Purpose of the study: The theoretical usefulness of a
We present data relating to the Bryan disc arthroplasty for the treatment of cervical spondylosis in 46 patients. Patients with either radiculopathy or myelopathy had a cervical discectomy followed by implantation of a cervical
Purpose of the study: Discectomy-anterior fusion has proven efficacy for many diseases of the cervical spine. Nevertheless, the loss of motion and the over-solicitation of adjacent levels are arguments in favor of disc replacement. This prospective study examined the early clinical and radiological results obtained in the first 41 patients treated with a new cervical
Introduction: There is a great deal of interest in intervertebral disc arthroplasty. These devices have been used in Europe for more than 10 years. There have been several reports published on the European results when using the SB Charité III (link) prosthesis and good results have been reported in 63% to 79% of patients. 1,. 2,. 3. The purpose of this prospective study was to evaluate surgical outcome following implantation of an artificial disc. Methods: The SB Charité III device has two cobalt chromium plates with a polyethylene core between them. Motion occurs through articulation between the concave/convex surfaces of the plates and core. The
Purpose of the study. In a recent study, O'Leary et al. [2005] reported their observations on the patterns of Charité
Objective: Movement in an artificial disc would be assumed to be a necessary function of the disc. The purpose of this study was to establish whether, if any, relationship existed between movement in the artificial disc and outcome. Subjects: 25 patients who had received an artificial
Introduction: The Charite Mark 3
Introduction The early clinical results of cervical disc replacement surgery are encouraging but the in vivo kinematics of prostheses remains poorly understood. Two recent published reports suggest that use of a prosthesis with an unconstrained (over normal range of motion) biconvex nucleus (Bryan Cervical Disc® – Medtronic Sofamor Danek, Memphis, TN) can be associated with post-operative segmental kyphosis. This study examines post-operative kyphosis and segmental imbalance following cervical disc replacement using the Bryan Cervical
Fusion has been the surgical reference for treating degenerative disc disease, nevertheless in the last two decades the recognition of it’s inconvenients, such as the degenerescence of the adjacent level, the growing demand for a better life quality by the patients and the evolution of the knowledge regarding the biomechanics of the spine and of the intervetebral disc itself, have stimulated the development of new technologies for the treatment of DDD among which the Disc Replacement. In this symposium will be analysed the biomechanics of the disc and disc replacement, enhancing the already known benefits of the movement preservation, by discussing the different philosophies of the available systems: non-constraint; semi-constraint; and constraint. The analysis of the overview results in the literature of fusion in comparison with disc replacement will also proportionate a fundamental actualization when deciding over the current perspectives in the treatment of DDD, considering the treatment alternatives developed in the meanwhile. The disc replacement is an actual challenge with believers all over the world as an important step forward towards better life quality of patients with incapacitant low back pain. But with indications and limits that must be well known. Besides that it’s a demanding technique with potential risks associated and that demands specialization in this domain for its practice. Always considering the different phases of evolution of the DDD, which can occur simultaneously in the same patient, different therapeutics solutions are considerate and which application deserves a profound reflexion according to the diagnosis characteristics, its staging, the ponderation of risks and benefits and as well its socioeconomics consequences.
Sixty-one lumbar disc replacements in 50 consecutive patients were performed between June 2001 and October 2002. The mean age of the patients was 42.42 years (24 to 61). All presented with mechanical back and/or leg pain. The primary diagnosis was degenerative disc disease. Three patients underwent fusions of another level during the same operation. Seven patients presented with adjacent level disc disease after previous instrumented posterolateral fusion. The mean postoperative hospital stay was 3.6 days (2 to 8). One patient with a double-level disc replacement and misplacement of the proximal prosthesis underwent revision surgery three days later. Six patients had subsidence on one of the endplates, all within six weeks postoperatively. All but one patient went back to their previous occupation at a mean time of 26 days (7 to 91). Patients completed questionnaires at 3, 6, 12 and 24 months postoperatively. In the latest follow-up questionnaire, 47 patients said they were satisfied or very satisfied. Forty-five patients would undergo the same operation again or recommend it to friends, two patients were uncertain and two indicated they would not undergo the procedure again. One patient from another country was lost to follow-up, but a telephonic enquiry six months after surgery suggested that he was doing well. Although our follow-up period is short, the clinical results compare favourably to those in the literature. The rate of immediate subsidence, which seems to be linked to the anchoring teeth, is of concern.
The results demonstrate that the failure modes of the device contain sufficient safety margins to support the use of the device in a prospective clinical study.
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. 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.Introduction
Material and methods
As a relatively new technique, there is little in the literature regarding patient satisfaction with this device and there are no long term trials defining the most appropriate indication for this device nor benefits over alternative and more conventional procedures such as discectomy and fusion. This study aimed to quantify the degree of disability and functional limitation in patients selected for Bryan disc replacement both pre-operatively and from 3 months post-operatively.
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. 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.Introduction
Material and methods
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. 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.Introduction
Material and methods
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. 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.Introduction
Material and methods
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.
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:
Introduction The current study was undertaken to investigate the biomechanical and biologic in-growth characteristics of the Porous Coated Motion™ cervical