Biomedical subjects

Lutz Claes

Publications and source records attributed to Lutz Claes.

At least 19 recordsLinked to original sources

PubMed2007

Application of a calibration method provides more realistic results for a finite element model of a lumbar spinal segment.

BACKGROUND: An important step in finite element modeling is the process of validation to derive clinical relevant data. It can be assumed that defect states of a finite element model, which have not been validated before, may predict wrong results. The purpose of this study was to show the differences in accuracy between a calibrated and a non-calibrated finite element model of a lumbar spinal segment for different clinical defects. METHODS: For this study, two geometrically identical finite element models were used. An in vitro experiment was designed, deriving data for the calibration. Frequently used material properties were obtained from the literature and transferred into the non-calibrated model. Both models were validated on three clinical defects: bilateral hemifacetectomy, nucleotomy and interspinous defects, whereas in vitro range of motion data served as control points. Predictability and accuracy of the calibrated and non-calibrated finite element model were evaluated and compared. FINDINGS: Both finite element models could mimic the intact situation with a good agreement. In the defects, the calibrated model predicted motion behavior with excellent agreement, whereas the non-calibrated model diverged greatly. INTERPRETATION: Investigating the biomechanical performance of implants and load distribution of different spinal structures by numerical analysis requires not only good agreement with the intact segment, but also with the defect states, which are initiated prior to implant insertion. Because of more realistic results the calibration method may be recommended, however, it is more time consuming.

Finite Element Analysis↗

PubMed2007

Human mesenchymal progenitor cell responses to a novel textured poly(L-lactide) scaffold for ligament tissue engineering.

Biocompatibility and cell seeding capability of a new cell scaffold made of textured polylactic acid (PLA) fibers was investigated as a new material for tissue engineering of anterior cruciate ligaments (ACL). Adhesion and proliferation of human mesenchymal progenitor cells (MPC) was investigated after 15 days by scanning electron microscopy and standard histology. Expression of collagen type I and III, fibronectin, tenascin C, decorin, smooth muscle actin, and the matrix metalloproteinases MMP-1 and MMP-2, as well as their tissue inhibitors TIMP-1 and TIMP-2 was analyzed using real-time PCR. Protein expression of collagen I and III, tenascin C, and proliferating nuclear antigen (PCNA) was determined by immunohistology. Apoptosis was analyzed by detection of p53 expression and TUNEL staining. MPC seeded the scaffold homogeneously and showed good cell growth and no increased rate of apoptosis. After 15 days, the matrix forming genes collagen type I, tenascin C, and decorin were upregulated, indicating the formation of a ligament-like matrix. MMP-1 and TIMP-1 were also significantly increased, suggesting initial matrix remodeling. It was concluded that the new porous PLA scaffold allowed homogeneous cell seeding, a fibroblastic phenotype and the production of a ligament-like matrix and, therefore, might be a suitable cell carrier for ACL tissue engineering.

Apoptosis↗

PubMed2006

Signal transduction pathways involved in mechanotransduction in bone cells.

Several in vivo and in vitro studies with different loading regimens showed that mechanical stimuli have an influence on proliferation and differentiation of bone cells. Prerequisite for this influence is the transduction of mechanical signals into the cell, a phenomenon that is termed mechanotransduction, which is essential for the maintenance of skeletal homeostasis in adults. Mechanoreceptors, such as the integrins, cadherins, and stretch-activated Ca2+ channels, together with various signal transduction pathways, are involved in the mechanotransduction process that ultimately regulates gene expression in the nucleus. Mechanotransduction itself is considered to be regulated by hormones, the extracellular matrix of the osteoblastic cells and the mode of the mechanical stimulus.

Animals↗

PubMed2006

The enhancement of bone regeneration by ultrasound.

