One Year Outcomes From a Prospective Multicenter Investigation Device Trial of a Novel Conformal Mesh Interbody Fusion Device.
Journal
Spine
ISSN: 1528-1159
Titre abrégé: Spine (Phila Pa 1976)
Pays: United States
ID NLM: 7610646
Informations de publication
Date de publication:
15 Jan 2021
15 Jan 2021
Historique:
pubmed:
30
9
2020
medline:
20
4
2021
entrez:
29
9
2020
Statut:
ppublish
Résumé
A prospective multicenter investigational device exempt trial is underway evaluating a novel conformable mesh interbody fusion device in subjects undergoing single-level fusion for degenerative disc disease. Patients meeting inclusion and exclusion criteria were offered enrollment. There is no comparative group in this study. Establish the short and long-term safety and effectiveness of a novel conformable mesh interbody fusion device in subjects undergoing single-level fusion for degenerative disc disease unresponsive to conservative care. Transforaminal lumbar interbody fusion remains a critical procedure for patients with degenerative lumbar disc disease. Increasingly minimally invasive techniques have been proposed to minimize muscle dissection and tissue damage with the goal of minimizing pain and length of stay. One hundred two subjects were enrolled across 10 sites. Ninety nine subjects remained available for follow-up at 12-months. Physical evaluations/imaging were performed serially through 12-months. Validated assessment tools included 100 mm visual analogue scale (VAS) for pain, Oswestry Disability Index (ODI) for function, and computerized tomography scan for fusion. Independent committees were used to identify adverse events and for assessment of radiographic fusion. Reductions in low back pain (LBP)/leg pain and improvements in functional status occur early and are maintained through 12-month follow-up. Mean VAS-LBP change from baseline to 6-weeks post-op (-46 mm) continued to improve through 12 months (-51 mm). Similar trends were observed for leg pain. Mean ODI change from baseline to 6 weeks post-op (-17) was almost doubled by 12 months (-32). Fusion rates at 12-months are high (98%). No device-related serious adverse events have occurred. 12-month outcomes demonstrated excellent patient compliance and positive outcomes for pain, function, fusion, and device safety. Clinical improvements were observed by 6-weeks post-op and appear durable up to 1 year later. A novel mesh interbody device may provide an alternative means of interbody fusion that reduces connective tissue disruption.Level of Evidence: 3.
Sections du résumé
STUDY DESIGN
METHODS
A prospective multicenter investigational device exempt trial is underway evaluating a novel conformable mesh interbody fusion device in subjects undergoing single-level fusion for degenerative disc disease. Patients meeting inclusion and exclusion criteria were offered enrollment. There is no comparative group in this study.
OBJECTIVE
OBJECTIVE
Establish the short and long-term safety and effectiveness of a novel conformable mesh interbody fusion device in subjects undergoing single-level fusion for degenerative disc disease unresponsive to conservative care.
SUMMARY OF BACKGROUND DATA
BACKGROUND
Transforaminal lumbar interbody fusion remains a critical procedure for patients with degenerative lumbar disc disease. Increasingly minimally invasive techniques have been proposed to minimize muscle dissection and tissue damage with the goal of minimizing pain and length of stay.
METHODS
METHODS
One hundred two subjects were enrolled across 10 sites. Ninety nine subjects remained available for follow-up at 12-months. Physical evaluations/imaging were performed serially through 12-months. Validated assessment tools included 100 mm visual analogue scale (VAS) for pain, Oswestry Disability Index (ODI) for function, and computerized tomography scan for fusion. Independent committees were used to identify adverse events and for assessment of radiographic fusion.
RESULTS
RESULTS
Reductions in low back pain (LBP)/leg pain and improvements in functional status occur early and are maintained through 12-month follow-up. Mean VAS-LBP change from baseline to 6-weeks post-op (-46 mm) continued to improve through 12 months (-51 mm). Similar trends were observed for leg pain. Mean ODI change from baseline to 6 weeks post-op (-17) was almost doubled by 12 months (-32). Fusion rates at 12-months are high (98%). No device-related serious adverse events have occurred.
CONCLUSION
CONCLUSIONS
12-month outcomes demonstrated excellent patient compliance and positive outcomes for pain, function, fusion, and device safety. Clinical improvements were observed by 6-weeks post-op and appear durable up to 1 year later. A novel mesh interbody device may provide an alternative means of interbody fusion that reduces connective tissue disruption.Level of Evidence: 3.
Identifiants
pubmed: 32991515
pii: 00007632-202101150-00018
doi: 10.1097/BRS.0000000000003710
doi:
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
E126-E132Informations de copyright
Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.
Références
Jin-Tao Q, Yu T, Mei W, et al. Comparison of MIS vs. open PLIF/TLIF with regard to clinical improvement, fusion rate, and incidence of major complication: a meta-analysis. Eur Spine J 2015; 24:1058–1065.
Bevevino AJ, Kang DG, Lehman RA, et al. Systematic review and meta-analysis of minimally invasive transforaminal lumbar interbody fusion rates performed without posterolateral fusion. J Clin Neurosci 2014; 21:1686–1690.
Ruan W, Feng F, Liu Z, Xie J, Cai L, Ping A. Comparison of percutaneous endoscopic lumbar discectomy versus open lumbar microdiscectomy for lumbar disc herniation: a meta-analysis. Int J Surg 2016; 31:86–92.
