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The Bone & Joint Journal
Vol. 101-B, Issue 12 | Pages 1526 - 1533
1 Dec 2019
Endler P Ekman P Berglund I Möller H Gerdhem P

Aims

Chronic low back pain due to degenerative disc disease is sometimes treated with fusion. We compared the outcome of three different fusion techniques in the Swedish Spine Register: noninstrumented posterolateral fusion (PLF), instrumented posterolateral fusion (IPLF), and interbody fusion (IBF).

Patients and Methods

A total of 2874 patients who were operated on at one or two lumbar levels were followed for a mean of 9.2 years (3.6 to 19.1) for any additional lumbar spine surgery. Patient-reported outcome data were available preoperatively (n = 2874) and at one year (n = 2274), two years (n = 1958), and a mean of 6.9 years (n = 1518) postoperatively and consisted of global assessment and visual analogue scales of leg and back pain, Oswestry Disability Index, EuroQol five-dimensional index, 36-Item Short-Form Health Survey, and satisfaction with treatment. Statistical analyses were performed with competing-risks proportional hazards regression or analysis of covariance, adjusted for baseline variables.


The Bone & Joint Journal
Vol. 101-B, Issue 4 | Pages 470 - 477
1 Apr 2019
Fjeld OR Grøvle L Helgeland J Småstuen MC Solberg TK Zwart J Grotle M

Aims

The aims of this study were to determine the rates of surgical complications, reoperations, and readmissions following herniated lumbar disc surgery, and to investigate the impact of sociodemographic factors and comorbidity on the rate of such unfavourable events.

Patients and Methods

This was a longitudinal observation study. Data from herniated lumbar disc operations were retrieved from a large medical database using a combination of procedure and diagnosis codes from all public hospitals in Norway from 1999 to 2013. The impact of age, gender, geographical affiliation, education, civil status, income, and comorbidity on unfavourable events were analyzed by logistic regression.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_8 | Pages 57 - 57
1 Apr 2017
Aragonés M Hevia E Caballero A Barrios C
Full Access

Background. The controversy concerning the benefits of unisegmental cervical disc arthroplasty (CDA) over anterior cervical discectomy and fusion (ACDF) is still open because some randomised clinical trial (RTC) comparing ACDF with CDA have been highly inconclusive. Most of these studies mixed disc prosthesis with dissimilar kinematic characteristics. To date, a compilation of the clinical and radiologic outcomes and adverse events of anterior cervical discectomy and fusion (ACDF) compared with a single cervical disc arthroplasty (CDA) design, the Bryan disc has partially accomplished. Methods. This is a systematic review of RCTs with level I-II evidence. Only RCTs reporting clinical outcomes were included in this review. After a search on different databases including PubMed, Cochrane Central Register of Controlled Trials, and Ovid MEDLINE, a total of 10 RCTs out of total 51 studies were entered in the study. RTC's were searched from the earliest available records in 2005 to December 2014. Results. Five studies were Level I, and five were Level II. Out of a total of 1101 patients, 562 patients were randomly assigned into the Bryan arthroplasty group and the remaining 539 patients into the ACDF group. The mean follow-up was 30.9 months. Patients undergoing CDA had lower Neck Disability Index, and better SF-36 Physical component scores than ACDF patients. Patients with Bryan CDA had also less radiological degenerative changes at the upper adjacent level. Overall adverse events were twice more frequent in patients with ACDF. The rate of revision surgery including both adjacent and index level were slightly higher in patients with ACDF, showing no statistically significant difference. Conclusions. This review of evidence level I-II RCTs comparing clinical and radiological outcomes of patient undergoing Bryan arthroplasty or ACDF indicated a global superiority of the Bryan disc. The impact of both surgical techniques on the cervical spine (radiological spine deterioration and/or complications) was more severe in patients undergoing ACDF. However, the rate of revision surgeries at any cervical level was equivalent for ACDF and Bryan arthroplasty. These data suggest that even though the loss of motion has a determinant influence in the development of degenerative changes in ACDF cases, these kinematic factors do not imply a higher rate of symptomatic adjacent segment degeneration requiring surgery. Level of Evidence. Level I


Introduction

The ESP prosthesis is a one-piece deformable but cohesive interbody spacer. it provides 6 full degrees of freedom about the 3 axes including shock absorption (fig1). The prosthesis geometry allows limited rotation and translation with resistance to motion (elastic return property) aimed at avoiding overload of the posterior facets. The rotation center can vary freely during motion in this “silentblock” implant. It thus differs substantially from current prostheses.

