Objectives. Degenerative disc disease (DDD) and osteoarthritis (OA) are relatively frequent causes of disability amongst the elderly; they constitute serious socioeconomic costs and significantly impair quality of life. Previous studies to date have found that aggrecan variable number of tandem repeats (VNTR) contributes both to DDD and OA. However, current data are not consistent across studies. The purpose of this study was to evaluate systematically the relationship between aggrecan VNTR, and DDD and/or OA. Methods. This study used a highly sensitive search strategy to identify all published studies related to the relationship between aggrecan VNTR and both DDD and OA in multiple databases from January 1996 to December 2016. All identified studies were systematically evaluated using specific inclusion and exclusion criteria. Cochrane methodology was also applied to the results of this study. Results. The final selection of seven studies was comprehensively evaluated and includes results for 2928 alleles. The most frequent allele among all the studies was allele 27. After comparing the distributions of each allele with others, statistically significant differences have been found in the distribution of the alleles by the two groups, with an over-representation of allele (A)21 (disease: 3.22%, control: 0.44%). Thus, carrying A21 increased the risk of DDD. Such an association was not found to be statistically significant when considering the risk of OA. Conclusions. The findings suggest that VNTR A21 seems to be associated with higher risk to DDD, however, such an association may not be statistically significant regarding the risk of OA. Cite this article: L. Cong, G. Tu, D. Liang. A systematic review of the relationship between the distributions of aggrecan gene VNTR polymorphism and degenerative disc disease/osteoarthritis. Bone Joint Res 2018;7:308–317. DOI: 10.1302/2046-3758.74.BJR-2017-0207.R1

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

Introduction. Degenerative disc disease results from mechanical alteration of the intervertebral disc. Biochemical modifications of the nucleus matrix are also incriminated. Furthermore, genetic predispositions as well as vascular factors have been advocated in the process of disc degeneration. A relationship between sciatica and Propionibacterium acnes has been described. However, it remains unclear if the hypothesis of a subclinical spondylodiscitis might play a role in the pathophysiology of degenerative disc disease. The purpose of this study was to analyze the possible presence of bacteria in lumbar discs of patients with degenerative disc disease. Methods. We prospectively analyzed the presence of bacteria in 83 patients (34 males and 49 females, average age 41 years) treated by lumbar disc replacement at L3-L4, L4-L5 or L5-S1. An intraoperative biopsy and microbiological culture were performed for each disc to determine if intradiscal bacteria were present. Great care was taken to avoid any source of contamination during the conditioning process of the biopsy. Microbiological results were compared to the magnetic resonance stages of disc degeneration according to the Pfirrmann and Modic classifications. Possible sources of previous iatrogenic disc contamination after discography or nucleotomy were analyzed. Results. The magnetic resonance stages were Pfirrmann IV or V, with Modic I signs in 32 and Modic II in 25 cases. A preoperative discography was performed in 49 patients, and 24 had previous nucleotomy. Germs were found in 40 discs, 43 cultures were steriles. The following bacteria were evidenced: Propionibacterium acnes 18, Staphylococcus coagulase negative 16, Staphylococcus aureus 3, Gram negative bacilli 3, Micrococcus 3, Corynebacterium 3, others 5. Ten biopsies presented several different germs. Bacteria were predominantly found in males (p=0.012). The mostly positive level was L4-L5 (p=0.075). Histological examination of 31 discs found inflammatory cells in 33 % of the biopsies with positive bacterial culture, versus 5 % of the sterile biopsies (p=0.038). There was no significant relationship between bacterial evidence and Modic sign. A preoperative discography or previous nucleotomies did not represent significant contamination sources. None of the patients presented clinical signs of infection. Conclusions. The finding of bacteria in 48 % of disc biopsies, presence of inflammatory cells at histological examination, the absence of responsibility of the discography as a factor of contamination, and the absence of clinical post-operative infection, defend the hypothesis of a low-grade spondylodiscitis which might play a role in the pathophysiology of degenerative disc disease. On the other hand, the presence of skin commensal bacteria, of ¼ of polymicrobial biopsies, and the fact that previous nucleotomy doesn't seem to be involved in inoculation, cannot allow to eliminate a contamination of the samples. Further studies are necessary to elucidate the responsability of intradiscal bacteria in degenerative disc disease. This could influence our treatment strategy of back pain, which could be based in the future on antibiotics

