The Results of Lomber Disc Hernia Patients Treated with Disc Restoration Hydrogel Implant (Gelstixtm): A Retrospective Cohort Study
Öz
Objective: This study aims to evaluate the results of disc restoration hydrogel implanted (GelstixTM) lumber disc hernia patients.
Materials and Method: Patients suffering from chronic back pain diagnosed with lumber disc hernia who were admitted to Firat University Algology Clinic and treated with disc restoration hydrogel between January 2013 and January 2014 were evaluated. Cases were evaluated for demographic characteristics, magnetic resistance imaging findings, preoperative and postoperative visual analog scale (VAS) scores, complications, side effects, and patient satisfaction after the procedure.
Results: Of the operated 62 patients were 25 male (40.3%) and 37 female (59.7%). The mean age of all patients was 49.18±14.18 years, the mean age of female patients was 50.81±13.37 years and the mean age of male patients was 46.76±15.27 years. The mean duration of pain in female and male patients was 37.81±37.92 months and 25.36±33.58 months, respectively. Preoperative and postoperative VAS scores of female patients were 8.24±1.09 and 3.56±2.11; male patients were 7.88±1.01 and 3.76±2.17, respectively. Of the 62 patients suffered from 16 right leg pain (25.8%), 20 left leg pain (32. 3%), and 26 bilateral lower limb pain (41.9%). Of 62 patients 31 had no additional disorders (50%), 12 had cardiac disorders (19.4%), 3 had (4.8%) respiratory disorders, 7 had endocrine disorders (11.3%), 4 had both endocrine and cardiac disorders (6.5%), 2 had both cardiac and respiratory disorders (3.2%), 1 had both endocrine and respiratory disorders (1.6%), and 2 had both endocrine, cardiac and respiratory disorders (3.2%). Of the 62 patients 25 had bulging (40.3%), 5 had protrusion (8.1%), 4 had narrowed neural foramen (6.5%), 18 had bulging+narrowed neural foramen (29%), 3 had narrowed neural foramen + protrusion (4.8%) and 7 had bulging + protrusion (11.3%). Thirteen patients hadn’t had previous therapy (20.97%), transforaminal steroid injection was applied to 29 patients (46.77%), and medical therapy (such as NSAID, miyorelactants) was applied to 20 (32.26%). Levels of complaints were 2 at L2-L3 (3. 2%), 17 at L3-L4 (27.4%), 28 at L4-L5 (45.2%), and 15 at L5-S1 (24.2%). Without L2-L3 level other operated levels had significant differences between preoperative VAS scores and postoperative VAS scores. The number of unsatisfied patients was 9 (14.5%), moderated satisfied patients number 16(25.8%), good satisfied patients number was 16 (25. 8%), and perfectly satisfied patients number was 21 (33.9%).
Conclusion: Disc restoration hydrogel is a safe minimal invasive technique with satisfactory results, low complication rates, and low side effect risk especially in young and middle-aged patients.
Anahtar Kelimeler
Back Pain Lomber Disc Hernia Intervertebral Disc Disc Restoration Hydrogel Implant
Kaynakça
- Will JS, Bury DC, Miller JA. Mechanical Low Back Pain. Am Fam Physician. 2018;98(7):421–8.
- Tavee JO, Levin KH. Low Back Pain. Contin Lifelong Learn Neurol. 2017;23(2):467–86. Jordan J, Konstantinou K, O’Dowd J. Herniated lumbar disc. BMJ Clin Evid [Internet]. 2011;2011:1118.
- Frymoyer JW. Back Pain and Sciatica. N Engl J Med. 1988;318(5):291–300.
- Legrand E, Bouvard B, Audran M, Fournier D, Valat JP. Sciatica from disk herniation: Medical treatment or surgery? Jt Bone Spine. 2007;74(6):530–5.
- Luijsterburg PAJ, Verhagen AP, Ostelo RWJG, van Os TAG, Peul WC, Koes BW. Effectiveness of conservative treatments for the lumbosacral radicular syndrome: a systematic review. Eur Spine J. 2007;16(7):881–99.