Material and methods

Surgeries were performed by 2 senior surgeons in 54 women and 34 men (1level in 72 cases, 2 levels in 3 cases, hybrid construct in 13 cases). Average age was 42 (SD: 7). Average BMI was 24.2kg/m2 (SD: 3,4). Clinical data and X-rays were collected at the preoperative time and at 3, 6, 12, 24, and 60 months post-op. The analysis was performed by a single observer independent from the selection of patients and from the surgical procedure.

The radiological analysis at 60 months follow-up could be realized in only 76 cases because the quality of the dynamic Xrays was not sufficient in 12 patients. We measured the ROM and the location of mean center of rotation (MCR) of the implanted and adjacent levels using the Spineview® software. The MCR is considered to reflect the quality of movement of a segment; it is localized thanks its co-ordinates. X is expressed as a percentage of the length of the vertebral end plate, and Y as a percentage of the height of the posterior wall. The usual location of the MCR is in a circle, whose center is placed between 30 and 50% of the superior vertebral endplate of the vertebra below, and whose diameter is 70% of the vertebral endplate size.


The Bone & Joint Journal
Vol. 98-B, Issue 6 | Pages 829 - 833
1 Jun 2016
Hou Y Nie L Pan X Si M Han Y Li J Zhang H

Aims

In order to evaluate the effectiveness of the Mobi-C implant in cervical disc degeneration, a randomised study was conducted, comparing the Mobi-C prosthesis arthroplasty with anterior cervical disc fusion (ACDF) in patients with single level cervical spondylosis.

Patients and Methods

From January 2008 to July 2009, 99 patients were enrolled and randomly divided into two groups, those having a Mobi-C implant (n = 51; 30 men, 21 women) and those undergoing ACDF (n = 48; 28 men, 20 women).The patients were followed up for five years, with the primary outcomes being the Japanese Orthopaedic Association score, visual analogue scale for pain and the incidence of further surgery. The secondary outcomes were the Neck Disability Index and range of movement (ROM) of the treated segment.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_2 | Pages 139 - 139
1 Jan 2016
Lazennec JY Brusson A Ricart O Rakover JP
Full Access

Introduction

The viscoelastic cervical disk prosthesis ESP is an innovative one-piece deformable but cohesive interbody spacer. It is an evolution of the LP ESP lumbar disk implanted since 2006. CP ESP provides 6 full degrees of freedom about the 3 axes including shock absorption. The prosthesis geometry allows limited rotation and translation with resistance to motion (elastic return property) aimed at avoiding overload of the posterior facets. The rotation center can vary freely during motion (figure 1)

It thus differs substantially from current prostheses. This study reports the results of a prospective series of 49 patients who are representative of the current use of the ESP implant since 2012.

Material and methods

The surgeries were performed by 3 senior surgeons. There were 34 women and 15 men in this group. The average age was 44±7 (32–59). The implantation was single level in 78 % of cases. 55 CP ESP prostheses were analyzed.

Clinical data and X-rays were collected at the preoperative time and at 3, 6, and 12 months post-op.

The functional results were measured using Neck and Arm VAS, NDI, SF-36, (physical componentPCS and mental component MCS). The analysis was performed by a single observer who was independent from the selection of patients and from the surgical procedure.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 389 - 389
1 Dec 2013
Lazennec JY Brusson A Rakover JP Rousseau M
Full Access

Introduction

The viscoelastic lumbar disk prosthesis ESP is an innovative one-piece deformable but cohesive interbody spacer; it provides 6 full degrees of freedom about the 3 axes including shock absorption. The prosthesis geometry allows limited rotation and translation with resistance to motion (elastic return property) aimed at avoiding overload of the posterior facets. The rotation center can vary freely during motion. It thus differs substantially from current prostheses. This study reports the results of a prospective series of 120 patients who are representative of the current use of the ESP implant since 2006.