Background: It is very difficult to ascertain how much of the degeneration seen in a post-traumatic spine was due to pre-existing disease and how much was due to the trauma. The aim of the current study was to determine the prevalence of pre-existing disc degeneration on MRI in a region of the spine injured by spinal trauma. Methods: Prospective whole spine MRI study in 118 patients with spinal trauma. One hundred and eighteen consecutive patients (79M:39F, mean age 36years, range 13 – 90 yrs) admitted to our spinal unit for treatment of their acute spinal trauma were investigated with whole spine magnetic resonance imaging (MRI). Whole spine MRI was already the standard protocol for all patients admitted with spinal trauma to rule out co-existing pathology and multiple spinal fractures. 1. Patient data, including age, sex, and mechanism of injury was recorded prospectively onto a spinal injury database. We divided the spine into cervical (C1–C7), thoracic (T1–T12), and lumbosacral (L1–S1) regions. For the purpose of this study we documented the presence or absence of pre-existing degenerative disc disease in all regions of the spine. Of particular interest was any pre-existing degenerative disc disease in the region affected by the spinal trauma. The number of spinal levels affected by pre-existing disc disease within each region was also detailed. Results: The two most common mechanisms of injury were flexion-compression (68 patients) and flexion-distraction (24 patients). Seventy-one of the patients sustained burst fractures and the vast majority of these were in the thoracolumbar region. Thirty-seven patients (31%) had degenerative disc disease in the same region of the spine that was injured in the spinal trauma. Seven patients had pre-existing cervical degeneration in the presence of cervical spine trauma and thirty had pre-existing lumbosacral degeneration in patients that had lumbosacral trauma. Twenty four patients (20%) had more than one level of degenerative change within the same region as their spinal trauma. Eighteen patients (15%) had degeneration in a different region of the spine to the one that was injured. Conclusion: Thirty one percent of the patients in our study had pre-existing degenerative disc disease in the same region as their spinal trauma despite the average age of our patients being only 36yrs. This has important medicolegal implications because it means that a large % of patients who sustain spinal trauma have pre-existing degenerative changes which are not the result of their injury

We have measured the dynamic movement of the lumbar spine in 57 patients with degenerative lumbar disc disease. Each completed a questionnaire which recorded pain and subjective signs and symptoms. From plain lateral radiographs, the subjects were graded using the criteria of Kellgren and Lawrence and those of Lane et al, which are both based on the severity of degenerative changes. Measurements of the height of the disc space and the vertebral height were obtained and expressed as a ratio. We found no relationship between the characteristics of spinal movement and the overall grading of degenerative disc disease with either system. Both were influenced (p < 0.01) by age, walking distance, severity of symptoms, drug intake and frequency of pain. The present systems for grading degenerative disc disease from plain lateral radiographs have limited application

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. Results. The number of patients with additional surgery were 32/183 (17%) in the PLF group, 229/1256 (18%) in the IPLF group, and 439/1435 (31%) in the IBF group. With the PLF group as a reference, the hazard ratio for additional lumbar surgery was 1.16 (95% confidence interval (CI) 0.78 to 1.72) for the IPLF group and 2.13 (95% CI 1.45 to 3.12) for the IBF group. All patient-reported outcomes improved after surgery (p < 0.001) but were without statistically significant differences between the groups at the one-, two- and 6.9-year follow-ups (all p ≥ 0.12). Conclusion. The addition of interbody fusion to posterolateral fusion was associated with a higher risk for additional surgery and showed no advantages in patient-reported outcome. Cite this article: Bone Joint J 2019;101-B:1526–1533

The World Health Organisation (WHO) has included low back pain in its list of twelve priority diseases. Notably, Degenerative disc disease (DDD) presents a large, unmet medical need which results in a disabling loss of mechanical function. Today, no efficient therapy is available. Chronic cases often receive surgery, which may lead to biomechanical problems and accelerated degeneration of adjacent segments. Our consortium partners have developed and studied mesenchymal stem cell-based, regenerative therapies trials. In previous phase 2 trial, patients exhibited rapid and progressive improvement of functional and pain indexes after 1 year with no significant side effects. To develop the world's first rigorously proven, effective treatment of DDD, EUROSPINE aims to assess, via a multicentre, randomized, controlled, phase 2b clinical trial including 112 patients with DDD, the efficacy of an allogenic intervertebral mesenchymal stem cell (MSC)-based therapy. This innovative therapy aims to rapidly and sustainably (at least 24 months) reduce pain and disability. In addition, the consortium aims to provide new knowledge on immune response & safety associated with allogeneic BM-MSC intradiscal injection. This simple procedure would be cost-effective, minimally invasive, and standardised. At the end of the RESPINE trial, we aim to propose a broadly available and clinically applicable treatment for DDD, marketed by European SMEs