- Kawaguchi Y, Matsui H, Gejo R, Tsuji H. Preventive Measures of Back Muscle Injury After Posterior Lumbar Spine Surgery in Rats. Spine (Phila Pa 1976). 1998;23(21):2282–7.
- Zhu H, Wang G, Zhou Z, Fan S. Prospective Study of Long-term Effect between Multifidus Muscle Bundle and Conventional Open Approach in One-level Posterior Lumbar Interbody Fusion. Orthop Surg. 2018;10(4):296–305.
- Weber BR, Grob D, Dvorák J, Müntener M. Posterior Surgical Approach to the Lumbar Spine and Its Effect on the Multifidus Muscle. Spine (Phila Pa 1976). 1997;22(15):1765–72.
- Bresnahan LE, Smith JS, Ogden AT, Quinn S, Cybulski GR, Simonian N, et al. Assessment of Paraspinal Muscle Cross-sectional Area After Lumbar Decompression. Clin Spine Surg. 2017;30(3):E162–8.
- Malhotra NR, Han WM, Beckstein J, Cloyd J, Chen W, Elliott DM. An Injectable Nucleus Pulposus Implant Restores Compressive Range of Motion in the Ovine Disc. Spine (Phila Pa 1976). 2012;37(18):E1099–105.
- Gorapalli D, Seth A, Vournakis J, Whyne C, Akens M, Zhang A, et al. Evaluation of a novel poly N-acetyl glucosamine (pGlcNAc) hydrogel for treatment of the degenerating intervertebral disc. Life Sci. 2012;91(25–26):1328–35.
- Benz K, Stippich C, Fischer L, Möhl K, Weber K, Lang J, et al. Intervertebral disc cell- and hydrogel-supported and spontaneous intervertebral disc repair in nucleotomized sheep. Eur Spine J. 2012;21(9):1758–68.
- Benz K, Stippich C, Osswald C, Gaissmaier C, Lembert N, Badke A, et al. Rheological and biological properties of a hydrogel support for cells intended for intervertebral disc repair. BMC Musculoskelet Disord. 2012;13(1):54.
- Kranenburg H-JC, Meij BP, Onis D, van der Veen AJ, Saralidze K, Smolders LA, et al. Design, synthesis, imaging, and biomechanics of a softness-gradient hydrogel nucleus pulposus prosthesis in a canine lumbar spine model. J Biomed Mater Res Part B Appl Biomater. 2012;100B(8):2148–55.
- Shamie A, Yazdanshenas H. Effectiveness of titanium plate usage in laminoplasty. J Craniovertebr Junction Spine. 2019;10(1):14–8.
- Oliphant D. Safety of Spinal Manipulation in the Treatment of Lumbar Disk Herniations: A Systematic Review and Risk Assessment. J Manipulative Physiol Ther. 2004;27(3):197–210.
- Cloyd JM, Malhotra NR, Weng L, Chen W, Mauck RL, Elliott DM. Material properties in unconfined compression of human nucleus pulposus, injectable hyaluronic acid-based hydrogels and tissue engineering scaffolds. Eur Spine J. 2007;16(11):1892–8.
- Boyd LM, Carter AJ. Injectable biomaterials and vertebral endplate treatment for repair and regeneration of the intervertebral disc. Eur Spine J. 2006;15:414–21.
- Sarı S, Aydoğan M. Bel ağrısının önemli bir sebebi: lomber disk hernisi. TOTBID Derg. 2015;14(4):298–304.
- Hermenau S, Prewet A, Ramachandran R. The Biochemistry of Spinal Implants: Short- and Long Term Considerations. In: Yue J., Guyer R., Johnson J., Khoo L, editors. The Comprehensive Treatment of the Aging Spine. Elsevier; 2010. p. 459–65.
- Jian Y, Le X, Zhang Y, Lu W, Wang L, Zheng J, et al. Shape Memory Hydrogels with Simultaneously Switchable Fluorescence Behavior. Macromol Rapid Commun. 2018;39(12):e1800130.