Material and methods

The surgeries were performed by 2 senior surgeons. There were 73 women and 47 men in this group. The average age was 42 (27–60). The average body mass index was 24.2 kg/m2 (18–33). The implantation was single level in 89% of cases. 134 ESP prostheses were analyzed.

Clinical data and X-rays were collected at the preoperative time and at 3, 6, 12, 24, and 36 months post-op.

The functional results were measured using VAS, GHQ 28, ODI, SF-36, (physical component PCS and mental component MCS. The analysis was performed by a single observer who was independent from the selection of patients and from the surgical procedure.


The Bone & Joint Journal
Vol. 95-B, Issue 1 | Pages 81 - 89
1 Jan 2013
Johnsen LG Brinckmann P Hellum C Rossvoll I Leivseth G

This prospective multicentre study was undertaken to determine segmental movement, disc height and sagittal alignment after total disc replacement (TDR) in the lumbosacral spine and to assess the correlation of biomechanical properties to clinical outcomes.

A total of 173 patients with degenerative disc disease and low back pain for more than one year were randomised to receive either TDR or multidisciplinary rehabilitation (MDR). Segmental movement in the sagittal plane and disc height were measured using distortion compensated roentgen analysis (DCRA) comparing radiographs in active flexion and extension. Correlation analysis between the range of movement or disc height and patient-reported outcomes was performed in both groups. After two years, no significant change in movement in the sagittal plane was found in segments with TDR or between the two treatment groups. It remained the same or increased slightly in untreated segments in the TDR group and in this group there was a significant increase in disc height in the operated segments. There was no correlation between segmental movement or disc height and patient-reported outcomes in either group.

In this study, insertion of an intervertebral disc prosthesis TDR did not increase movement in the sagittal plane and segmental movement did not correlate with patient-reported outcomes. This suggests that in the lumbar spine the movement preserving properties of TDR are not major determinants of clinical outcomes.

Cite this article: Bone Joint J 2013;95-B:81–9.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 273 - 273
1 Sep 2012
Lazennec JY Rakover JP Aaron A Pascal Mousselard H Rousseau MA
Full Access

Introduction

Current artificial discs include 1 or 2 bearing surfaces, providing 3 or 5 degrees of freedom. The ESP® is a one-piece e implant made of silicon and polycarbonate -urethane securely fixed to titanium endplates. It allows limited rotation and translation with elastic return. This cushion without fixed rotation center achieves 6 degrees of freedom including shock absorption. This objective of this study was to evaluate the safety and efficacy of the concept in a prospective nonrandomized trial.

Material and methods

Prior to clinical implantations, the device was endurance tested at least 40 millions cycles. The polymer core weight and properties, the geometrical characteristics and cohesion of the implants remained stable.

A prospective trial was initiated in 2004 for L3L4, L4L5 and L5S1 levels. Total disc replacements have been performed in 153 lumbar levels through extra-peritoneal mini-invasive anterior approach with a minimum 2 years follow-up.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XVII | Pages 49 - 49
1 May 2012
Munigangaiah S Cronin K McCabe J
Full Access

Background. There have been limited published reports on the clinical results of cervical artificial disc replacement. Goffin et al reported a 90% rate of good to excellent results at 1 to 2 yrs after Bryan disc replacement. Wigfield et al reported a 46% improvement in pain and 31% improvement in disability 2 yrs after Prestige cervical disc replacement. Objectives. The study was designed to determine whether new functional cervical disc prosthesis can provide improvement in the ability to perform activities of daily living, decrease pain and segmental motion. Methods. All patients who had Prestige cervical disc replacement over last 2yrs 3 months were identified. Oswestry disability index score and SF36 Quality of life instrument were administered to each patient. Site specific pain scores were obtained using visual analogue scale. Clinical and operative details were reviewed and correlated. Results. 35 Patients underwent 48 Prestige cervical disc replacement during study period. There was 48%, 54% and 70% improvement in Oswestry disability index at 6 weeks, 6 months and 19 months follow-ups respectively. There was significant improvements in both neck and arm pain during immediate post op period and during further follow-ups. There was one neck wound haematoma and one left sided Horner's syndrome as complications. Conclusion. Anterior cervical disc replacement is a viable surgical alternative to fusion for cervical disc degenerative disease and herniation with preservation of motion and alignment without compromising clinical outcomes. At least 5yrs follow-up will be needed to assess the long term functionality of the prosthesis and protective influence on the adjacent levels