Rasouli MR, Rahimi-Movaghar V, Shokraneh F, Moradi-Lakeh M, Chou R. Minimally invasive discectomy versus microdiscectomy/open discectomy for symptomatic lumbar disc herniation. Cochrane Database Syst Rev 2014; (9):CD010328.
Arts MP, Brand R, van den Akker ME, et al. Tubular diskectomy vs conventional microdiskectomy for sciatica: a randomized controlled trial. JAMA 2009; 302:149–158.
Arts MP, Brand R, van den Akker ME, et al. Tubular diskectomy vs conventional microdiskectomy for the treatment of lumbar disk herniation: 2-year results of a double-blind randomized controlled trial. Neurosurgery 2011; 69:135–144. discussion 144.
Wang MY, Grossman J. Endoscopic minimally invasive transforaminal interbody fusion without general anesthesia: initial clinical experience with 1-year follow-up. Neurosurg Focus 2016; 40:E13.
Wang MY, Chang HK, Grossman J. Reduced acute care costs with the eras(r) minimally invasive transforaminal lumbar interbody fusion compared with conventional minimally invasive transforaminal lumbar interbody fusion. Neurosurgery 2018; 83:827–834.
Odom GL, Finney W, Woodhall B. Cervical disk lesions. J Am Med Assoc 1958; 166:23–28.
Kambin P, Sampson S. Posterolateral percutaneous suction-excision of herniated lumbar intervertebral discs. Report of interim results. Clin Orthop Relat Res 1986; 37–43.
Hardenbrook M, Lombardo S, Wilson MC, Telfeian AE. The anatomic rationale for transforaminal endoscopic interbody fusion: a cadaveric analysis. Neurosurg Focus 2016; 40:E12.
Pearson AM, Lurie JD, Tosteson TD, Zhao W, Abdu WA, Weinstein JN. Who should undergo surgery for degenerative spondylolisthesis? Treatment effect predictors in SPORT. Spine (Phila Pa 1976) 2013; 38:1799–1811.
Carreon LY, Glassman SD, Howard J. Fusion and nonsurgical treatment for symptomatic lumbar degenerative disease: a systematic review of Oswestry Disability Index and MOS Short Form-36 outcomes. Spine J 2008; 8:747–755.
Bourghli A, Aunoble S, Reebye O, Le Huec JC. Correlation of clinical outcome and spinopelvic sagittal alignment after surgical treatment of low-grade isthmic spondylolisthesis. Eur Spine J 2011; 20: (suppl): 663–668.
Chapman JR, Norvell DC, Hermsmeyer JT, et al. Evaluating common outcomes for measuring treatment success for chronic low back pain. Spine (Phila Pa 1976) 2011; 36: (21 suppl): S54–S68.
Terman SW, Yee TJ, Lau D, Khan AA, La Marca F, Park P. Minimally invasive versus open transforaminal lumbar interbody fusion: comparison of clinical outcomes among obese patients. J Neurosurg Spine 2014; 20:644–652.
Phan K, Rao PJ, Kam AC, Mobbs RJ. Minimally invasive versus open transforaminal lumbar interbody fusion for treatment of degenerative lumbar disease: systematic review and meta-analysis. Eur Spine J 2015; 24:1017–1030.
Wang MY, Lerner J, Lesko J, McGirt MJ. Acute hospital costs after minimally invasive versus open lumbar interbody fusion: data from a US national database with 6106 patients. J Spinal Disord Tech 2012; 25:324–328.
Isaacs RE, Sembrano JN, Tohmeh AG. SOLAS Degenerative Study Group. Two-year comparative outcomes of MIS lateral and MIS transforaminal interbody fusion in the treatment of degenerative spondylolisthesis: Part II: radiographic findings. Spine (Phila Pa 1976) 2016; 41: (suppl): S133–S144.
Sembrano JN, Tohmeh A, Isaacs R. SOLAS Degenerative Study Group. Two-year comparative outcomes of MIS Lateral and MIS Transforaminal interbody fusion in the treatment of degenerative spondylolisthesis: Part I: clinical findings. Spine (Phila Pa 1976) 2016; 41: (suppl): S123–S132.
Landham PR, Don AS, Robertson PA. Do position and size matter? An analysis of cage and placement variables for optimum lordosis in PLIF reconstruction. Eur Spine J 2017; 26:2843–2850.
Cannestra AF, Peterson MD, Parker SR, Roush TF, Bundy JV, Turner AW. MIS expandable interbody spacers: a literature review and biomechanical comparison of an expandable MIS TLIF with conventional TLIF and ALIF. Spine (Phila Pa 1976) 2016; 41: (suppl): S44–S49.
Gonzalez-Blohm SA, Doulgeris JJ, Aghayev K, Lee WE, Laun J, Vrionis FD. In vitro evaluation of a lateral expandable cage and its comparison with a static device for lumbar interbody fusion: a biomechanical investigation. J Neurosurg Spine 2014; 20:387–395.
Zheng X, Chaudhari R, Wu C, Mehbod AA, Erkan S, Transfeldt EE. Biomechanical evaluation of an expandable meshed bag augmented with pedicle or facet screws for percutaneous lumbar interbody fusion. Spine J 2010; 10:987–993.