The Fernstrom ball revisited

Siemionow, Krzysztof; Hu, Xiaobang; Lieberman, Isador H.

doi:10.1007/s00586-011-2040-y

Cited by 13 publications

(4 citation statements)

References 6 publications

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“…Aside from the early experimentation with the Fernstrom ball and the suturing techniques of Yasargil, mechanical nucleus replacement or augmentation devices have been used in Europe for over 20 years and prostheses for anular closure have been used for almost 10 years. [34][35][36][37][38][39][40][41] Preliminary results of most designs involved small series and were not sufficiently safe to warrant larger clinical series, leading to device discontinuation, redesign, or premature commercial launch. 40,41 The overall conclusion from these experiences has been that materials inserted into the disc will migrate, extrude, or subside into the endplates if not firmly anchored to the bone.…”

Section: Discussionmentioning

confidence: 99%

“…40,41 The overall conclusion from these experiences has been that materials inserted into the disc will migrate, extrude, or subside into the endplates if not firmly anchored to the bone. 35,37,38,40,41 The objective of the current trial is to demonstrate that a prosthesis for anular closure can safely and effectively prevent poor outcomes after discectomy, namely, recurrent pain, dysfunction, and same-level herniation, by blocking the anular defect. Building upon lessons learned from previous designs, the current design includes an anchor that secures the occlusion component to an adjacent vertebral body in an effort to minimize migration and subsidence.…”

Section: Discussionmentioning

confidence: 99%

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A multicenter, prospective, randomized study protocol to demonstrate the superiority of a bone-anchored prosthesis for anular closure used in conjunction with limited discectomy to limited discectomy alone for primary lumbar disc herniation

et al. 2016

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Background: Same-level reherniation and progressive degeneration with disc height loss are main causes of poor outcome after discectomy and may necessitate reoperation. A novel prosthesis for anular closure was developed to address these causes.Methods: The design of a multicenter, prospective, randomized, post-market superiority trial comparing limited lumbar discectomy augmented with this device (intervention group) with limited lumbar discectomy alone (control group) is presented.Results: Patients with single-level (L1-S1) posterior or posterolateral disc herniation and radiologic confirmation of neural compression for whom at least six weeks of conservative treatment has failed are eligible. Patients must have posterior disc height ≥5 mm at index level and baseline Oswestry and VAS leg pain scores of ≥40/100. Intraoperatively, subjects meeting anular defect size criteria post-discectomy (4-6 mm tall and 6-10 mm wide) will be randomized to study groups in a 1:1 ratio using centralized, web-based software. A Bayesian statistical approach will be used to enroll 400 to 800 subjects who will be followed for at least 24 months. Two co-primary endpoints will be assessed at 24 months: 1) a composite of leg pain, clinical function, disc height maintenance, and absence of reherniation, reoperation, and device failure; and 2) absence of reherniation based upon independent radiologic analysis. Conclusions: This type of analysis is becoming increasingly important as governments and health insurers continue to be pressured to spend limited healthcare funding wisely.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

A multicenter, prospective, randomized study protocol to demonstrate the superiority of a bone-anchored prosthesis for anular closure used in conjunction with limited discectomy to limited discectomy alone for primary lumbar disc herniation

et al. 2016

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“…It was therefore with some incredulity that I read the paper by Siemionow [46] that it had been licensed by the FDA in 2005 for use, that licensing being withdrawn in 2007 after its predictable failure once again. The relevance of this paper is that any nuclear replacement that does not tension the annulus under load as well as axial loading, and thus transfer some of this load to the hard cortical periphery of the disc, (designed to take load), is doomed to fail.…”

Section: Disc Replacementmentioning

confidence: 99%

The Michel Benoist and Robert Mulholland yearly European Spine Journal Review

Mulholland

2013

Eur Spine J

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“…Cervical total disc replacement (TDR) was initially introduced in the 1960s with limited success due to complications including instability and prosthesis subsidence [ 3 ]. Renewed interest in TDR has been associated with the development of metal-on-metal and metal-on-polyethylene discs, and a number of these have been licenced by the United States Food and Drug Administration (FDA) [ 4 ].…”

Section: Introductionmentioning

confidence: 99%

A Retrospective Comparative Study of Long-Term Outcomes Following Cervical Total Disc Replacement Versus Anterior Cervical Discectomy and Fusion

Eseonu¹,

Laurent²,

Bishi³

et al. 2022

Cureus

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IntroductionThe traditional treatment for patients with radiculopathy and myelopathy caused by degenerative disc disease was anterior cervical discectomy and fusion (ACDF). However, a documented complication of ACDF is adjacent segment degeneration (ASD). An alternative that was developed was total disc replacement (TDR).The aim of this study was to determine and compare the short-and medium-to-long-term outcomes after a TDR or ACDF. MethodsA retrospective review of 154 patients who had single and two-level ACDFs and 90 TDRs performed by a single surgeon between 2011 and 2017 was conducted. Parameters for comparisons include both radiological evaluation and patient-reported outcome measures (PROMS) at six weeks, one year, and two years postoperatively. The Neck Disability Index (NDI) and the visual analogue scale (VAS) for neck and arm pain are used to evaluate pain, function, patient satisfaction, and overall clinical success. ResultsTDR and ACDF showed significant improvement in NDI and VAS when compared to pre-and postoperatively at both six weeks (p<0.05 & P=0.032, respectively) and two years (p<0.05 & 0=0.026, respectively). TDR vs. ACDF showed no significant difference (p<0.05). VAS scores after ACDF showed improvement from 13.41 to 3.94 at two years (p<0.001). TDR showed similar scores of 12.5 to 3.55 (p<0.001). The radiological fusion rate at 12 or 24 months showed no significant difference between the two groups. There were two cases that required re-operation after ACDF (1.2%), and two that required TDR (2.2%). ConclusionBoth TDR and ACDF lead to clinically significant improvements in pain and function scores. We did not find a statistically significant difference in NDI and VAS in the neck and arm.The results are in agreement with others' assessments of these two treatment modalities. Our conclusions supplement the literature about these operative options for degenerative disc disease of the cervical spine and are a useful addition to the armamentarium in the assessment of patients with degenerative pathology of the c-spine.

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The Fernstrom ball revisited

Cited by 13 publications

References 6 publications

A multicenter, prospective, randomized study protocol to demonstrate the superiority of a bone-anchored prosthesis for anular closure used in conjunction with limited discectomy to limited discectomy alone for primary lumbar disc herniation

A multicenter, prospective, randomized study protocol to demonstrate the superiority of a bone-anchored prosthesis for anular closure used in conjunction with limited discectomy to limited discectomy alone for primary lumbar disc herniation

The Michel Benoist and Robert Mulholland yearly European Spine Journal Review

A Retrospective Comparative Study of Long-Term Outcomes Following Cervical Total Disc Replacement Versus Anterior Cervical Discectomy and Fusion

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