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_X | Pages 65 - 65
1 Apr 2012
Herdmann J Buddenberg P Rhee S Pilz A Floeth F
Full Access

The aim of most new implants for cervical disc replacement is to maintain or restore function. The Dynamic Cervical Implant (DCI(tm), Paradigm Spine) aims at combining the advantages of the gold standard fusion technique with the motion preservation philosophy. DCI has a limited motion: it works like a shock absorbing spring and may help to slow down adjacent segment degeneration. Between 2007 and 2009 we selected 79 patients aged 32 to 73 years for treatment with DCI at either one or two levels (10 patients). Indications were radiculopathies (n=45), axial pain (n=4) or spondylotic spinal stenosis (n=30) with out chronic myelopathy. Patients are followed up at 3, 6, and 12 months after surgery. Disc surgery was performed at C3/C4 (n=2), C4/5 (n=6), at C5/6 (n=43), C6/7 (n=37) and at C7/T1 (n=1). In flexion/extension radiographs motion rapidly increased after surgery. However, 5 of 19 treated levels were fused (seen at 6 or 12 months). After implant footprint was changed and larger sizes were provided only 2 of 67 segments fused. Still 96% of the patients rated their clinical result as excellent or good. There were no implant related complications or revision surgery. Disc replacement with DCI is a new strategy that is positioned in between anterior cervical fusion and disc prosthesis. Clinical results are as good as in anterior cervical fusion. Adjacent segment protection must be judged in future follow-ups. We were able to show that the change of implant footprint has significantly reduced fusion rate


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_III | Pages 98 - 98
1 Feb 2012
Ross R Harris J Oxborrow N Patwardin A Dashti H
Full Access

Purpose of the study. In a recent study, O'Leary et al. [2005] reported their observations on the patterns of Charité disc prosthesis motion under physiologic loads. The purpose of this study was to investigate whether the motion patterns observed in the in vitro model are replicated in clinical practice. Methods. 55 patients with implanted SB Charité 111 artificial lumbar discs were subjected to flexion extension x-rays. Two consultant spinal surgeons and a neuro-radiological consultant were asked to classify the pattern of motion in the clinical subjects based on the patterns observed in the in vitro model. The results were recorded independently then collated. Following this first round of observations an algorithm was devised and the method of measurement was standardised. Summary of findings: There was modest correlation amongst the three observers in distinguishing motion from nonmotion (Kappa 5.6). There was less agreement on what type of motion was present. On both counts using the algorithm there was no correlation. The clinical study based on patients' flexion-extension radiographs identified the following patterns of prosthesis motion:. angular motion between both the upper and lower endplates and core, with visual evidence of core motion;. angular motion predominantly between the upper endplate and core, with little visual evidence of core motion;. lift-off of upper prosthesis endplate from core or of core from lower endplate;. core entrapment and deformation; and. no motion. There are difficulties associated with the interprtation of these using only flexion extension views. Conclusions. In devising artificial discs the requirement would be to replicate spinal motion as closely as possible. O'Leary et al have found non-physiological motions in in vitro models. These have been found in this clinical study but interobserver correlations were far from conclusive. Demonstrating non physiological patterns may have important implications for outcome


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 515 - 515
1 Nov 2011
Allain J Delécrin J Beaurain J Ketani O Aubourg L Samaan M Roudot-Thoraval F
Full Access