Millions of fractures occur every year worldwide, with nearly 6.2 million fractures reported annually in the United States alone. Even though treatment methods have improved over the last few decades, 5-10% of fractures still show delayed healing. A significant subpopulation of these delayed healings do not heal by nine months and are thus termed non-unions. Experimental studies have shown some evidence that low intensity pulsed ultrasound stimulation (LIPUS) results in enhanced bone regeneration during fracture healing and callus distraction. LIPUS treatment has led to increased callus area and accelerated return of bone strength following fracture. Histological studies suggest that LIPUS influences all major cell types involved in bone healing, including osteoblasts, osteoclasts, chondrocytes and mesenchymal stem cells. The affect of LIPUS seems to be limited to cells in soft tissue, whereas cells in calcified bone seem not to be effected. In vitro cell culture studies as well as tissue culture studies have shown some effects on cell differentiation and protein synthesis. Even though the energy used by LIPUS treatment is extremely low, the effects are evident. The most probable source of the therapeutic benefits observed with LIPUS treatment involves nonthermal mechanisms that influence cell membrane permeability and increase cellular activity. Despite clinical and experimental studies demonstrating the enhancing effect of LIPUS on bone regeneration, the biophysical mechanisms involved in the complex fracture healing process remain unclear and requires further research.

Bone Regeneration↗

PubMed2006

Is a collagen scaffold for a tissue engineered nucleus replacement capable of restoring disc height and stability in an animal model?

The idea of a tissue engineered nucleus implant is to seed cells in a three-dimensional collagen matrix. This matrix may serve as a scaffold for a tissue engineered nucleus implant. The aim of this study was to investigate whether implantation of the collagen matrix into a spinal segment after nucleotomy is able to restore disc height and flexibility. The implant basically consists of condensed collagen type-I matrix. For clinical use, this matrix will be used for reinforcing and supporting the culturing of nucleus cells. In experiments, matrixes were concentrated with barium sulfate for X-ray purposes and cell seeding was disclaimed in order to evaluate the biomechanical performance of the collagen material. Six bovine lumbar functional spinal units, aging between 5 and 6 months, were used for the biomechanical in-vitro test. In each specimen, an oblique incision was performed, the nucleus was removed and replaced by a collagen-type-I matrix. Specimens were mounted in a custom-built spine tester, and subsequently exposed to pure moments of 7.5 Nm to move within the three anatomical planes. Each tested stage (intact, nucleotomy and implanted) was evaluated for range of motion, neutral zone and change in disc height. Removal of the nucleus significantly reduced disc height by 0.84 mm in respect to the intact stage and caused an instability in the segment. Through the implantation of the tissue engineered nucleus it was possible to restore this height and stability loss, and even to increase slightly the disc height of 0.07 mm compared with the intact stage. There was no statistical difference between the stability provided by the implant and intact stage. Results of movements in lateral bending and axial rotation showed the same trend compared to flexion/extension. However, implant extrusions have been observed in three of six cases during the flexibility assessment. The results of this study directly reflect the efficacy of vital nucleus replacement to restore disc height and to provide stability to intervertebral discs. However, from a biomechanical point of view, the challenge is to employ an appropriate annulus fibrosus sealing method, which is capable to keep the nucleus implant in place over a long-time period. Securing the nucleus implant inside the disc is one of the most important biomechanical prerequisites if such a tissue engineered implant shall have a chance for clinical application.

Absorbable Implants↗

PubMed2006

Effects of diclofenac on periosteal callus maturation in osteotomy healing in an animal model.

