetera. We also included the potential impact of this technology based on the experts’ consultation. They all agreed that it would satisfy the diverse needs of patients and fulfill clinical needs. However, the majority of related clinical studies were based on short-term follow-up observations without any validation process involving comparison with control groups.

Conclusions: Through a horizon scanning activity, we found that the implantation of polyurethane scaffolds is a promising technology to resolve articular cartilage defects; however, long-term evidence with comparison groups for safety and effectiveness is required.

Type
Assessments
Copyright
Copyright © Cambridge University Press 2015 

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References

REFERENCES

1. Gutierrez-Ibarluzea, I, Simpson, S, Benguria-Arrate, G, Members of EuroScan International Network. Early awareness and alert systems: An overview of EuroScan methods. Int J Technol Assess Health Care. 2012;28:301307.Google Scholar
2. Peter, K. Horizon scanning for evidence-based decisions by governments – Systematic Review. The ULYSSES program. 3rd Edition 2005–2007. http://www.health-evaluation.ch/fileadmin/user_upload/pdf-Dokumente/health-evaluation/berichte/HorizonScanningMasterThesis.pdf (accessed June 30, 2014).Google Scholar
3. Website of EuroScan International Network. http://euroscan.org.uk/about/ (accessed June 30, 2014).Google Scholar
4. Cook, JL, Tomlinson, JL, Kreeger, JM, Cook, CR. Induction of meniscal regeneration in dogs using a novel biomaterial. Am J Sports Med. 1999;27:658665.Google Scholar
5. Kim, TH, Oh, SH, Lee, MC, Lee, JH. Fabrication and analysis of a polymeric scaffold in a meniscus shape introduced with two types of growth factors. Biomater Res. 2010;14:131139.Google Scholar
6. Health Insurance Review & Assessment Service, Medical Care Institution Service Portal Site. 2014. http://www.hira.or.kr/main.do (accessed June 30, 2014).Google Scholar
7. Choi, JH, Choi, YJ. Results of the meniscal allograft transplantation. J Korean Arthrosc Soc. 2011;15:3641.Google Scholar
8. Lubowitz, J, Verdonk, P, Reid, J, Verdonk, R. Meniscus allograft transportation: A current concepts review. Knee Surg Sports Traumatol Arthrosc. 2007;15:476492.CrossRefGoogle Scholar
9. Stollsteimer, GT, Shelton, WR, Dukes, A, Bomboy, AL. Meniscal allograft transplantation: A 1- to 5-year follow-up of 22 patients. Arthroscopy. 2000;16:343347.Google Scholar
10. Choi, NH, Oh, JS. Treatment of meniscal lesions: Meniscectomy, repair and allograft transplantation. J Korean Orthop Assoc. 2012;47:165170.CrossRefGoogle Scholar
11. Myers, KR, Sgaglione, NA, Kurzweil, PR. A current update on meniscal scaffolds. Oper Techn Sport Med. 2013;21:7581.CrossRefGoogle Scholar
12. United Healthcare Oxford. Meniscus implant and allograft (Clinical Policy#: SURGERY 096.6.T2; Nov2013). https://www.oxhp.com/secure/policy/meniscus_implant_and_allograft.pdf (accessed June 30, 2014).Google Scholar
13. Results of the 10th Assessment by the Committee for New Health Technology Assessment (Accessed with special permission on May 20, 2014).Google Scholar
14. Website of ACTIFIT. http://actifit.info/ (accessed June 30, 2014).Google Scholar
15. Verdonk, R. Polyurethane implant (AACTIFIT). In: Meniscal transplantation. Berlin, Heidelberg: Springer; 2013:8397.Google Scholar
16. Website of Center for New Health Technology Assessment. http://nhta.or.kr/nHTA/eng/ (accessed June 30, 2014).Google Scholar
17. Kon, E, Filardo, G, Zaffagnini, S, et al. Biodegradable polyurethane meniscal scaffold for isolated partial lesions or as combined procedure for knees with multiple comorbidities: Clinical results at 2 years. Knee Surg Sports Traumatol Arthrosc. 2014;22:128134.Google Scholar
18. Bouyarmane, H, Beaufils, P, Pujol, N, et al. Polyurethane scaffold in lateral meniscus segmental defects: Clinical outcomes at 24 months follow-up. Orthop Traumatol Surg Res. 2014;100:153157.Google Scholar
19. Efe, T, Getgood, A, Schofer, MD, et al. The safety and short-term efficacy of a novel polyurethane meniscal scaffold for the treatment of segmental medial meniscus deficiency. Knee Surg Sports Traumatol Arthrosc. 2012;20:18221830.CrossRefGoogle ScholarPubMed
20. Bulgheroni, P, Bulgheroni, E, Regazzola, G, Mazzola, C. Polyurethane scaffold for the treatment of partial meniscal tears. Clinical results with a minimum two-year follow-up. Joints. 2013;1:161166.Google Scholar
21. Verdonk, P, Beaufils, P, Bellemans, J, et al. Successful treatment of painful irreparable partial meniscal defects with a polyurethane scaffold: Two-year safety and clinical outcomes. Am J Sports Med. 2012;40:844853.Google Scholar
22. Verdonk, R, Verdonk, P, Huysse, W, Forsyth, R, Heinrichs, EL. Tissue ingrowth after implantation of a novel, biodegradable polyurethane scaffold for treatment of partial meniscal lesions. Am J Sports Med. 2011;39:774782.Google Scholar
23. Spencer, SJ, Saithna, A, Carmont, MR, et al. Meniscal scaffolds: Early experience and review of the literature. Knee. 2012;19:760765.Google Scholar
24. Coninck, T, Huysse, W, Willemot, L, et al. Two-year follow-up study on clinical and radiological outcomes of polyurethane meniscal scaffolds. Am J Sports Med. 2013;41:6472.Google Scholar
25. Scotti, A, Hirschmann, MT, Antinolfi, P, Martin, I, Peretti, GM. Meniscus repair and regeneration: Review on current methods and research potential. Eur Cell Mater. 2013;26:150170.Google Scholar
26. National Institute for Health and Clinical Excellence. Interventional procedure guidance 430: Partial replacement of the meniscus of the knee using a biodegradable scaffold. London: NICE; 2012.Google Scholar