Purpose of the study: Indications for disc prosthesis is generally established on the basis of the MRI findings (MODIC classification) and the discography. We considered that knowledge of the preoperative disc height is also important. We report a multicentric study of the results of lumbar arthroplasties as a function of preoperative height of the operated disc. Material and methods: A Mobidisc prosthesis was implanted in 93 patients and followed prospectively for at least one year (mean follow-up 5 years). Disc height was compared with the height of the suprajacent disc and divided into three groups: > 66% of height (GI) i.e. a subnormal disc height (n=30), 33–66% (GII) moderate impingement (n=36), < 33% (GIII) total impingement (n=27). A MODIC signal was found for 19% in GI, 42% in GII and 40% in GIII. Results: The lumbar VAS improved from 6.7 to 3.2 (GI), 6.2 to 2 (GII) and 6.2 to 1.5 (GIII). The radicular VAS improved from 4.8 to 3.1 (GI), 5.7 to 2.4 (GII) and 5.5 to 1.6 (GIII), respectively 69, 75 and 85.5% of the patients were satisfied or very satisfied for relief of the lumbar or radicular pain. The Oswestry score improved from 50 to 22% (GI), 49 to 20% (GII) and 46 to 12% (GIII). By MODIC, the lumbar VAS improved from 6.5 to 2.8 (MODIC 0) and from 6.6 to 2 (MODIC 1). The radicular VAS was improved from 5.5 to 2.9 (MODIC 0) and from 5.3 to 2.1 (MODIC 1). The Oswestry score was improved from 52 to 24% (MODIC 0) and from 48 to 15% (MODIC 1). Independently of MODIC, the VAS was always better for very tight discs and lower if the disc height was preserved. Discussion: An influence of the disc height was found for all parameters studied, irrespective of the type of disc disease as described by the MODIC classification. The presence of a tight preoperative disc height appeared as the essential prognostic factor for discal prostheses. For a MODIC 0 discopathy, without loss of disc height, only 67 and 61% of the operated patients were satisfied or very satisfied with relief of lumbar and radicular pain (VAS 3.6 and 3.4) for respectively 88 and 75% of the MODIC0 discopathies with discal impingement (VAS 1.5 and 1.5). Though it should not be formally ruled out, surgery for discopathy with a preserved disc height should be examined prudently before implanting a disc prosthesis


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 165 - 165
1 Mar 2010
Lazennec YY
Full Access

Introduction: Current total disc prostheses are 2- or 3-pieces devices, including 1 or 2 bearing surfaces, and providing 3 or 5 degrees of freedom but with no, or very little, resistance. The ESP® is a one-piece deformable implant made of silicon and polycarbonate polyurethane elastomer securely fixed to titanium endplates. It allows limited rotation and translation with elastic return. This cushion without fixed rotation center achieves 6 degrees of freedom including shock absorption. An earlier attempt to use elastomers (Acroflex®) failed clinically due to the polymer. This highlights the need for accurate in-vitro fatigue testing and clinical evaluations.

Methods: In-vitro fatigue testing with more than 40 millions cycles were performed on different samples for compression, flexion-extension bending, lateral bending, torsion and shear. A prospective trial was initiated in 2004 for L3L4, L4L5 and L5S1 levels. Total disc replacements have been performed in 153 lumbar levels through extra-peritoneal mini-invasive anterior approach

Results: After in-vitro testing, microscopic examination showed that the polymer core remained unchanged without evidence of cracking or other degradation. Gravimetric analysis revealed insignificant changes in weight. The geometrical characteristics and the cohesion of the implants remained stable. After 3 years clinical experience, there was no device related complication, except one early revision for a post-traumatic implant migration. VAS and ODI scores improvements were equivalent to other published series.