INTRODUCTION: Potential adverse effects of nonsteroidal anti-inflammatory drugs (NSAIDs) on bone metabolism and fracture healing are contradictive to their wide application in post-traumatic treatment. Our objective was to investigate changes to periosteal callus formation with respect to NSAID and central analgesic drug application. Our hypothesis was that callus formation is delayed in animals treated with the non-specific NSAID diclofenac. MATERIALS AND METHODS: The left tibia of forty male Wistar rats were osteotomized, stabilized with a Kirschner wire, and randomized into four groups of ten animals. Group 1 received a placebo, group 2 received the central analgesic tramadol (20 mg/kg per day) throughout the study, and groups 3 and 4 were treated with sodium diclofenac (5 mg/kg per day). Group 3 received diclofenac for seven days, followed by placebo until sacrifice (short-term), while group 4 animals received diclofenac for the full period (long-term). Animals were sacrificed 21 days after osteotomy. RESULTS: Under light microscopy, all osteotomies healed successfully and independently of the drug treatment. Histomorphometry revealed delayed callus maturation in long-term diclofenac treated animals, with significantly higher amounts of cartilage and less bone, particularly in the outermost region of periosteal callus. Short-term NSAID and tramadol application did not significantly alter callus differentiation. CONCLUSION: Callus maturation in vivo was impaired after long-term application of diclofenac which corresponds to the in vitro findings of a dose-dependent effect of NSAIDs on osteoblast proliferation.

Administration, Oral↗

PubMed2006

Stepwise reduction of functional spinal structures increase vertebral translation and intradiscal pressure.

To date, there are only a few studies that provide data to efficiently calibrate finite element models for the spine due to its complexity. In a recent study, we quantified the range of motion rotation and the lordosis angle. This paper provides complementary results regarding two more parameters, intradiscal pressure and vertebral translation. All parameters were obtained as a function of stepwise anatomical reduction, loading direction and magnitude. Eight lumbar spinal segments (L4-5) with a median age of 52 years (38-59 years) and no signs of disc degeneration were used for the in vitro testing. A miniaturized pressure probe was implanted into the nucleus. An ultrasound-based motion-tracking system was employed to record spatial movements of several landmarks on the specimens. The center of L4, the anterior, posterior, left and right point of the lower endplate of L4 were digitized as landmarks and its translation was determined. Specimens were loaded with pure moments (1-10Nm) in the three principal anatomical planes at a loading rate of 1.0 degrees /s. Anatomy was stepwise reduced by cutting different ligaments, facet capsules and joints and removing nucleus. Translation analysis showed that the L4 center point had its largest displacement in sagittal direction and almost none vertically. Removal of the supra- and interspinous, flaval ligaments showed a slight increase and further removal of structures, a higher increase of translation. Axial rotation also was accompanied with L4 to elevate when torsion was applied. This effect was found to be larger with progressing defects. Nucleotomy exhibited the most unstable situation for specimens. Results of the intradiscal pressure indicated a large increase after removing the facet capsules and joints. Furthermore, it was found that intradiscal pressure correlated well with data of range of motion for rotation. Predicting and simulating clinical defects, surgical intervention or treatment methods requires a well performed calibration based on in vitro data, whereas it is important to adapt all including structures with as many known parameters as possible. Results provided by these studies may be used as a database for researchers aiming to calibrate or validate finite element models of L4-5 segments.

Adult↗

PubMed2006

Validity and interobserver agreement of a new radiographic grading system for intervertebral disc degeneration: Part II. Cervical spine.

A new radiographic grading system for a more objective assessment of lumbar intervertebral disc degeneration has been described and tested in Part I of this study. The aim of the present Part II of the study was to adapt this system to the cervical spine, and to test it for validity and interobserver agreement. Some modifications of the grading system described in Part I were necessary to make it applicable to the cervical spine. Its basic structure, however, stayed untouched. The three variables "Height Loss", "Osteophyte Formation" and "Diffuse Sclerosis" first have to be graded individually. Then, the "Overall Degree of Degeneration" is assigned on a four-point scale from 0 (no degeneration) to 3 (severe degeneration). For validation, the radiographic degrees of degeneration of 28 cervical discs were compared to the respective macroscopic ones, which were defined as "real" degrees of degeneration. The interobserver agreement was determined between one experienced and one unexperienced observer using the radiographs of 57 cervical discs. Quadratic weighted Kappa coefficients (kappa) with 95% confidence limits (95% CL) were used for statistical evaluation. The validation of the new version of the radiographic grading system showed a moderate agreement with the "real", macroscopic overall degree of degeneration (kappa=0.599, 95% CL 0.421-0.786). In 64% of all discs the "real" overall degree of degeneration was underestimated but never overestimated. This underestimation, however, was much less pronounced and the Kappa coefficients were significantly higher for the three variables: Height Loss, Osteophyte Formation, and Diffuse Sclerosis separately. The agreement between the radiographic ratings of the experienced and the unexperienced observer was substantial for the overall degree of degeneration (kappa=0.688, 95% CL 0.580-0.796), almost perfect for the variable, Height Loss, moderate for Osteophyte Formation and fair for Diffuse Sclerosis. In conclusion, we believe that the new version of the radiographic grading system is a sufficiently valid and reliable tool to quantify the degree of degeneration of individual cervical intervertebral discs. In comparison to the version for the lumbar spine described in Part I, however, a slightly higher tendency to underestimate the "real" overall degree of degeneration and somewhat higher interobserver differences have to be expected.

