Lumbar Disc Prosthesis Research Articles

Five-year results of lumbar disc prostheses in the SWISSspine registry.

The Swiss Federal Office of Public Health demanded a nationwide HTA registry for lumbar total disc arthroplasty (TDA), to decide about its reimbursement. The goal of the SWISS spine registry is to generate evidence about the safety and efficiency of lumbar TDA. Two hundred forty-eight cases treated between 3-2005 and 6-2006, who were eligible for the 5-year follow-up were included in the study. Follow-up rates for 3-6 months, 1, 2 and 5 years were 85.9, 77.0, 44.0 and 51.2 %, respectively. Outcome measures were back and leg pain, medication consumption, quality of life, intraoperative and postoperative complication and revision rates. Additionally, segmental mobility, ossification, adjacent and distant segment degeneration were analysed at the 5-year follow-up. There was a significant, clinically relevant and lasting reduction of back (preop/postop 73/29 VAS points) and leg pain (preop/postop VAS 55/22) and a consequently decreased analgesics consumption and quality of life improvement (preop/postop 0.30/0.76 EQ-5D score points) until 5 years after surgery. The rates for intraoperative and early postoperative complications were 4.4 and 3.2 %, respectively. The overall complication rate during five postoperative years was 23.4 %, and the adjacent segment degeneration rate was 10.7 %. In 4.4 % of patients, a revision surgery was performed. Cumulative survivorship probability for a revision/re-intervention-free 5-year postoperative course was 90.4 %. At the 5-year follow-up, the average range of motion of the mobile segments (86.8 %) was 9.7°. In 43.9 % of patients, osteophytes at least potentially affecting the range of motion were seen. Lumbar TDA appeared as efficient in long-term pain alleviation, consequent reduction of pain medication consumption and improvement of quality of life. The procedure also appeared sufficiently safe, but surgeons have to be aware of a list of potential adverse events. The outcome is stable over the 5-year postoperative period. The vast majority of treated segments remained mobile after 5 years, although almost half of patients showed osteophytes.

Experimental testing on free vibration behaviour for silicone rubbers proposed within lumbar disc prosthesis

This research was focused on the damping capacity study of two types of silicone rubbers proposed as layers within total lumbar disc prostheses of ball-and-socket model. In order to investigate the damping capacity, the two silicone rubber types mainly differing by the molecular mass of polymeric matrix and the filler content, as was emphasized by scanning electron microscopy and differential scanning calorimetry, were subjected to free vibration testing. Using an adapted experimental installation, three kinds of damping testing were realised: tests without samples and tests with three samples of each type of silicone rubber (69 ShA and 99 ShA). The free vibration tests were performed at a frequency of about 6Hz using a weight of 11.8kg. The relative damping coefficient was determined by measuring of two successive amplitudes on the vibrogram and calculating of the logarithmic decrement. The test results with silicone rubber samples showed a relative damping coefficient of 0.058 and respectively 0.077, whilst test results without samples showed a relative damping coefficient of 0.042. These silicone rubbers were found to have acceptable damping properties to be used as layers placed inside the prosthetic components.

Lumbar disc prosthesis and physical and sports activities: A monocentric study with 83 patients

Lumbar disc prosthesis and physical and sports activities: A monocentric study with 83 patients

Clinical outcomes, radiologic kinematics, and effects on sagittal balance of the 6 df LP-ESP lumbar disc prosthesis