Discussion and Conclusion: In-vitro fatigue testing and short term results of the innovative ESP® prosthesis demonstrate the reliability of the concept. The results are equivalent to other series with conventional implants.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 134 - 134
1 Mar 2010
Kim SW Limson MA Kim SB Arbatin JJF Park MS Shin JH Ju YS
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Background: Cervical myelopathy and radiculopathy has been treated commonly with anterior cervical decompression and fusion with autologous bone graft and anterior cervical plating. Long term results have shown excellent pain relief and 73%–90% fusion rates. However, the development of late adjacent-level disease has been reported following anterior cervical arthrodesis which recently have been correlated to clinical findings. The Bryan disc arthroplasty device was developed to preserve the kinematics of the functional spine unit thus preventing adjacent level disease. There have been few studies comparing the incidence of adjacent level changes in patients undergoing ACDF compared to implantation of a Bryan disc arthroplasty device. Objectives: The object of this study is to compare the clinical results and radiographic outcomes of anterior cervical decompression and fusion versus cervical disc replacement using the Bryan Cervical Disc Prosthesis (Medtronic Sofamor Danek, Memphis, TN) in terms of overall range of motion (ROM) of the cervical spine; ROM, anterior intervertebral height (AIH), posterior intervertebral height (PIH) and radiographic changes at the implanted and adjacent levels. Methods: The study consisted of 105 patients with symptomatic single or two-level cervical disc disease. Fifty-one received the Bryan Cervical Artificial Disc Prosthesis (Medtronic Sofamor Danek, Memphis, TN). A total of 63 Bryan disc were placed in these 51 patients. A single-level procedure was performed in 39 patients and a two-level procedure in the other twelve. The patient group who underwent ACDF totaled 54 patients which consisted of 26 single level cases and 28 double level cases. The Bryan group had a mean follow-up 19 months (12–38). The mean follow-up for the ACDF group was 20 months (12–40 months). All patients were evaluated using static and dynamic cervical spine radiographs as well as MR imaging. All patients underwent anterior cervical discectomy followed by anterior cervical plating or implantation of the Bryan artificial disc prosthesis, done by one surgeon. Clinical evaluation included the visual analogue scale (VAS), and neck disability index (NDI). Radiographic evaluation included static and dynamic flexion-extension radiographs in an upright position using the computer software (Infinitt PiviewSTAR 5051) program. Range of motion/disc space angle and inter vertebral height were measured at the operative site and adjacent levels. Functional spinal unit (FSU) and overall sagittal alignment (C2–C7) were also measured pre-operatively, postoperatively and at final follow-up. ROM was calculated for all 3 areas and data collected were compared from pre operative to last follow-up as well as between the two groups. Radiographic assessment for adjacent level changes was also done. Radiologic change was analyzed using chi square test (95% confidence interval). Other data were analyzed using the mixed model. (SAS enterprise guide 4.1 version). Results: There was clinical improvement within each group in terms of VAS and NDI scores from pre-op to final follow-up for both single (VAS: p=0.8371, NDI: p=0.2872) and double (VAS: p=0.2938, NDI: p=0.6753) level surgeries but not significantly between the two groups. Overall, ROM and intervertebral height was relatively well maintained during the follow-up in the Bryan group compared to ACDF. Comparing the pattern of ROM measurements from pre-op to final follow-up between the two arms regardless of the number of levels operated on; significant differences were noted for overall ROM of the cervical spine (p< .0001) and all other levels except at the upper level for single level surgeries (p=0.2872). In terms of inter vertebral height measurements from pre-op to final follow-up, statistically significant (p< 0.0001 and p=0.0172) differences in the pattern between the two groups were noted at all levels except for the AIH of single level surgeries at the upper (p=0.1264) and lower (p=0.7598) levels as well as PIH for double level surgeries at the upper (p=0.8363) level. Radiologic change was 3.5 times more observed for the ACDF group compared to the Bryan group. Conclusion: Clinical status of both groups, regardless of the number of levels, showed improvement. Although clinical outcomes between the two groups were not significantly different at final follow-up, radiographic parameters, namely ROM and intervertebral heights at the operated site, some adjacent levels as well as FSU and overall sagittal alignment of the cervical spine were relatively well maintained in our Bryan group compared to our ACDF group. We surmise that to a certain degree, the maintenance of these parameters could contribute to reduce development of adjacent level change. Noteworthy is that radiographic change was 3.5 times more observed for ACDF surgeries. A longer period of evaluation is needed, to see if all these radiographic changes will translate to symptomatic adjacent level disease


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 133 - 133
1 Mar 2010
Moon E Kim J Kim N Park J Park S Kim H Kim H Lee H Moon S
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Many reports show good results following procedures, such as intervertebral body fusion using cage or total disc replacement, that restore adequate disc height. However, there have been no references regarding the range of normal lumbar disc height in Korean adults which can be used as a standard for the implant size. The purpose of our study is to measure the lumbar disc height on radiographs in normal Korean. 132 subjects (age range 20 to 40 years) who had no previous history of low back pain and no significant finding on physical examination were enrolled. Plain lateral lumbar spine radiograph in supine position were taken. Intervertebral disc heights were measured at anterior, middle and posterior portion of each lumbar disc. The average magnification rate was 115%, and the disc heights were corrected by the magnification rate in each segment. Lumbar disc height showed cranio-caudal pattern in both male and female groups. L4–5 disc heights were highest at anterior, middle and posterior portion in male. L4–5 disc heights were highest at middle and posterior portion in female. L5-S1 disc height was highest at anterior portion in female, but there was no statistically significant difference between L4–5 and L5-S1 disc height at anterior portion. There was no significant difference in disc height between male and female except anterior portion of L1–2 and L2–3 disc. Statistically significant decrease in disc height was not presented in overweight person at all measured site in male and female except posterior portion of L1–2 disc in male. This research is meaningful in that it is an attempt to provide a reference value of lumbar disc height in Korean adults, and the measured values may also be useful in manufacturing Korean modeled artificial lumbar disc prosthesis or surgical instruments for lumbar interbody fusion