Aged↗

PubMed2006

Stepwise reduction of functional spinal structures increase range of motion and change lordosis angle.

Many investigators have performed studies on specific defect situations or determined the contribution on isolated structures. Investigating the contribution of functional structures requires obtaining the kinematic response directly on spinal segments. The purpose of this study was to quantify the function of anatomical components on lumbar segments for different loading magnitudes. Eight spinal segments (L4-5) with a median age of 52 years (ranging from 38 to 59 years) and a low degree of disc degeneration were utilized for the in vitro testing. Specimens were mounted in a custom-built spine tester and loaded with pure moments (1-10 N m) to move within three anatomical planes at a loading rate of 1.0 degrees /s. Anatomy was successively reduced by: ligaments, facet capsules, joints and nucleus. Data were evaluated for range of motion, neutral zone and lordosis angle. Transection of posterior ligaments predominantly increased specimen flexion for all bending moments applied. Supraspinous ligament also indicated to resist in extension slightly, whereas the facet capsules did not. Facet joints contributed to axial rotation, but not in lateral bending. The anterior longitudinal ligament was found to slightly resist in axial rotation, but strongly in extension. Nucleotomy caused largest increase of all movements. The unloaded posture of the specimens changed after ligament dissection, indicating ligament pretension. The region of lumbar spine is interesting for finite element (FE) simulation due to the high evidence of disc degeneration and injuries. This study may help to understand the function of specific anatomical structures and assists in FE model calibration. We suggest to start a calibration procedure for such models with the smallest functional structure (annulus) and to cumulatively add further structures.

Adult↗

PubMed2006

Signal transduction pathways involved in mechanical regulation of HB-GAM expression in osteoblastic cells.

Protein kinase C (PKC), protein kinase A (PKA), prostaglandin synthesis, and various mitogen-activated protein kinases (MAPKs) have been reported to be activated in bone cells by mechanical loading. We studied the involvement of these signal transduction pathways in the downregulation of HB-GAM expression in osteoblastic cells after cyclic stretching. Specific antagonists and agonists of these signal transduction pathways were added to cells before loading and to non-loaded control cells. Quantitative RT-PCR was used to evaluate gene expression. The data demonstrated that the extracellular signal-regulated kinase (ERK) 1/2 pathway, PKC, PKA, p38, and c-Jun N-terminal kinase MAPK participated in the mechanical downregulation of HB-GAM expression, whereas prostaglandin synthesis did not seem to be involved.

Carrier Proteins↗

PubMed2006

Application of a new calibration method for a three-dimensional finite element model of a human lumbar annulus fibrosus.