We obtained intervertebral discs with cartilage endplates and underlying cancellous bone at operation from patients with degenerative disc disease and then used immunohistochemical techniques to localise the nerves and nerve endings in the specimens. We used antibodies for the ubiquitous neuronal protein gene product 9.5 (PGP 9.5). Immunoreactivity to neuropeptide Y was used to identify autonomic nerves and calcitonin gene-related peptide (CGRP) and substance P to identify sensory nerves. Blood vessels were identified by immunoreactivity with platelet-endothelial cell-adhesion molecule (CD31; PECAM). In a control group with no known history of chronic back pain, nerve fibres immunoreactive to PGP 9.5 and neuropeptide Y were most closely related to blood vessels, with occasional substance P and CGRP immunoreactivity. In patients with severe back pain and markedly reduced disc height, proliferation of blood vessels and accompanying nerve fibres was observed in the endplate region and underlying vertebral bodies. Many of these nerves were immunoreactive to substance P or CGRP, and in addition, substance P- and CGRP-immunoreactive nociceptors were seen unrelated to blood vessels. Quantification by image analysis showed a marked increase in CGRP-containing sensory nerve fibres compared with normal control subjects. We speculate that a chemotactic response to products of disc breakdown is responsible for the proliferation of vascularity and CGRP-containing sensory nerves found in the endplate region and vertebral body adjacent to degenerate discs. The neuropeptides substance P and CGRP have potent vasodilatory as well as pain-transmitting effects. The increase in sensory nerve endings suggests increase in blood flow, perhaps as an attempt to augment the nutrition of the degenerate disc. The increase in the density of sensory nerves, and the presence of endplate cartilage defects, strongly suggest that the endplates and vertebral bodies are sources of pain; this may explain the severe pain on movement experienced by some patients with degenerative disc disease

Introduction. Epidural steroid injection is an established treatment modality for intervertebral disc prolapse. It is a low-risk alternative to surgical intervention in some patients for whom noninvasive treatment has failed. Caudal epidural steroid injection is one of the most widely used methods for pain relief. The aim of this study was to determine the significance of same dose in different volume of caudal epidural steroid injection in the treatment of lumbar degenerative disc disease. Material/Methods. Prospective study was conducted during 2007 to 2009. 100 Patients were randomized in to two groups, of which 50 % (group A) received 4 ml of steroid with isotonic saline and remaining 50 % (group B) received 12 ml. Injection was given in prone position through a 22-G needle in to the epidural space through the sacral hiatus. The average follow-up was 18 months. Outcomes scores included the SF-36, Oswestry disability index and pain VAS and were recorded in the pre and post injection periods. Results. In group A, 18 patients had significant pain relief and 32 had no relief during the early period. Whereas in group B, 22 had significant pain relief and 28 had no relief. The quality of pain relief of 50% or greater was considered as significant. Follow up after 1 year does not show much difference. Group B had significant decrease in symptoms in the initial post injection period (P<0.05). Conclusions. The volume of steroid solution in the treatment of lumbar degenerative disc disease is significant in the early post injection period only

Introduction: In comparison to anterior cervical decompression and fusion (ACDF), cervical disc arthroplasty has the potential of maintaining normal segmental lordosis, anatomical disc space height, and physiological motion patterns that may reduce or delay the onset of degenerative disc disease at adjacent cervical spinal motion segments. Aim: The objective of this study was to determine patient satisfaction post cervical disc arthroplasty. by evaluating each patient both clinically and radiologically. Materials and Methods: A retrospective study was performed on all patients with symptomatic cervical radiculopathy and/or myelopathy who had undergone cervical disc arthroplasty by a single surgeon after a standard anterior cervical discectomy. Outcome measures included the Short Form-36 (SF-36) and Neck Disability Index (NDI) questionnaires, neurological status, and radiographic status. Results: Over a 32 month period, 15 patients underwent cervical disc arthroplasty, with 12 patients undergoing single level arthroplasty. 2 patients undergoing 2 level arthroplasty and one patient undergoing a 3 level arthroplasty. The C5/C6 level was involved in 9 cases (60%). The male female ratio was 7:8. The mean age at presentation was 45 years (range, 28–59). The mean follow up was 24 months (range, 5–31). The mean improvement in NDI scores was 34.8. The mean PCS and MCS scores of the SF-36 test improved by 12.8 and 7.7 respectively. There was no neurological deficit. There were no cases of implant failures, migrations or subsidence. Conclusion: High patient satisfaction levels highlight the efficacy and safety of cervical disc arthroplasty, but longer term follow up is required to assess the long term functionality of the prosthesis and its protective influence on adjacent levels