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 132 - 132
1 Mar 2010
Lazennec J Pascal-Mousselard H Ricart O Rakover J Rousseau M Aaron A
Full Access

Current total disc prostheses are 2- or 3-pieces devices, including 1 or 2 bearing surfaces, and providing 3 or 5 degrees of freedom but with no, or very little, resistance. The ESP® is a one-piece deformable implant made of silicon and polycarbonate polyurethane elastomer securely fixed to titanium endplates. It allows limited rotation and translation with elastic return. This cushion without fixed rotation center achieves 6 degrees of freedom including shock absorption. An earlier attempt to use elastomers (Acroflex®) failed clinically due to the polymer. This highlights the need for accurate in-vitro fatigue testing and clinical evaluations.

In-vitro fatigue testing with more than 40 millions cycles were performed on different samples for compression, flexion-extension bending, lateral bending, torsion and shear. A prospective trial was initiated in 2004 for L3L4, L4L5 and L5S1 levels. Total disc replacements have been performed in 153 lumbar levels through extra-peritoneal mini-invasive anterior approach.

After in-vitro testing, microscopic examination showed that the polymer core remained unchanged without evidence of cracking or other degradation. Gravimetric analysis revealed insignificant changes in weight. The geometrical characteristics and the cohesion of the implants remained stable. After 3 years clinical experience, there was no device related complication, except one early revision for a post-traumatic implant migration. VAS and ODI scores improvements were equivalent to other published series.

In-vitro fatigue testing and short term results of the innovative ESP® prosthesis demonstrate the reliability of the concept. The results are equivalent to other series with conventional implants.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_III | Pages 463 - 463
1 Sep 2009
Dakhil-Jerew F
Full Access

Introduction: ACDF involves cancellation of the diseased spinal motion segment, the neighboring spinal segments take the burden of excessive compensatory spinal movements and strain resulting in early degeneration. Adjacent segment degeneration with new, symptomatic radiculopathy occurs after ACDF in 2–3% of patients per year on cumulative basis. An estimated 15% of patients ultimately require a secondary procedure at an adjacent level. An alternative to fusion is total disc arthroplasty (TDA). The key advantage of this promising technology is restoration and maintenance of normal physiological motion rather than elimination of motion. We describe 4 patients with a serious complication observed following implantation of the Bryan disc prosthesis in our cohort of 48 patients. Material and Results:. Patient #1: 43 M, with neck pain & left brachalgia, with left C6 dermatome signs, with MRI findings of C5/6 disc prolapse with left C6 root impingement, undergoing C5/6 Bryan TDA in April 2004, with treatment recommendation of C3/4 and C6/7 Bryan TDA in January 2006. Patient #2: 47 M, with worsening gait over 2 years with right brachalgia, with findings of progressive cervical myelopathy with right C5 radiculopathy, with MRI findings of severe C5/6 disc degeneration with spinal cord compression, undergoing C5/6 Bryan TDA in January 2003, with MRI FU findings after 16/12 with new left C6/7 disc prolapse and left C6 radiculopathy, with treatment recommendation of C6/7 Bryan TDA, on waiting list. Patient #3: 45 F, 6 years of neck pain with right brachialgia, with right C5 dermatome signs, with MRI findings of C5/6 central disc herniation with cord compression, undergoing C5/6 Bryan TDA in December 2000, with FU MRI showing after 5 years and 7/12 (67/12) new C6/7 canal narrowing with right C6 radiculopathy, and treatment recommendation of C6/7 Bryan TDA. Patient #4: 38 M, worsening gait over 5 years and exam findings of progressive cervical myelopathy, with MRI findings of severe C5/6 disc degeneration with spinal cord compression, undergoing C5/6 Bryan TDA in August 2003, with FU MRI showing after 3 years new C4/5 disc prolapse with C5 radiculopathy, followed by treatment recommendation of C4/5 Bryan TDA. Discussion & Conclusions: Bryan TDR did not prevent the development of accelerated ASD. Evidence from in vivo X ray studies suggested that the range of motion across the operated levels did not match the physiological ROM. Despite the MRI images preoperatively, it is difficult to exclude the natural progression of degeneration as a reason for ASD