BACKGROUND: Major deficits of many finite element models of the lumbar spine are the oversimplification, assumed constellation of the material properties or the insufficiently performed calibration using experimental in vitro data. The aim of this study was, to develop a method for calibrating the two-composite structure of the annulus fibrosus, the ground substance and collagen fibers. METHODS: For that purpose, a three-dimensional, non-linear finite element model of a denucleated intervertebral disc with the adjacent vertebral bodies (L4-L5) was created. Previously performed in vitro experiments provided experimental data for the range of motion in each load direction, needed for calibration. A method was developed to determine the individual contribution of the fibers and the ground substance for bending moments with four different magnitudes (2.5, 5.0, 7.5 and 10 Nm). For each bending moment, the stiffness of fibers was varied to approximate the Young's modulus of the ground substance in order to fulfil the required range of motion obtained from in vitro results within an accuracy of 99%. RESULTS: Infinite material parameter combinations of collagen fibers and ground substance led to the same range of motion, which were different for each bending moment. However, there was only one combination, which was valid for all applied bending moments; and in all load direction. INTERPRETATION: This calibration method was performed on range of motion data; however, the procedure could also be applied to other loading scenarios and measurement parameters like disc bulge, translation and intradiscal pressure.

Calibration↗

PubMed2006

Biological response to a new composite polymer augmentation device used for cruciate ligament reconstruction.

A resorbable composite augmentation cord braided of poly(L-lactide) and poly(L-lactide-co-glycolide) fibers was designed for the temporary protection of repaired cruciate ligaments. This study examined the biocompatibility of the new device and the influence of augmentation duration on ligament healing in a sheep model. The anterior cruciate ligament (ACL) was cut close to the femoral insertion and reinserted with sutures. The repaired ACLs were augmented with the slowly degrading new composite cord and alternatively with a faster degrading polydioxanone cord (PDS). A tendon graft group (gold standard) served as control. Histological evaluation and biomechanical testing were performed after 6 months. The composite cord showed no signs of degradation, whereas the PDS was intra-articularly resorbed. Both devices showed only minor foreign body reactions, proving their good biocompatibility. However, 9 of 11 composite cords had ruptured too early because of fatigue at the bone tunnel entrances. All operated knees were less stable than the nonoperated collateral joints. Knees equipped with the composite cord showed the largest anterior instabilities, whereas the PDS-augmented group exhibited in some cases knee instabilities comparable with that of the tendon group. A positive effect of a longer mechanical protection by a slowly degrading augmentation could not yet be shown. The fatigue strength of the device still needs improvement.

Animals↗

PubMed2006

Moderate soft tissue trauma delays new bone formation only in the early phase of fracture healing.

The aim of this study was to investigate the effect of a moderate soft tissue trauma to the course of fracture healing in a standardized animal model. Thirty-eight Wistar rats were randomly divided into a fracture group (F, n = 19) and a group with a fracture and a soft tissue trauma (F + STT, n = 19). The fracture and the soft tissue trauma were created using an impact device with a standardized energy. All fractures were stabilized by two Kirschner wires. Three rats were measured for blood flow and sacrificed at days 1, 3, 7, and 14, and seven rats at day 28, from both groups. A three-point bending test was performed on the healed tibia after 28 days. During the first 24 h there was a reduction in blood flow, which was more pronounced in the F + STT group than in the F group. From histological sections, the shape of the callus formation, as well as the tissue distribution of newly formed bone, fibrous cartilage and fibrous connective tissue were determined. Distinctly more periosteal new bone formed and a larger callus formed at days 3 and 7 in group F compared to group F + STT. However, by days 14 and 28, the ossification and overall callus size no longer showed differences between the two groups. A fast recovery of blood flow and callus formation took place in the F + STT group, which led to similar histological and biomechanical results in fracture healing observed after 28 days between the two groups.

Animals↗

PubMed2006

Influence of the crash pulse shape on the peak loading and the injury tolerance levels of the neck in in vitro low-speed side-collisions.