Background contextSurgical treatment of degenerative disc disease remains a controversial subject. Lumbar fusion has been associated with a potential risk of segmental junctional disease and sagittal balance misalignment. Motion preservation devices have been developed as an alternative to fusion. The LP-ESP disc is a one-piece deformable device achieving 6 df, including shock absorption and elastic return. This is the first clinical report on its use. PurposeTo assess clinical outcomes and radiologic kinematics in the first 2 years after implantation. Study designProspective cohort of patients with LP-ESP total disc replacement (TDR) at the lumbar spine. Patient sampleForty-six consecutive patients. Outcome measuresClinical outcomes were the visual analog scale (VAS) for pain, the Oswestry disability index (ODI), and the GHQ28 (General Health Questionnaire) psychological score. Radiologic data were the range of motion (ROM), sagittal balance parameters, and mean center of rotation (MCR). MethodsPatients had single-level TDR at L4–L5 or L5–S1. Outcomes were prospectively recorded for 2 years (before and at 3, 6, 12, and 24 months after surgery). The SpineView software was used for computed analysis of the radiographic data. Paired t tests were used for statistical comparisons. ResultsNo intraoperative complication occurred. All clinical scores improved significantly at 24 months: the back pain VAS scores by a mean of 4.1 points and the ODI by 33 points. The average ROM of the instrumented level was 5.4°±4.8° at 2 years and more than 2° for 76% of prostheses. The MCR was in a physiological area in 73% of cases. The sagittal balance (pelvic tilt, sacral slope, and segmental lordosis) did not change significantly at any point of the follow-up. ConclusionsResults from the 2-year follow-up indicate that LP-ESP prosthesis recreates lumbar spine function similar to that of the healthy disc in terms of ROM, quality of movement, effect on sagittal balance, and absence of modification in the kinematics of the upper adjacent level.

Do more MRI findings imply worse disability or more intense low back pain? A cross-sectional study of candidates for lumbar disc prosthesis

To examine whether combined magnetic resonance imaging (MRI) findings are related to the degree of disability and low back pain (LBP) in candidates for lumbar disc prosthesis surgery. This cross-sectional study included 170 disc prosthesis candidates (mean age 41years; 88 women) with chronic non-radicular LBP and localized disc degeneration. Experienced radiologists rated Modic changes and disc findings at L4-S1 on pre-treatment MRIs. An MRI total score (0-10) for findings at L4/L5 plus L5/S1 was calculated for Modic type I and/or II changes, a posterior high intensity zone (HIZ) in the disc, dark/black nucleus pulposus signal, and ≥40% disc height decrease. We analyzed the relationship of the MRI total score to the Oswestry Disability Index (ODI) (n = 170) and LBP intensity scores (0-100 visual analogue scale, n = 165) using multiple linear regression and adjusting for age, gender, body mass index, smoking, and anxiety/depression. The MRI total score was not related to ODI (regression coefficient 0.12, p = 0.79) or LBP intensity (regression coefficient 0.64, p = 0.37). When individual MRI findings were analyzed, patients with HIZ at L5/S1 had slightly lower ODI scores (4.7 points, p = 0.02). In post hoc analyses, results remained unchanged after adding facet arthropathy to the MRI total score and adjusting also for physical workload and physical leisure-time activity. The combined MRI findings were not related to the degree of disability or the intensity of LBP. These degenerative MRI findings cannot explain variation in pre-treatment disability and pain in patients with chronic LBP accepted for disc prosthesis surgery.

Early postoperative dislocation of the anterior Maverick lumbar disc prosthesis

The authors report on 2 cases of anterior dislocation of the Maverick lumbar disc prosthesis, both occurring in the early postoperative period. These cases developed after experience with more than 50 uneventful cases and were therefore thought to be unrelated to the surgeon's learning curve. No similar complications have been previously reported. The anterior Maverick device has a ball-and-socket design made of cobalt-chromium-molybdenum metal plates covered with hydroxyapatite. The superior and inferior endplates have keels to resist translation forces. The patient in Case 1 was a 52-year-old man with severe L4-5 discogenic pain; and in Case 2, a 42-year-old woman with disabling L4-5 and L5-S1 discogenic back pain. Both patients were without medical comorbidities and were nonsmokers with no risk factors for osteoporosis. Both had undergone uneventful retroperitoneal approaches performed by a vascular access surgeon. Computed tomography studies on postoperative Day 2 confirmed excellent prosthesis placement. Initial recoveries were uneventful. Two weeks postoperatively, after stretching (extension or hyperextension) in bed at home, each patient suffered the sudden onset of severe abdominal pain with anterior dislocation of the Maverick prosthesis. The patients were returned to the operating room and underwent surgery performed by the same spinal and vascular surgeons. Removal of the Maverick prosthesis and anterior interbody fusion with a separate cage and plate were performed. Both patients had recovered well with good clinical and radiological recovery at the 6- and 12-month follow-ups. Possible causes of the anterior dislocation of the Maverick prosthesis include the following: 1) surgeon error: In both cases the keel cuts were neat, and early postoperative CT confirmed good placement of the prosthesis; 2) equipment problem: The keel cuts may have been too large because the cutters were worn, which led to an inadequate press fit of the implants; 3) prosthesis fault: Both plates of the dislocated implants looked normal and manufacturer analysis reported no fault; 4) patient factors: Both dislocations happened early in the postoperative period, after hyperextension of the spine while the patient was supine in bed. Bracing would not have reduced hyperextension. Dislocation of a lumbar spinal implant represents a life-threatening complication and should therefore be considered and recognized early. Radiographic and CT studies of both the lumbar spine (for prosthesis) and the abdomen (for hematoma) should be performed, as should CT angiography (for vessel damage or occlusion). Any anterior lumbar revision surgery is hazardous, and it is strongly advisable to have a vascular surgeon scrubbed. In cases of dislocation or extrusion of a lumbar interbody prosthesis, the salvage revision strategy is fusing the segment via the same anterior approach. Surgeons should be aware of the risk of anterior dislocation of the Maverick prosthesis. Keel cutters should be regularly checked for sharpness, as they may be implicated in the loosening of implants. Patients and their physical therapists should also avoid lumbar hyperextension in the early postoperative period.