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_III | Pages 455 - 455
1 Aug 2008
Emran IM Badawy W Badge R Hourigan P Chan D
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Objective: To assess the effectiveness of total disc replacement (TDR) (Charité SB III) for treatment of lumbar discopathy and to report the preliminary clinical results after a minimum follow-up period of two years. Materials and Methods: From 49 patients who underwent lumbar TDR, 31 patients fulfilled the criteria for clinical evaluation at least 2 years after surgery. The mean age was 39ys (range 29 – 48). Preoperative diagnosis included degenerative disc disease in 27 patients and 4 patients had post discectomy back pain. 44 disc prosthesis were implanted, 18 patients had a single level disc replacement and 13 patients had two level replacement. All patients were studied prospectively and clinical results evaluated by assessing preoperative and postoperative Oswestry Disability Index questionnaire and Visual Analogue Scale for back pain. Pre and postoperative patients’ work status as well as patient satisfaction were also assessed. The mean postoperative follow up was 3.3years (range 2 – 8 years). Statistical analysis of the results was done with the Wilcoxon Signed Ranks Test. Results: There were significant improvements of the clinical outcome measures. Mean post operative ODI compared to mean preoperative scores of 19 and 53 respectively (p< 0.0001) and mean postoperative VAS compared to mean preoperative scores of 2.5 and 7.5 respectively (p< 0.0001). Success rates showed 51.6% of patients had an excellent result (relative improvement of ODI score, > 75%), 19.4% had a good result (relative improvement of ODI score, 60% to74%), and 29% had a fair and poor results (relative improvement of ODI score, < 60%). No major or approach related complications were encountered. Conclusions: TDR is an effective method of treating discopathic low back pain. The medium term results are comparable to those obtained following traditional lumbar arthrodesis. Yet longer term results are still needed to comment on adjacent segment load transfer and progression of degenerative changes


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_II | Pages 235 - 235
1 Jul 2008
WAJSFISZ A RILLARDON L JAMESON R DRAIN O GUIGUI P
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Purpose of the study: Conventional treatment for recurrent lumbar disc herniation is repeated discectomy. Other methods such as fusion, ligamentoplasty or implantation of a discal prosthesis are sometimes proposed but all increase morbidity. The purpose of this work was to ascertain the efficacy of isolated repeated radicular release for the treatment of recurrent discal herniation. Material and methods: Thirty-four patients underwent surgery for recurrent discal herniation. Repeated radicular release was used in all patients included in this analysis who completed a self-administered questionnaire at last follow-up to assess the final functional outcome. Results: The cohort included 13 women and 21 men, mean age at surgery 45 years. Mean time from first discectomy to revision surgery for recurrence was 55 months. At the time of the review, four patients had died, all four from cancer. None of these patients had undergone a revision procedure on the lumbar spine. One patient was lost to follow-up so 85% of the cohort was analyzed with 60 months average follow-up. A dural tear occurred during the proscedure in six patients (17%. Five patients (14.7%) required revision surgery, one for deep infection, four for recurrent or persistent lumboradiculalgia (recurrent discal herniation, isthmic fracture, lateral stenosis associated with inflammatory discopathy). The rate of revision for painful failure was 11.4%. The final outcome could be assessed for 25 patients and was satisfactory for 22/25 (88%). The self-administered questionnaire revealed 65% average improvement with more than half of the patients reported better than 80% improvement. Ten patients (40%) complained of lumbar pain and a third had residual, generally intermittent, radiculalgia. Eighteen of 25 patients resumed their work at a comparable level after six months on average; 84% of the patient would accept the same operation again. Discussion: In terms of morbidity and rate of revision, the results are comparable to reports in the literature. Repeated release does not increase the risk of a new recurrence. Conclusion: This work enabled us to demonstrate that in the large majority of patients repeated discectomy provides satisfactory functional outcome with little morbidity