Introduction: Current therapies for degenerative disc disease (DDD) are aimed at treating the pathologic and disabling conditions arising from DDD rather than directly treating the underlying problem of disc degeneration. Our group are exploring the potential of Cell Therapy to repopulate the disc and stopping the progressive loss of proteoglycans. Stem cells appear to be excellent candidates for this purpose, based on their ability to differentiate along multiple connective tissue lineages. The purpose of this study is to investigate the in-vitro interaction between muscle-deroved stem cells (MdSC) and nucleus polposus cells (NPCs) and to determine in-vivo viability of mesenchymal stem cell (MSC) in the harsh environment of the IVD. Materials and Methods: (1) Human NPCs were isolated from patients undergoing disc surgery and were co-cultured for 2 weeks with MdSCs from 3-wk-old mdx mice and in monolayer culture system at different ratios of 0:100, 25:75, 50:50, 75:25, 100:0. Proteoglycan synthesis and DNA content were measured. (2) Rabbit mesenchymal stem cells were isolated from bone marrow and tagged with a retrovirus delivered LacZ reporter gene for tracking. MSCs were then injected into a healthy rabbit IVD via 30G needle. Rabbits were sacrificed at postoperatively at 3, 6, 12 and 24 weeks. Histological analysis for MSC viability was performed. Results: (1) Co-culturing of NPCs with MdSCs in the monolayer culture system resulted in vigorous increases in proteoglycans synthesis as compared with NPCs alone. The increases were on the 200% for an NPC-to-MDSC ratio of 75:25. DNA content also increased with co-culture. (2) Histological examination revealed presence of MSCs expressing LacZ without apparent decrease in numbers or diminishment of protein production. Conclusion: The data from this study show that there is a synergistic effect between stem cells and nucleus pulposus cells resulting in upregulated proteoglycan synthesis in-vitro. Mesenchymal stem cells remain viable and continue to express an ex vivo transduced protein without appreciable cell loss for up to 24 weeks post transplantation into the rabbit IVD. These results suggest that MSCs can survive in the harsh environment of the IVD and may favourably modify ECM production. These studies support the feasibility of developing a stem cell therapy approach for DDD

Many pathological disease processes are manifested by abnormalities in cellular signalling caused by altered protein expression. Our aims, therefore, were to determine whether ‘’degenerative disc disease’’ results in 1) altered proteome expression and 2) such changes might be used as a marker for the disease process. Using gel electrophoresis, we analysed the proteome expression of nucleus pulposus (NP) derived from patients with scoliosis (‘normal’) compared to degenerate samples from patients with 1) back pain undergoing spinal fusion (DDD) and 2) sciatica undergoing discectomy (herniated nucleus pulposus or HNP). Normal NP tissue was also obtained from organ donor patients with no previous history of back pain. All samples were investigated in duplicate. Protein concentrations were measured qualitatively by visual analysis in a blinded manner and categorised into high, medium, low or absent. The Kruskal-Wallis analysis of variance was sued to analyse the data. Subsequent proteins of interest were determined on N-terminal protein sequencing. 15 samples each were collected each from scoliosis, DDD, and HNP, but only 4 samples from the organ donor groups. One major protein band difference was observed whose molecular weight was 15 kDa and N-terminal sequence homologous with lysozyme C (lysozyme-C-like-protein - LCLP). DDD and HNP samples exhibited significantly reduced levels of LCLP compared to scoliosis (P< 0.0001). All NP from donor patients exhibited high levels of LCLP, but numbers were too small for statistical analysis. No statistical correlation existed between age and LCLP levels. The true physiological roles of Lysozyme C remains unclear, but it is a known ubiquitous secretory and hydrolytic protein found in saliva, milk, cerebrospinal fluid and synovial liquid, and thought to function in primary immunity. LCLP loss in degenerate disc tissue might be due to 1) lack of production, 2) increased breakdown through a specific ubiquitin-linked pathway, or 3) polymerisation with tissue-specific amyloid deposition. The inflammatory effects within the NP related to localised LCLP-amyloid deposition offers a plausible hypothesis for patho-physiology of disc degeneration and discogenic pain. Until we determine the true nature and function of LCLP, we are no further in understanding the patho-mechanisms of disc degeneration. Moreover, LCLP loss in the NP of degenerate discs may provide a potential diagnostic marker for degenerative disc disease