The LP-ESP® lumbar disc prosthesis with 6 degrees of freedom: development and 7 years of clinical experience

The viscoelastic lumbar disk prosthesis-elastic spine pad (LP-ESP®) is an innovative one-piece deformable but cohesive interbody spacer providing 6 full degrees of freedom about the 3 axes, including shock absorption. A 20-year research program has demonstrated that this concept provides mechanical properties very close to those of a natural disk. Improvements in technology have made it possible to solve the problem of the bond between the elastic component and the titanium endplates and to obtain an excellent biostability. 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, which are 2- or 3-piece devices involving 1 or 2 bearing surfaces and providing 3 or 5 degrees of freedom. This design and the adhesion-molding technology differentiate the LP-ESP prosthesis from other mono-elastomeric prostheses, for which the constraints of shearing during rotations or movement are absorbed at the endplate interface. Seven years after the first implantation, we can document in a solid and detailed fashion the course of clinical outcomes and the radiological postural and kinematic behavior of this prosthesis.

The Use of Percutaneous Lumbar Fixation Screws for Bilateral Pedicle Fractures with an Associated Dislocation of a Lumbar Disc Prosthesis

Study Design. Case report. Objective. To identify a safe technique for salvage surgery following complications of total disc replacement. Summary of Background Data. Lumbar total disc replacement (TDR) is considered by some as the gold standard for discogenic back pain. Revision techniques for TDR and their complications are in their infancy. This case describes a successful method of fixation for this complex presentation. Methods and Results. A 48-year-old male with lumbar degenerative disc disease and no comorbidities. Approximately two weeks postoperatively for a TDR, the patient represented with acute severe back pain and the TDR polyethylene inlay was identified as dislocated anteriorly. Subsequent revision surgery failed immediately as the polyethylene inlay redislocated intraoperatively. Further radiology identified bilateral pedicle fractures, previously unseen on the plain films. The salvage fusion of L5/S1 reutilized the anterior approach with an interbody fusion cage and bone graft. The patient was then turned intraoperatively and redraped. The percutaneous pedicle screws were used to fix L5 to the sacral body via the paracoccygeal corridor. Conclusion. The robust locking screw in the percutaneous screw allowed a complete fixation of the pedicle fractures. At 3-year followup, the patient has an excellent result and has returned to playing golf.

Asymmetric Motion Distribution Between Components of a Mobile-Core Lumbar Disc Prosthesis