The aim of the present in vitro study was to investigate the effect of the crash pulse shape on the peak loading and the injury tolerance levels of the human neck. In a custom-made acceleration apparatus 12 human cadaveric cervical spine specimens, equipped with a dummy head, were subjected to a series of incremental side accelerations. While the duration of the acceleration pulse of the sled was kept constant at 120 ms, its shape was varied: Six specimens were loaded with a slowly increasing pulse, i.e. a low loading rate, the other six specimens with a fast increasing pulse, i.e. a high loading rate. The loading of the neck was quantified in terms of the peak linear and angular acceleration of the head, the peak shear force and bending moment of the lower neck and the peak translation between head and sled. The shape of the acceleration curve of the sled only seemed to influence the peak translation between head and sled but none of the other four parameters. The neck injury tolerance level for the angular acceleration of the head and for the bending moment of the lower neck was almost identical for both, the high and the low loading rate. In contrast, the injury tolerance level for the linear acceleration of the head and for the shear force of the lower neck was slightly higher for the low loading rate as compared to the high loading rate. For the translation between head and sled this difference was even statistically significant. Thus, if the shape of the crash pulse is not known, solely the peak bending moment of the lower neck and the peak angular acceleration of the head seem to be suitable predictors for the neck injury risk but not the peak shear force of the lower neck, the peak linear acceleration of the head and the translation between head and thorax.

Acceleration↗

PubMed2006

[Study of the toxicity of povidone-lodine for fibroblast-like cells (BALB-3T3) and primary human chondrocytes].

Povidone-iodine (polyvinyl-pyrrolidone-iodine complex, PVP-iodine, CAS 25655-41-8) is a commonly used antiseptic because of its broad spectrum of antimicrobial effect and its comparatively low allergic risk. It is also used for open joint lavage. Animal and organ culture studies provide controversial results about the risk of cartilage damage due to povidone-iodine. There is a paucity of in vitro study data concerning the effect of povidone-iodine on chondrocyte cultures are still missing. The aim of this study was therefore to investigate the effect of different concentrations and exposition times of povidone-iodine on cell growth and differentiation of human chondrocytes. Using of a vitality test (MTT) and a proliferation assay (BrdU) in the fibroblast-like cell line BALB3T3, suitable concentrations and incubation times were identified to investigate the influence of povidone-iodine on proteoglycan synthesis and DNA synthesis of primary human chondrocytes. Concentrations of up to 1% povidone-iodine had no significant effect on proteoglycan and DNA synthesis of chondrocytes after incubation for 30 min. An incubation time of 24 h did not inhibit DNA- and proteoglycan synthesis, until a concentration of 0.2% povidone-iodine was used. DNA synthesis rate was impaired after 10 min incubation with 0.2% and fully inhibited with 1% povidone iodine. BALB3T3 reacted more sensitively than chondrocytes. Vitality and proliferation rate were fully inhibited at a concentration of 0.5% after the same exposition time. However, cells recovered 24 h after 30 min incubation with 0.5% povidone-iodine. After incubation with 5% povidone iodine cells did not recover. From the results it can be concluded that low concentrations of povidone-iodine (< 1%) and short incubation times (< 30 min) have no damaging influence on chondrocytes. Previous studies have reported the antimicrobial effectiveness of low concentrations of povidone-iodine on the reduction of tissue damage by microorganisms. Data from previus studies and the current findings from this investigation support the clinical use of povidone-iodine at low concentrations and short incubation times for antiseptic treatment of cartilage tissues.

3T3 Cells↗

PubMed2006

Therapeutic cooling: no effect on hamstring reflexes and knee stability.

