Advertisement for orthosearch.org.uk
Results 1 - 20 of 93
Results per page:
Bone & Joint Research
Vol. 13, Issue 9 | Pages 452 - 461
5 Sep 2024
Lee JY Lee HI Lee S Kim NH

Aims. The presence of facet tropism has been correlated with an elevated susceptibility to lumbar disc pathology. Our objective was to evaluate the impact of facet tropism on chronic lumbosacral discogenic pain through the analysis of clinical data and finite element modelling (FEM). Methods. Retrospective analysis was conducted on clinical data, with a specific focus on the spinal units displaying facet tropism, utilizing FEM analysis for motion simulation. We studied 318 intervertebral levels in 156 patients who had undergone provocation discography. Significant predictors of clinical findings were identified by univariate and multivariate analyses. Loading conditions were applied in FEM simulations to mimic biomechanical effects on intervertebral discs, focusing on maximal displacement and intradiscal pressures, gauged through alterations in disc morphology and physical stress. Results. A total of 144 discs were categorized as ‘positive’ and 174 discs as ‘negative’ by the results of provocation discography. The presence of defined facet tropism (OR 3.451, 95% CI 1.944 to 6.126) and higher Adams classification (OR 2.172, 95% CI 1.523 to 3.097) were important predictive parameters for discography-‘positive’ discs. FEM simulations showcased uneven stress distribution and significant disc displacement in tropism-affected discs, where loading exacerbated stress on facets with greater angles. During varied positions, notably increased stress and displacement were observed in discs with tropism compared to those with normal facet structure. Conclusion. Our findings indicate that facet tropism can contribute to disc herniation and changes in intradiscal pressure, potentially exacerbating disc degeneration due to altered force distribution and increased mechanical stress. Cite this article: Bone Joint Res 2024;13(9):452–461


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXI | Pages 142 - 142
1 May 2012
D. C J. P D. S
Full Access

The management of discogenic pain continues to be controversial. The results for operative and non-operative management are variable. This study aims to look at the results of interbody fusion versus dynamic stabilisation in patients with discogenic pain. Diagnosis was made by use of MRI and provocative discography. All patients had pre-operative Visual Analogue Scores and Oswestry Disability Index scores. Patients were then assessed in the post-operative period at 6 months, 1 year and 2 years. Case matched series with 19 patients in each group with a mean follow-up of 24 months. In comparison of both techniques there were no statistically significant differences but the dynamic stabilisation group had improved outcomes with both measures. The results did raise some further issues, as several patients in each group were either worse or had no significant improvement following surgery. In conclusion this paper raises concerns regarding the use of surgery for patients with discogenic pain. If surgery is however considered, dynamic stabilisation is a valid alternative to interbody fusion


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_X | Pages 3 - 3
1 Apr 2012
Cumming D Powell J Sharp D
Full Access

To assess the effectiveness of dynamic stabilisation as a treatment for discogenic pain compared to standard treatment of interbody fusion. All patients were referred for a 2 year back-pain management programme. Patients with continued pain following conservative treatment underwent discography & MRI. Patients with painful degenerate discs on the above investigations were selected. Patients underwent interbody fusion (PLIF/TLIF) or dynamic stabilisation. Mean follow-up was 24 months with a minimum follow-up of 12 months. All patients had pre-operative ODI and VAS scores. Patients were then sent further questionnaires at 6 month intervals. The mean improvement in ODI following dynamic stabilisation was 20% (-20% → 56%), the mean improvement in the pain score was 2.4 (0→8). The mean improvement in ODI following interbody fusion was 11% (-14%→48%), the mean improvement in the pain score was 2.6 (-4→9). 10 patients in the dynamic stabilisation group had a greater than 20% improvement in ODI, 7 patients in the interbody fusion group had similar results. The above results demonstrate that dynamic stabilisation is at least as effective at treating discogenic pain as interbody fusion. The results however do question the validity of either interbody fusion (PLIF/TLIF) or dynamic stabilisation in the management of discogenic pain


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_I | Pages 45 - 45
1 Jan 2012
Cumming D Powell J Sharp D
Full Access

Objective. To assess the effectiveness of dynamic stabilisation as a treatment for discogenic pain compared to standard treatment of interbody fusion. Study Design & Subjects. All patients were referred for a 2 year back-pain management programme. Patients with continued pain following conservative treatment underwent discography & MRI. Patients with painful degenerate discs on the above investigations were selected. Patients underwent interbody fusion (PLIF/TLIF) or dynamic stabilisation. Mean follow-up was 24 months with a minimum follow-up of 12 months. Outcome Measures. All patients had pre-operative ODI and VAS scores. Patients were then sent further questionnaires at 6 month intervals. Results. The mean improvement in ODI following dynamic stabilisation was 20% (-20% → 56%), the mean improvement in the pain score was 2.4 (0→8). The mean improvement in ODI following interbody fusion was 11% (-14%→48%), the mean improvement in the pain score was 2.6 (-4→9). 10 patients in the dynamic stabilisation group had a greater than 20% improvement in ODI, 7 patients in the interbody fusion group had similar results. Conclusion. The above results demonstrate that dynamic stabilisation is at least as effective at treating discogenic pain as interbody fusion. The results however do question the validity of either interbody fusion (PLIF/TLIF) or dynamic stabilisation in the management of discogenic pain