The biconvex mobile core of the CHARITÉ lumbar disc prosthesis forms two joints (spherical bearings) with the metal end plates. We quantified the intra-prosthesis motion to test the hypothesis that the total prosthesis motion would not be equally distributed between the two bearings of implanted CHARITÉ discs, which might explain the unequal wear distribution reported in explanted cores. The hypothesis was tested by studying the flexion-extension motion responses of (1) twenty-six monosegmental CHARITÉ III discs implanted in nineteen human cadaveric lumbar spines, and (2) twenty-one CHARITÉ III discs (fifteen monosegmental, six bisegmental) implanted in eighteen patients in other published clinical studies. Intra-prosthesis motions were quantified with use of a radiographic image analysis technique. Eighty-eight percent of the CHARITÉ discs implanted in cadaveric specimens exhibited larger motion at the superior bearing, with 54% demonstrating more than twice as much motion at the superior bearing as at the inferior bearing. The ratio of motion at the superior bearing to motion at the inferior bearing averaged 2.68 ± 1.84, which was significantly larger than 1.0 (p < 0.001). Ninety percent of prostheses implanted in patients showed larger motion at the superior bearing. The motion ratio averaged 2.39 ± 2.47 for monosegmental cases and 2.55 ± 2.66 for all cases; both ratios were significantly larger than 1.0 (p < 0.05). We found preferentially larger motion at the superior bearing of the CHARITÉ discs implanted in human cadaveric lumbar spines and in patients, regardless of the implanted level.

The Effects of Different Articulate Curvature of Artificial Disc on Loading Distribution

Deeper insights into the mechanical behavior of lumbar disc prostheses are required. Prior studies on the biomechanical performance of artificial discs were mostly performed with finite element analyses, but this has never been analyzed with altering articulate curvature. This study aimed to ascertain the influence of the geometry of a ball-and-socket disc prosthesis for the lumbar spine. Three-dimensional finite element model of human L4-L5 was reconstructed. Convex, concave, and elliptic artificial disc models were also established with Computer-Aided-Design software. Simulations included: (1) three articulate types of polyethylene (PE) insert were implanted inferiorly and (2) concave and convex PE inserts were implanted on the superior or inferior sides in flexion/extension, lateral bending, and axial rotation in the lumbar spine. Shear stresses and von Mises stresses on PE insert were assessed for their loading distributions. High shear stresses of all articulate types occurred in flexion, and convex PE insert performed the maximum stress of 23.81 MPa. Under all conditions, stresses on concave PE inserts were distributed more evenly and lower than those on the convex type. Elliptic geometry enabled confining the rotation of the motion unit. The shear force on the convex PE insert on the inferior side could induce transverse crack because the shear stress exceeded yielding shear stress. The concave PE insert on the inferior side not only decreased loading concentration but had relatively low stress. Such a design may be applicable for artificial discs.

Infection and revision strategies in total disc arthroplasty

Our aim was to revise the different strategies for treating an infected disc arthroplasty. Despite recognition that disc replacement may reduce the incidence of adjacent-segment disease, the risk of potential complications associated with primary and revision total disc arthroplasty has diminished surgeon enthusiasm for the procedure. We performed a literature review of the different revision strategies for an infected disc arthroplasty. The need for revision of lumbar total disc arthroplasty has been reported in a number of prospective, randomised trials (level I or II evidence). Suboptimal patient selection and/or surgical technique accounted for the majority of failed disc arthroplasties. Revision procedures include posterior stabilisation or anterior extraction and conversion to arthrodesis. The risk of injury to the great vessels and retroperitoneal structures is greater during revision than primary procedures. The use of a distant lateral, or transpsoas, approach to the anterior column may reduce these adverse events. Also, the use of adhesion barriers has been shown to reduce adhesions in abdominal and pelvic surgery and may be of benefit in revision disc arthroplasty. This review article provides an update on the various treatments for infected lumbar disc prosthesis and the different surgical approaches used in these difficult cases. It also describes potential options to avoid complications associated with the revision surgical approach.