PURPOSE: Stretch reflexes contribute to joint stiffness, but the effects of therapeutic cooling on these reflexes are unknown. Therapeutic cooling is frequently used in knee rehabilitation, for instance, after rupture of the anterior cruciate ligament. Cooling a joint can affect nerve conduction velocity and the function of sensory organs. Such changes in neuromuscular coupling could reduce knee stability and increase the risk of knee injury. The aim of the present study was to evaluate whether there are negative effects of knee cooling on the hamstring short and medium latency reflex responses or on the anterior tibia trajectory after mechanically induced tibia translation. METHODS: In 15 healthy volunteers, the latency and size of short latency and medium latency reflex responses of hamstring muscles were assessed before and after 20 min of cold therapy of the knee joint as applied in rehabilitation. Reflex responses were evoked by a mechanically induced posterior-anterior tibia translation during standing. Reflexes were recorded by surface electromyography. The distance of anterior tibia motion and its velocity were assessed by potentiometric position transducer. RESULTS: Local cold therapy of the knee did not alter the latency or the size of short or medium latency responses. Also, the extent and the velocity of tibia translation were unchanged after knee cooling. CONCLUSION: Cold therapy does not seem to adversely influence the spinal reflexes of the hamstrings induced by anterior tibia translation. As neuromuscular coupling was not significantly affected, the cold therapy, as performed in the present study, is not likely to increase the risk of knee injury.

Adult↗

PubMed2005

Bone formation in a long bone defect model using a platelet-rich plasma-loaded collagen scaffold.

Platelet-rich plasma (PRP), a platelet concentrate made of autogenous blood, has been used in recent years to improve bone defect healing particularly in maxillofacial reconstructions. The aim of the present study was to assess the effect of PRP on new bone formation in a critical diaphyseal long bone defect. A critical size defect (2.5 cm) in the tibial diaphysis of 16 sheep was supplied either with autogenous PRP in a collagen carrier or with collagen alone (controls). Platelets were enriched about 3.5 fold compared to normal blood in the PRP. After 12 weeks, the explanted bone specimens were quantitatively assessed by X-ray, computed tomography (CT), biomechanical testing and histological evaluation. Bone volume, mineral density, mechanical rigidity and histology of the newly formed bone in the defect did not differ significantly between the PRP treated and the control group, and no effect of PRP upon bone formation was observed. It was suggested that PRP does not enhance new bone formation in a critical size defect with a low regenerative potential. Such bone defects might require more potent stimuli, e.g. combinations of functional biomaterials or autografts, precursor cells or osteoinductive growth factors.

Animals↗

PubMed2005

Validity and interobserver agreement of a new radiographic grading system for intervertebral disc degeneration: Part I. Lumbar spine.

Many different radiographic grading systems for disc degeneration are described in literature. However, only a few of them are tested for interobserver agreement and none for validity. Furthermore, most of them are based on a subjective terminology. The aim of this study, therefore, is to combine these systems to a new one in which all subjective terms are replaced by more objective ones and to test this new system for validity and interobserver agreement. Since lumbar and cervical discs need to be graded differently, this study was divided into the present Part I for the lumbar and a Part II for the cervical spine. The new radiographic grading system covers the three variables "Height Loss", "Osteophyte Formation" and "Diffuse Sclerosis". On lateral and postero-anterior radiographs, each of these three variables first has to be graded individually. Then, the "Overall Degree of Degeneration" is assigned on a four-point scale from 0 (no degeneration) to 3 (severe degeneration). For validation, the radiographic degrees of degeneration of 44 lumbar discs were compared to the respective macroscopic ones, which were defined as "real" degrees of degeneration. The agreement between observers with different levels of experience was determined using the radiographs of 84 lumbar discs. Agreement was quantified using quadratic weighted Kappa coefficients (Kappa) with 95% confidence limits (95% CL). The validation of the new radiographic grading system revealed a substantial agreement between the radiographic and the "real" macroscopic overall degree of degeneration (Kappa=0.714, 95% CL: 0.587-0.841). The radiographic grades, however, tended to be slightly lower than the "real" ones. The interobserver agreement was substantial for all the three variables and for the overall degree of degeneration (Kappa=0.787, 95% CL: 0.702-0.872). However, the inexperienced observer tended to assign slightly lower degrees of degeneration than the experienced one. In conclusion, we believe that the new radiographic grading system is an almost objective, valid and reliable tool to quantify the degree of degeneration of individual lumbar intervertebral discs. However, the user should always remember that the "real" degree of degeneration tends to be underestimated and that slight differences between the ratings of observers with different levels of experience have to be expected.

Adult↗