- Liang R, Yu H, Wang L, Lin L, Wang N, Naveed K-R. Highly Tough Hydrogels with the Body Temperature-Responsive Shape Memory Effect. ACS Appl Mater Interfaces. 2019;11(46):43563–72.
- Zhu H, Zhou X-Z, Cheng M-H, Shen Y-X, Dong Q-R. The efficacy of coblation nucleoplasty for protrusion of lumbar intervertebral disc at a two-year follow-up. Int Orthop. 2011;35(11):1677–82.
- Weiner BK, Fraser RD. Foraminal Injection for Lateral Lumbar Disc Herniation. J Bone Jt Surg. 1997;79(5):804–7.
- Gullbrand SE, Schaer TP, Agarwal P, Bendigo JR, Dodge GR, Chen W, et al. Translation of an injectable triple-interpenetrating-network hydrogel for intervertebral disc regeneration in a goat model. Acta Biomater. 2017;60:201–9.
- Hirase T, Jack II RA, Sochacki KR, Harris JD, Weiner BK. Systemic Review: Is an Intradiscal Injection of Platelet-Rich Plasma for Lumbar Disc Degeneration Effective? Cureus. 2020;12(6):e8831.
Disk Restorasyon Hidrojel İmplantı (Gelstixtm) ile Tedavi Edilen Lomber Disk Hernisi Hastalarının Sonuçları: Retrospektif Bir Kohort Çalışması
Öz
Giriş: Lomber disk hernisi hastalarında disk restorasyon hidrojel implant (GelstixTM) uygulanmasının kliniğimizdeki sonuçlarını değerlendirmek amaçlanmıştır.
Gereç ve Yöntemler: Fırat Üniversitesi Hastanesi Algoloji Polikliniği’ne başvuran lomber disk hernisi tanısı almış,kronik diskojenik ağrılı, Ocak 2013–Ocak 2014 tarihleri arasında bir yıllık sürede disk restorasyon hidrojel uygulanan hastalar retrospektif olarak değerlendirildi. Olgular demografik karakteristikleri,magnetik rezonans görüntüleme bulguları, preoperatif ve postoperatif vizüel analog skala (VAS) skorları, komplikasyonlar, yan etkiler ve işlem sonrası hasta memnuniyeti açısından incelendi.
Bulgular: Yirmi beşi erkek (%40,3), 37'si kadın (%59,7) toplam 62 hastaya işlem yapıldı. Hastaların yaş ortalaması 49,18 ± 14,18 yıl,kadın hastaların yaşları 50,81±13,37 yıl ve erkek hastaların yaşları 46,76±15,27 yıldı. Kadın ve erkek hastaların ağrı süreleri sırasıyla 37,81±37,92 ay ve 25,36±33,58 aydı. Preoperatif ve postoperatif VAS skorları kadın hastalarda 8,24±1,09 ve 3,56±2,11; erkek hastalarda 7,88±1,01 ve 3,76±2,17 idi. Onaltı (% 25,8) sağ bacak ağrısı, 20(%32,3) sol bacak ağrısı, 26(%41,9) bilateral alt ekstremite ağrısıyla kliniğimize başvurdu. Hastaların 31’inde (%50) ek bir hastalık olmadığı, 12’sinde (%19,4) kardiak hastalık, 3’ünde (%4,8) respiratuar hastalık, 7’sinde (%11,3) endokrin hastalık, 4’ünde (%6,5) endokrin ve kardiyak hastalık beraber, 2’sinde (%3,2) kardiyak ve respiratuar hastalık beraber, 1’inde (%1,6) endokrin ve respiratuar hastalığın beraber ve 2’sinde (%3,2) endokrin, kardiyak ve respiratuar ek hastalığının beraber olduğu görüldü. Hastaların 25’inde bulging (%40,3), 5’inde protrüzyon (%8,1), 4’ünde NFD (%6,5), 18’inde bulging + NFD (%29), 3’ünde NFD + protrüzyon(%4,8) ve 7’sinde bulging + protrüzyon (%11,3) vardı. Onüç hastanın (%20,97) daha önce tedavi almadığı, 29’unun (%46,77) transforaminal steroid tedavisi aldığı ve 20’sinin(%32,26) sadece medikal tedavi aldığı tespit edildi. Şikayet seviyesi 2 hastada L2-L3 (%3,2), 17’sinde L3-L4 (%27,4), 28’inde L4-L5 (%45,2) ve 15’inde L5-S1’di (%24,2). Memnun olmayan hasta sayısı 9(%14,5), orta derecede memnun kalan hasta sayısı 16(%25,8), iyi derecede memnun olan hasta sayısı 16 (%25,8), mükemmel derecede memnun olan hasta sayısı ise 21’di (%33,9).