Lumbar Disc Arthroplasty With MAVERICK Disc Versus Stand-Alone Interbody Fusion

Randomized, controlled, multicenter, investigational device exemption trial. To investigate the safety and effectiveness of the first two-piece, metal-on-metal lumbar disc prosthesis for treating patients with single-level degenerative disc disease. For patients with degenerative disc disease unresponsive to conservative measures, lumbar disc arthroplasty provides an alternative to fusion designed to relieve persistent discogenic pain and maintain motion. After 2:1 randomization, 577 patients were treated in either the investigational group (405), receiving lumbar disc arthroplasty, or the control group (172), receiving anterior lumbar interbody fusion. Patients were evaluated preoperatively, at surgery/discharge, and at 1.5, 3, 6, 12, and 24 months after surgery. The primary study endpoint was overall success, a composite measure of safety and effectiveness as recommended by the Food and Drug Administration and defined in the protocol. Both treatment groups demonstrated significant improvements compared with preoperative status. The investigational group had statistically superior outcomes (P < 0.05) at all postoperative evaluations in Oswestry Disability Index, back pain, and Short Form-36 Physical Component Summary scores as well as patient satisfaction. Investigational patients had longer surgical times (P < 0.001) and greater blood loss (P < 0.001) than did control patients; however, hospitalization stays were similar for both groups. Investigational patients had fewer implant or implant/surgical procedure-related adverse events (P < 0.001). Return-to-work intervals were reduced for investigational patients. Disc height and segmental angular motion were maintained throughout the study in the investigational group. In the investigational group, overall success superiority was found when compared to the control group as defined by the Food and Drug Administration Investigational Device Exemption protocol. The investigational group consistently demonstrated statistical superiority versus fusion on key clinical outcomes including improved physical function, reduced pain, and earlier return to work.

Benchmarking Across Spine Registries: Comparison of Pain Alleviation After Lumbar TDA and ALIF with Stratification by Surgeon

The national SWISSspine registry for total disc arthroplasty (TDA) was brought to public attention in 2005 and the possibility of benchmarking between a single lumbar disc prosthesis model against the pooled data of other discs was shown (Aghayev et al. 2010). Comparison of different implants or health care providers can only be performed based on a standardized documentation, which is the case in a national registry.

Reliability of MRI findings in candidates for lumbar disc prosthesis

IntroductionLimited reliability data exist for localised magnetic resonance imaging (MRI) findings relevant to planning of treatment with lumbar disc prosthesis and later outcomes. We assessed the reliability of such findings in chronic low back pain patients who were accepted candidates for disc prosthesis.MethodsOn pretreatment MRI of 170 patients (mean age 41 years; 88 women), three experienced radiologists independently rated Modic changes, disc findings and facet arthropathy at L3/L4, L4/L5 and L5/S1. Two radiologists rerated 126 examinations. For each MRI finding at each disc level, agreement was analysed using the kappa statistic and differences in prevalence across observers using a fixed effects model.ResultsAll findings at L3/L4 and facet arthropathy at L5/S1 had a mean prevalence <10% across observers and were not further analysed, ensuring interpretable kappa values. Overall interobserver agreement was generally moderate or good (kappa 0.40–0.77) at L4–S1 for Modic changes, nucleus pulposus signal, disc height (subjective and measured), posterior high-intensity zone (HIZ) and disc contour, and fair (kappa 0.24) at L4/L5 for facet arthropathy. Posterior HIZ at L5/S1 and severely reduced subjective disc height at L4/L5 differed up to threefold in prevalence between observers (p < 0.0001). Intraobserver agreement was mostly good or very good (kappa 0.60–1.00).ConclusionIn candidates for disc prosthesis, mostly moderate interobserver agreement is expected for localised MRI findings.

Concave polyethylene component improves biomechanical performance in lumbar total disc replacement—Modified compressive-shearing test by finite element analysis

Failure of ultra-high molecular weight polyethylene components after total disc replacements in the lumbar spine has been reported in several retrieval studies, but immediate biomechanical evidence for those mechanical failures remained unclear. Current study aimed to investigate the failure mechanisms of commercial lumbar disc prostheses and to enhance the biomechanical performances of polyethylene components by modifying the articulating surface into a convex geometry. Modified compressive-shearing tests were utilized in finite element analyses for comparing the contact, tensile, and shearing stresses on two commercial disc prostheses and on a concave polyethylene design. The influence of radial clearance on stress distributions and prosthetic stability were considered. The modified compressive-shearing test revealed the possible mechanisms for transverse and radial cracks of polyethylene components, and would be helpful in observing the mechanical risks in the early design stage. Additionally, the concave polyethylene component exhibited lower contact and shearing stresses and more acceptable implant stability when compared with the convex polyethylene design through all radial clearances. Use of a concave polyethylene component in lumbar disc replacements decreased the risk of transverse and radial cracks, and also helped to maintain adequate stability. This design concept should be considered in lumbar disc implant designs in the future.