Surgery for back pain remains highly controversial in view of the significant complication rate and the low likelihood of a successful clinical outcome. Over the last few years, titanium and carbon fibre interbody implants have been used to stabilise spinal motion segments following sub-total removal of disc tissue. These implants offer the theoretical advantage of immediate stabilisation, avoidance of late collapse and prevention of loss of correction of pre-operative deformity in combination with other types of segmental instrumentation such as pedicle screws. Recent long term studies have suggested the possibility of late loosening, implant migration and recurrence of segmental deformity. A recent prospective long term study of titanium cylindrical implants for lumbar degenerative disc disease has indicated that in the presence of multi-level disease, pre-existing olisthesis and levels proximal to the lumbosacral segment, the use of supplementary pedicle screw fixation is required. It appears, however, that despite improved radiological results, the use of interbody cages may not lead to superior functional outcomes when the surgery is carried out for non-specific low back pain

Our study aims to evaluate the efficacy of Wallis implant in management of discogenic back pain. We have prospectively studied thirty patients between 2006 and 2007. Average age of patients was 40.8 years. Average follow-up period 20.6 months (9-28). Main inclusion criteria includes failure of conservative management of low back pain due to degenerative disc disease, preservation of 50% of the disc height and positive discographic features. In majority of the patients the implant was put in at the level of L4-L5. Pre-op and post op SF36 and Oswestry Disability Index (ODI) scores were assessed during clinic follow-up and by telephonic interview. Mean SF36 score improved from thirty-seven (8.3 – 54.3) to 51.4. Mean ODI improved from forty-three (20-60) to 26.5(2-60) (p = 0.026). Complications including superficial infection occurred in one patient, deep infection in one patient, erosion of spinous process in one and displacement of the implant in one case. Three (10%) patients had revision surgery due to various reasons. Wallis interspinous dynamic stabilization system could be used as a soft stabilisation device avoiding fusion and short-term results are promising. In selected group of discogenic low back pain patients it is a useful interim procedure. Long-term follow-up of our series is ongoing

We present our experience with the use of the Anterior Tension Band plate (ATB) following ALIF, which utilises the existing surgical approach obviating the need for posterior fixation. The ATB is a small, smooth, low profile plate. It can be placed through the existing approach (anterolateral retroperitoneal or anterior transperitoneal) across the reconstructed level to prevent extension of the graft space and anterior migration of the spacer. The primary objective of this study is to measure radiographic fusion success in patients with lumbar degenerative disc disease using the ATB system. The secondary objective is to accurately define the clinical benefits to the patient. This is a prospective multi-center outcome study. Each patient was treated with an ATB plate at one or two levels between L2 & S1 and 1 ALIF or FRA allograft spacer per level. Patient data (VAS Pain, SF-12 and Oswestry) was collected preoperatively, and at six, twelve and twenty-four month post-operative intervals. Fusion was evaluated upon demonstration of bridging trabecular bone through or external to the femoral ring. Secondary endpoint success includes demonstration of 15% improvement over baseline on the VAS, Oswestry and SF-12 patient questionnaires. To date one hundred and thirty-one patients have undergone surgery. There were ninety-two (70%) single-level ALIF procedures and thirty-nine (30%) two-level ALIF procedures. Patients that have returned for twelve month follow-up (n=41) have had a fusion success rate of 81%. The fusion rate among one-level patients is 89% (n=25) and 67% (n=15) among two-level patients. Four of five of the un-fused two-level patients had one level fused but not the other. At twelve months, Oswestry scores improved by an average of 40% with thirty-one of forty-seven (66%) patients achieving success and VAS scores improved by 42% with thirty-five of forty-seven (75%) being successful. Preliminary analysis of current data shows positive outcomes using the ATB plating system in ALIF procedures. Primary and secondary outcomes are compatible with current standards of care, and device related complications are minimal. Further analysis of outcome data including will be reported upon the completion of the study