Orthopaedic Proceedings
Vol. 84-B, Issue SUPP_II | Pages 143 - 143
1 Jul 2002
Goswami A Knight M Freemont A
Full Access

Introduction: Recent cadaveric studies have identified neovascularisation and neoneuralisation as probable mechanisms in the causation of discogenic pain. Calcium pyrophosphate deposits have been observed in discs in several studies. Their significance in the causation of discogenic pain is unclear. Direct correlation between the pain site and histological features can be verified by aware state endoscopic visualisation. Aim and Objectives: The study aims to examine and correlate the presence of neovascularisation, crystalline pyrophosphate deposits in the disc, and discogenic pain by spinal probing and discography under endoscopic visualisation. Material and Methods: Tissue removed from intervertebral discs of 224 patients during surgery was examined directly, and polarised microscopy was used to identify the presence of calcium pyrophosphate and neovascularisation. Their presence was correlated to diagnostic provocative findings of spinal probing and discography and intradiscal distortion during aware state endoscopy. Results: Calcium Pyrophosphate: Twenty out of 224 patients (9%) demonstrated calcium pyrophosphate in the discs. Fourteen had pain reproduced on probing or discography. Thirteen out of 20 patients (65%) had either an annular collection or leak at the index level. 6 had an extradiscal cause of pain. One hundred percent of the patients with annular collections or leaks had pain on spinal probing or discography. Sixteen patients with pyrophosphate deposits did not have neovascularisation. Neovascularisation: Thirty seven out of 224 patients (16.5%) showed neovascularisation in the disc. Four discs had crystalline pyrophosphate deposits. Thirty three out of 37 (90%) had pain on probing and/or discography. Out of four patients who had no pain on probing or discography, two had demonstrated tears during previous discographic procedures which were treated with laser annealing. These patients had disc bulges and compressive radiculopathy. Conclusion: The presence of pyrophosphate in the disc without a tear or leak does not directly render them tender to provocation. The presence of pyrophosphate is not correlated to neovascularisation. Annular tears or leaks are not directly correlated to the presence of pyrophosphates. There is a high correlation between pain provocation and neovascularisation


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 219 - 219
1 Mar 2010
Ardern D Cain C Hall D
Full Access

Anterior lumbar interbody fusion (ALIF) is an accepted surgical treatment for disabling discogenic pain. Additional posterior fixation has been advocated. This is a prospective clinic al study evaluating a stand-alone anterior fusion cage with an integrated titanium plate and four divergent locking screws. Patients who had failed conservative management for lumbar discogenic pain were recruited into the study. All underwent diagnostic discography. Surgery was performed through an anterior retro-peritoneal approach. The fusion cage was packed with autogenous bone graft. Outcome measures included: Visual Analogue Scores (VAS), Oswestry Disability Index (ODI) and SF-36 data. Fine-cut CT was performed at one and two years post-operatively. Fusion was defined as continuous bony trabeculae joining the vertebral bodies. Fifty levels were operated on in 39 patients with a mean age of 40.8 years (22–55). The mean operative time was less than 120 minutes, and mean blood loss less than 100 mls. Radiographic fusion at one year was 78% and 100% at two years. Two year mean VAS sc ores for back pain improved from 7.0 to 3.7 (p< 0.01) and for leg pain from 6.1 to 3.1 (p< 0.01). The mean ODI scores decreased from 50.7 to 31.7 (p< 0.01), and SF-36 (PCS) scores increased from 28.4 to 37.5 (p< 0.01). There were no major complications and no patients have required supplementary posterior fixation. This technique is safe and is as effective as 360° fusion in achieving fusion in the management of discogenic back pain over one and two levels. This technique has the advantage of avoiding the morbidity associated with additional posterior fixation


Orthopaedic Proceedings
Vol. 84-B, Issue SUPP_III | Pages 326 - 326
1 Nov 2002
Goswami AKD Knight MTN Freemont AJ
Full Access