Influence of the loading frequency on the wear rate of a polyethylene-on-metal lumbar intervertebral disc replacement

Pre-clinical wear testing of intervertebral disc prostheses is commonly carried out according to ISO 18192-1. Ten million multiaxial loading cycles are applied at a frequency of 1 Hz. At this frequency, testing takes about 4 months. Testing at higher frequencies would therefore be desirable. ISO 18192-1 also offers testing at 2 Hz; however, it says the impact on the implant material behaviour as well as on the accuracy of the test machine shall be investigated by the user. Since such data are not available so far, the aim of this study was to carry out comparative wear tests at 1 and 2 Hz. Seven Prodisc-L lumbar disc prostheses were tested. After a pre-soak period, the implants were placed in specimen cups filled with calf serum, mounted to a Spine Wear Simulator and loaded according to ISO 18192-1. Testing was carried out at a temperature of 37 ± 2 °C. Four million loading cycles were applied at 1 Hz and eight million at 2 Hz in an alternating sequence. Each time after 12 days of testing the implants were removed to measure the weight and the height of the polyethylene cores. Then, the test serum was exchanged and the implants were remounted to the testing machine. The mean wear rate was 5.6 ± 2.3 mg per million cycles at 1 Hz and 7.7 ± 1.6 mg per million cycles at 2 Hz during the first six million loading cycles (p < 0.05) and 2.0 ± 0.6 and 4.1 ± 0.7 mg per million cycles during the second six million cycles (p < 0.05). Similarly, the mean heightloss was also smaller at 1 Hz than at 2 Hz (p < 0.05) with -0.02 ± 0.02 mm versus -0.04 ± 0.02 mm per million cycles during the first half of testing and -0.01 ± 0.01 versus -0.02 ± 0.01 mm per million cycles during the second half. The accuracy of the test machine was within the limits described by ISO 18192-1 at both frequencies. The results showed that the wear rate was higher at the beginning than at the end of testing. Also, the results indicated that testing at 2 Hz increases the wear rate compared with 1 Hz in case of a polyethylene-on-metal implant design. In the absence of retrieval studies it is difficult to decide which rate results in a more physiological wear pattern. However, a loading frequency of 1 Hz is probably closer to physiology than 2 Hz since the loading amplitudes prescribed by ISO 18192-1 are high. They rather represent movements like tying shoes or standing up from a chair than walking or sitting. The authors therefore suggest testing at 1 Hz.

Benchmarking in the SWISSspine Registry: results of 52 Dynardi lumbar total disc replacements compared with the data pool of 431 other lumbar disc prostheses

The SWISSspine registry is the first mandatory registry of its kind in the history of Swiss orthopaedics and it follows the principle of "coverage with evidence development". Its goal is the generation of evidence for a decision by the Swiss federal office of health about reimbursement of the concerned technologies and treatments by the basic health insurance of Switzerland. Recently, developed and clinically implemented, the Dynardi total disc arthroplasty (TDA) accounted for 10% of the implanted lumbar TDAs in the registry. We compared the outcomes of patients treated with Dynardi to those of the recipients of the other TDAs in the registry. Between March 2005 and October 2009, 483 patients with single-level TDA were documented in the registry. The 52 patients with a single Dynardi lumbar disc prosthesis implanted by two surgeons (CE and OS) were compared to the 431 patients who received one of the other prostheses. Data were collected in a prospective, observational multicenter mode. Surgery, implant, 3-month, 1-year, and 2-year follow-up forms as well as comorbidity, NASS and EQ-5D questionnaires were collected. For statistical analyses, the Wilcoxon signed-rank test and chi-square test were used. Multivariate regression analyses were also performed. Significant and clinically relevant reduction of low back pain and leg pain as well as improvement in quality of life was seen in both groups (P < 0.001 postop vs. preop). There were no inter-group differences regarding postoperative pain levels, intraoperative and follow-up complications or revision procedures with a new hospitalization. However, significantly more Dynardi patients achieved a minimum clinically relevant low back pain alleviation of 18 VAS points and a quality of life improvement of 0.25 EQ-5D points. The patients with Dynardi prosthesis showed a similar outcome to patients receiving the other TDAs in terms of postoperative low back and leg pain, complications, and revision procedures. A higher likelihood for achieving a minimum clinically relevant improvement of low back pain and quality of life in Dynardi patients was observed. This difference might be due to the large number of surgeons using other TDAs compared to only two surgeons using the Dynardi TDA, with corresponding variations in patient selection, patient-physician interaction and other factors, which cannot be assessed in a registry study.