Traditionally, spinal fusion has been the treatment of choice for individuals who have not found pain relief for chronic back pain through conservative treatment. Premature degeneration at adjacent levels of the spine remains one of the more vexing problems facing spinal surgeons when advising relatively young people to consider lumbar fusion surgery. The use of an artificial disc to replace a damaged intervertebral disc that is generating chronic back pain is currently in various phases of development. Patients with a primary diagnosis of degenerative lumbar disc disease accompained by low back pain and unilateral leg pain, having failed conservative treatment, were considered for the surgical procedure. Twenty-eight patients were randomized into two groups of 15 and 13, respectively, using a random numbar table. Group 1 had two threaded titanium expanding fusion cages inserted posterior with bilateral medial facetectomy. Group 2 had a disc nucleus replacement device inserted posterior with unilateral medial facetectomy and hemilaminectomy. The artificial disc offers several theoretical benefits over the spinal fusion for chronic back pain including potentially enhanced clinical success rates as pain reduction and potential to avoid premature degeneration at adjacent levels of the spine by maintaining normal spinal motion

This was a retrospective review with minimum two-year follow-up of 52 patients treated between 1989 and 1998 with a variety of fixation methods. All patients had posterolateral fusions (after McNab). In addition, 27 patients had interbody fusions (23 with Brantigan or Harms cages). Fixation was by interlaminar screws in 13 (modified Nagerl technique), 18 with Roy Camille or AO notched spinal plates and in 21 with rigid fixation (6 VSP and 15 Diapason).

A good result was defined as a pain level of less than four out of 10 and an Oswestry Disability Score of less than 30%. Only 13 patients achieved a good result. The best results were seen in the patients with rigid fixation (8 out of 21). A fusion rate of 100% was achieved in patients who had an interbody cage and rigid fixation.

These results were compared with results from other papers in the literature. Social factors are important criteria for patient selection. No patient without a “significant partner” achieved a good result.

Introduction: Lumbar total disc replacement (TDR) is intended to address discogenic pain and preserve functional motion between two vertebral bodies in patients with symptomatic degenerative disc disease. TDR may thus prevent long-term subsequent accelerated degeneration at adjacent disc levels. The ProDisc®-L TDR (Synthes Spine Company, L.P., West Chester, PA) was compared to circumferential spinal fusion for the treatment of discogenic pain at one vertebral level between L3-S1 and was found to be safe, effective, and superior to fusion in patients who meet the study inclusion criteria. However the safety and efficacy of lumbar TDR at two vertebral levels is still unproven. The purpose is to compare the safety and effectiveness of the ProDisc®-L TDR to circumferential spinal fusion for the treatment of discogenic pain at two vertebral levels between L3-S1. Methods: A prospective, randomized, multi-center, FDA-regulated IDE clinical trial was conducted at 16 sites, utilizing a 2:1 randomization ratio (ProDisc®-L: Fusion). Patients were assessed pre-operatively and post-operatively at 6 weeks, 3, 6, 12, 18, and 24 months post-surgery. Each evaluation included patient self-assessments, physical and neurological examinations, and radiographic evaluation. Results: 237 patients were treated on protocol. The patient follow-up rate was 89.6% at 24 months. Overall patient demographics showed no statistically significant differences between treatment groups in age, gender, race, smoking status, height, weight, body mass index (BMI), baseline Oswestry Low Back Pain Disability Questionnaire [Oswestry Disability Index (ODI)], or prior surgical treatment. Intra-operative data showed the ProDisc®-L group was significantly lower with regard to intra-operative time (ProDisc®-L = 132 min (range 66 – 430) min; Fusion = 275 min (range 86– 515 min), p < 0.0001), estimated blood loss (ProDisc®-L = 250 ml (range 0 – 3000 ml); Fusion = 400 ml (range 0 – 2000 ml, p = 0.0006) and hospital stay (ProDisc®-L = 4 days (range 1 – 10 days); Fusion = 5 days (range 2 – 14 days), p < 0.0001). At 24 months, 90.0% of ProDisc®-L and 86.7% of Fusion patients reported improvement in ODI from pre-operative levels and 73.3% of ProDisc®-L and 55.9% of Fusion patients met the 15 point ODI improvement criteria. Overall neurological success in the ProDisc®-L group was superior to the Fusion group (ProDisc®-L = 89.2%, Fusion = 77.9%; p = 0.0260). At all follow-up time points, the ProDisc®-L patients recorded SF-36 scores significantly higher than the Fusion group (p = 0.0523). The Visual Analog Scale (VAS) pain assessment showed statistically significant improvement from pre-operative scores regardless of treatment (p < 0.0001); at 24 months, the ProDisc®-L group showed significantly higher pain reduction than the Fusion group (p = 0.0466). VAS patient satisfaction at 24 months showed a statistically significant difference favoring ProDisc®-L patients over the Fusion group (p = 0.002). Radiographic range of motion was maintained within a normal functional range. Discussion: Currently the ProDisc®-L TDR is only FDA approved for single level use. However, in this study, it has been found to be effective for the treatment of discogenic pain at two vertebral levels. In properly chosen patients, ProDisc®-L has been shown to be superior to circumferential fusion at two levels by multiple clinical criteria