Sonuç: Disk restorasyon hidrojel özellikle genç ve orta yaş hastalarda diskojenik ağrıya karşı tatmin edici sonuçlarla kullanılabilen, düşük komplikasyon ve yan etki riskine sahip güvenli bir minimal invazif tekniktir.
Anahtar Kelimeler
Bel ağrısı Lumber Disk Hernisi İntervertebral Disk Disk Restorasyon Hidrojel İmplant
Kaynakça
- Will JS, Bury DC, Miller JA. Mechanical Low Back Pain. Am Fam Physician. 2018;98(7):421–8.
- Tavee JO, Levin KH. Low Back Pain. Contin Lifelong Learn Neurol. 2017;23(2):467–86. Jordan J, Konstantinou K, O’Dowd J. Herniated lumbar disc. BMJ Clin Evid [Internet]. 2011;2011:1118.
- Frymoyer JW. Back Pain and Sciatica. N Engl J Med. 1988;318(5):291–300.
- Legrand E, Bouvard B, Audran M, Fournier D, Valat JP. Sciatica from disk herniation: Medical treatment or surgery? Jt Bone Spine. 2007;74(6):530–5.
- Luijsterburg PAJ, Verhagen AP, Ostelo RWJG, van Os TAG, Peul WC, Koes BW. Effectiveness of conservative treatments for the lumbosacral radicular syndrome: a systematic review. Eur Spine J. 2007;16(7):881–99.
- Kawaguchi Y, Matsui H, Gejo R, Tsuji H. Preventive Measures of Back Muscle Injury After Posterior Lumbar Spine Surgery in Rats. Spine (Phila Pa 1976). 1998;23(21):2282–7.
- Zhu H, Wang G, Zhou Z, Fan S. Prospective Study of Long-term Effect between Multifidus Muscle Bundle and Conventional Open Approach in One-level Posterior Lumbar Interbody Fusion. Orthop Surg. 2018;10(4):296–305.
- Weber BR, Grob D, Dvorák J, Müntener M. Posterior Surgical Approach to the Lumbar Spine and Its Effect on the Multifidus Muscle. Spine (Phila Pa 1976). 1997;22(15):1765–72.
- Bresnahan LE, Smith JS, Ogden AT, Quinn S, Cybulski GR, Simonian N, et al. Assessment of Paraspinal Muscle Cross-sectional Area After Lumbar Decompression. Clin Spine Surg. 2017;30(3):E162–8.
- Malhotra NR, Han WM, Beckstein J, Cloyd J, Chen W, Elliott DM. An Injectable Nucleus Pulposus Implant Restores Compressive Range of Motion in the Ovine Disc. Spine (Phila Pa 1976). 2012;37(18):E1099–105.
- Gorapalli D, Seth A, Vournakis J, Whyne C, Akens M, Zhang A, et al. Evaluation of a novel poly N-acetyl glucosamine (pGlcNAc) hydrogel for treatment of the degenerating intervertebral disc. Life Sci. 2012;91(25–26):1328–35.
- Benz K, Stippich C, Fischer L, Möhl K, Weber K, Lang J, et al. Intervertebral disc cell- and hydrogel-supported and spontaneous intervertebral disc repair in nucleotomized sheep. Eur Spine J. 2012;21(9):1758–68.