Einfluss der Position einer lumbalen Bandscheibenprothese auf das segmentale Bewegungsverhalten

Total disc arthroplasty is reported to maintain segmental motion. From finite element studies a rather posterior and central implantation of the prosthesis is recommended. However, there is yet no in vitro study with cadaveric specimens investigating the topic of implant positioning. Ten human lumbar spines were subjected to biomechanical testing. Flexion/extension and side-bending moments were applied from 2.5-7.5 Nm on a spine load simulator. First, the intact specimens were tested in 3 load cycles while motion was monitored with regard to the facet joints under different loads by an ultrasound-based system. An unconstrained total disc prosthesis was then implanted in a central position and the different load cycles were repeated. Finally the implant was positioned in a decentral position with an average offset of 6.2 mm for repetitive data acquisition. Comparison of the facet joint motion in central and eccentric prosthesis positions resulted in the following averaged differences. During flexion of the lumbar spine an average difference of the reference point excursions of 0.38 mm was recorded on the ipsilateral facet joint with reference to the decentral position. For extension, the difference was 0.33 mm on average, for right side bending a difference of 0.63 mm was recorded while left side bending resulted in an average difference of 0.24 mm. The deviation of the reference markers on the contralateral facet joint showed the following average differences: for flexion 0.23 mm and for extension 0.54 mm, respectively. For side bending right/left the differences amounted to 0.18 mm and 0.39 mm. With regard to segmental motion there was no statistically significant difference for both the ipsilateral (p = 0.0564) and the contralateral (p = 0.2593) reference marker. The comparison of the segmental motion after central and decentral implantation of a lumbar total disc prosthesis reveals differences that have, nevertheless, no statistical significance. However, for clinical use it is recommended to strive for a central position of the implant.

P103. Effects of Lumbar Artificial Disc Design on Intervertebral Mobility – In Vivo Comparison Between Mobile-Core and Fixed-Core

BACKGROUND CONTEXT: The main purpose of lumbar disc prosthesis is to preserve physiological segmental motion in order to prevent accelerated degenerative changes at adjacent and implanted levels. However, with respect to motion restoration, effects of disc prosthesis implantation appeared inconsistent. Although in theory the difference of design between fixed-core and mobile-core prosthesis should influence motion restoration, in vivo kinematic differences at the implanted level linked with prosthesis design remained unclear.

Does core mobility of lumbar total disc arthroplasty influence sagittal and frontal intervertebral displacement? Radiologic comparison with fixed-core prosthesis

Background An artificial disc prosthesis is thought to restore segmental motion in the lumbar spine. However, it is reported that disc prosthesis can increase the intervertebral translation (VT). The concept of the mobile-core prosthesis is to mimic the kinematic effects of the migration of the natural nucleus and therefore core mobility should minimize the VT. This study explored the hypothesis that core translation should influence VT and that a mobile core prosthesis may facilitate physiological motion. Methods Vertebral translation (measured with a new method presented here), core translation, range of motion (ROM), and distribution of flexion-extension were measured on flexion-extension, neutral standing, and lateral bending films in 89 patients (63 mobile-core [M]; 33 fixed-core [F]). Results At L4-5 levels the VT with M was lower than with F and similar to the VT of untreated levels. At L5-S1 levels the VT with M was lower than with F but was significantly different compared to untreated levels. At M levels a strong correlation was found between VT and core translation; the VT decreases as the core translation increases. At F levels the VT increases as the ROM increases. No significant difference was found between the ROM of untreated levels and levels implanted with either M or F. Regarding the mobility distribution with M and F we observed a deficit in extension at L5-S1 levels and a similar distribution at L4-5 levels compared to untreated levels. Conclusion The intervertebral mobility was different between M and F. The M at L4-5 levels succeeded to replicate mobility similar to L4-5 untreated levels. The M at L5-S1 succeeded in ROM, but failed regarding VT and mobility distribution. Nevertheless M minimized VT at L5-S1 levels. The F increased VT at both L4-5 and L5-S1. Clinical Relevance This study validates the concept that the core translation of an artificial lumbar disc prosthesis minimizes the VT.