Study Design/Objective: Prospective two-leg cohort study on anterior cervical fusion versus cervical arthroplasty with emphasis on clinical outcome measures.

Patients and Methods: Between August 2003 and May 2005 21 consecutive patients underwent anterior cervical fusion with or without anterior decompression with 26 levels fused. Between December 2004 and August 2006 24 patients had cervical arthroplasty with 30 levels replaced. The mean age at operation of the fusion group was 52 years and 5 months (46–69) and for the arthroplasty group 51 years and 2 months (42–62). To establish fusion the Cervios® cage (Synthes) with or without anterior plating was used. In the arthroplasty group the Prodisc C® disc prothesis (Synthes) was used. Contraindication for arthroplasty were osteoporosis, osteopathies, spinal canal stenosis, hypertrophic spondylarthrosis, spondylolisthesis, tumors and privious infection. Both groups were comparable with respect to age and gender, diagnosis, level distribution and preoperative clinical outcome measures (VAS for nack pain and arm pain, neck disability index and SF-36–sub-scores pain, function, vitality).

Results: Postoperatively all of the clinical outcome measures significantly improved in both groups. After three months postoperatively no significant further improvement was evident.

VAS neck pain: Fusion group/arthroplasty group: Preoperatively 6.2/5.9 n.s., 6 weeks 3.5/3.1 n.s., 12 weeks 2.1/1.9 n.s, 1 year 2/2.1 n.s.

In the fusion group we had 1 recurrent radiculopathy and 1 non union without the need of further intervention. In the arthroplasty group we faced 1 recurrent laryngeus recurrens nerve palsy and 3 spontaneus fusions within 1 year postoperatively, which might not be classified as complication.

Conclusion: Short term outcome after both procedures is excellent in terms of pain relief and function. 10% spontaneus fusion after disc replacement within the first year was evident. In our series we found better results after 3 months to 1 year postoperatively with respect to the neck disability index and SF-36 subscore pain within the arthroplasty group.

Introduction: Several small leucine-rich proteoglycans (SLRPs) are involved in the regulation of collagen fibril size(s) in a variety of different soft and hard musculosk-eletal tissues. In the intervertebral disc (IvD) the major SLRPs involved in regulation of types I & II collagen fibril size are believed to be decorin, fibromodulin and lumican. Research into IvD degeneration and backpain is hampered by a lack of specific biomarkers to detect and monitor the disease process. We have discovered that two keratan sulphate (KS) substituted members of the SLRP family, Keratocan and Lumican (that are major KS-pro-teoglycans found in cornea) were unusually expressed in extracts from degenerative disc tissues.

Methods: Non-degenerate disc tissue (n=10) was obtained from 2 scoliosis patients and degenerate disc tissue from 11 patients undergoing surgery. The degenerate discs were graded using criteria described by Pfir-rman et al (Spine26: 1873; 2001). Tissue samples were extracted with 4M guanidine HCl and after dialysis subjected to SDS-PAGE and Western blot analyses using monoclonal antibodies that recognise epitopes on kera-tocan and lumican.

Results & Discussion: Keratocan was not found in the non-degenerate disc tissue but was present in all degenerate IvD tissues tested. Lumican showed and increased expression in extracts of degenative IvD tissues. Our working hypothesis is that the increased expression of these two SLRPs in degenerative disc tissue results from a reparative depostion of a type I collagen fibrillar ‘scar’. This unusual expression suggests their potential as biomarkers for detecting the onset of degenrative disc disease.