- Benz K, Stippich C, Osswald C, Gaissmaier C, Lembert N, Badke A, et al. Rheological and biological properties of a hydrogel support for cells intended for intervertebral disc repair. BMC Musculoskelet Disord. 2012;13(1):54.
- Kranenburg H-JC, Meij BP, Onis D, van der Veen AJ, Saralidze K, Smolders LA, et al. Design, synthesis, imaging, and biomechanics of a softness-gradient hydrogel nucleus pulposus prosthesis in a canine lumbar spine model. J Biomed Mater Res Part B Appl Biomater. 2012;100B(8):2148–55.
- Shamie A, Yazdanshenas H. Effectiveness of titanium plate usage in laminoplasty. J Craniovertebr Junction Spine. 2019;10(1):14–8.
- Oliphant D. Safety of Spinal Manipulation in the Treatment of Lumbar Disk Herniations: A Systematic Review and Risk Assessment. J Manipulative Physiol Ther. 2004;27(3):197–210.
- Cloyd JM, Malhotra NR, Weng L, Chen W, Mauck RL, Elliott DM. Material properties in unconfined compression of human nucleus pulposus, injectable hyaluronic acid-based hydrogels and tissue engineering scaffolds. Eur Spine J. 2007;16(11):1892–8.
- Boyd LM, Carter AJ. Injectable biomaterials and vertebral endplate treatment for repair and regeneration of the intervertebral disc. Eur Spine J. 2006;15:414–21.
- Sarı S, Aydoğan M. Bel ağrısının önemli bir sebebi: lomber disk hernisi. TOTBID Derg. 2015;14(4):298–304.
- Hermenau S, Prewet A, Ramachandran R. The Biochemistry of Spinal Implants: Short- and Long Term Considerations. In: Yue J., Guyer R., Johnson J., Khoo L, editors. The Comprehensive Treatment of the Aging Spine. Elsevier; 2010. p. 459–65.
- Jian Y, Le X, Zhang Y, Lu W, Wang L, Zheng J, et al. Shape Memory Hydrogels with Simultaneously Switchable Fluorescence Behavior. Macromol Rapid Commun. 2018;39(12):e1800130.
- Liang R, Yu H, Wang L, Lin L, Wang N, Naveed K-R. Highly Tough Hydrogels with the Body Temperature-Responsive Shape Memory Effect. ACS Appl Mater Interfaces. 2019;11(46):43563–72.
- Zhu H, Zhou X-Z, Cheng M-H, Shen Y-X, Dong Q-R. The efficacy of coblation nucleoplasty for protrusion of lumbar intervertebral disc at a two-year follow-up. Int Orthop. 2011;35(11):1677–82.
- Weiner BK, Fraser RD. Foraminal Injection for Lateral Lumbar Disc Herniation. J Bone Jt Surg. 1997;79(5):804–7.
- Gullbrand SE, Schaer TP, Agarwal P, Bendigo JR, Dodge GR, Chen W, et al. Translation of an injectable triple-interpenetrating-network hydrogel for intervertebral disc regeneration in a goat model. Acta Biomater. 2017;60:201–9.
- Hirase T, Jack II RA, Sochacki KR, Harris JD, Weiner BK. Systemic Review: Is an Intradiscal Injection of Platelet-Rich Plasma for Lumbar Disc Degeneration Effective? Cureus. 2020;12(6):e8831.
Ayrıntılar
| Birincil Dil | İngilizce |
|---|---|
| Konular | Sağlık Kurumları Yönetimi |
| Bölüm | Araştırma Makaleleri |
| Yazarlar | |
| Erken Görünüm Tarihi | 28 Mart 2024 |
| Yayımlanma Tarihi | 28 Mart 2024 |
| Gönderilme Tarihi | 16 Eylül 2022 |
| Kabul Tarihi | 7 Ekim 2022 |
| Yayımlandığı Sayı | Yıl 2024 Cilt: 19 Sayı: 1 |