Objectives: To examine and correlate the presence of neovascularisation, crystalline pyrophosphate deposits and other hisotological features in the disc and discogenic pain established by spinal probing and discography under aware state endoscopic visualisation. Design: Tissue removed from intervertebral discs of 224 patients during surgery were examined by direct and polarised microscopy to identify the presence of calcium pyrophosphate and neovascularisation. Material and Methods: Histology was correlated to the diagnostic provocative findings of spinal probing and discography, discal palpation during aware state endoscopy. Results:Calcium Pyrophosphate: 20/224 (9%) patients demonstrated calcium pyrophosphate in the discs. Fourteen had pain reproduced on probing or discography; 13/20 (65%) of patients had either an annular collection or leak at the index level; 6/20 had an extradiscal cause of pain. Neovascularisation: Thirty-seven out of 224 (16.5%) patients showed neovascularisation in the disc; four discs had crystalline pyrophosphate deposits; 33/37 (90%) had pain on probing and/or discography. Conclusion: The presence of pyrophosphate in a disc without a tear or leak is not associated with annular tenderness. The presence of pyrophosphates in radial tears or leaks is associated with annular tenderness. Annular tears or leaks are not directly correlated to the presence of pyrophosphates. There is a high correlation between pain provocation and neovascularisation


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 15 - 15
1 Jul 2014
Binch A Phillips K Chiverton N Cole A Breakwell L Michael A Cross A Le Maitre C
Full Access

Summary. Cytokines produced within the degenerate disc induce expression of neurotrophic factors and pain related peptides which could be important in nerve ingrowth and pain sensitisation leading to low back pain. The intervertebral disc (IVD) is considered the largest aneural and avascular structure within the human body, yet during degeneration vascularisation of the IVD is seen to be accompanied by nociceptive nerves. Low back pain is a highly debilitating condition affecting around 80% of the population, 40% of which are attributed to IVD degeneration. Discogenic pain was largely thought to be a result of irritation and compression of the nerve root, yet recent data suggests that pain may be attributed to the sensitisation of sensory nerves by the synthesis of pain related peptides, calcitonin gene related peptide (CGRP) and substance P. It is known that cytokines and chemokines produced by nucleus pulposus cells elicit various effects including the production of matrix degrading enzymes, and decreased matrix molecules. Here, we investigate the hypothesis that cytokines regulate both neurotrophic factor and pain related peptide synthesis within nucleus pulposus and nerve cells which may elicit algesic effects. Real-Time PCR was performed to investigate gene expression of the neurotrophic factors NGF, BDNF, NT3 and their receptors Trk A, B and C along with Substance P and CGRP on directly extracted RNA from human NP cells and NP cells cultured in alginate for 2 weeks prior to treatment for 48hours with IL-1, IL-6 or TNFα at 0–100ng/mL. Similarly SH-SY5Y neuroblastoma cells were differentiated in retinoic acid for 7 days prior to stimulation with IL-1, IL-6 or TNFα at 0ng/mL and 10ng/mL for 48hours. Immunohistochemistry was used to localise neurotrophic factor receptors Trk A, B and C in both degenerate discs and neuronal cells. NGF expression was present in normal and degenerate disc samples, however only degenerate discs expressed the high affinity receptor TrkA. Similarly Trk B was present in 22% of normal samples increasing to 100% expression within degenerate disc samples. All cytokines increased expression of NGF in NP cells (P≤0.05). TNFα also increased BDNF significantly, whereas no significant affects were seen in NT3 expression in NP cells. Trk B expression was significantly increased by IL-1 and TNFα treatment of NP cells. Conversely Trk C was down regulated by IL-6. Substance P was significantly increased by IL-1 and TNFα treatments whilst IL-6 and TNFα increased CGRP expression in NP cells. In SH-SY5Y cells, IL-1 significantly increased BDNF whilst IL-6 and TNFα failed to induce significant differences in neurotrophic factors. All cytokines increased Trk expression in the nerve cell line; however this failed to reach significance. Immunohistochemistry confirmed the presence of Trk receptors within the neuronal cell line. Here we have demonstrated that a number of cytokines known to be up regulated during disc degeneration and disc prolapse, induce expression of various neurotrophic factors, their receptors and pain related peptides within human NP cells, as well as SH-SY5Y cells. This data suggests that the presence and production of cytokines within the degenerate disc may be responsible for nerve ingrowth and sensitisation of nerves which may result in discogenic pain


The Journal of Bone & Joint Surgery British Volume
Vol. 68-B, Issue 1 | Pages 142 - 143
1 Jan 1986
Weatherley C Prickett C O'Brien J

Persistent back pain in the presence of an intact posterior fusion is commonly seen and is often regarded as being psychogenic in origin. This paper discusses five patients, all of whom were chronically disabled by such pain; all five had a confirmed posterior and/or lateral fusion. In each case lateral discography identified the disc within the fused segment as the source of symptoms and pain relief was obtained with an anterior interbody fusion. This source of pain should be considered as a possibility in similar cases of failed back surgery.


Orthopaedic Proceedings
Vol. 84-B, Issue SUPP_III | Pages 328 - 328
1 Nov 2002
Ahuja S Russell ID Howes J Davies PR
Full Access

Purpose: The purpose of this prospective study is to evaluate the benefits of this treatment for discogenic back pain. Method: Thirty-four patients with chronic discogenic back pain underwent this therapy. All the patients had a failed trial of conservative treatment. Patients with a positive provocative discogram were selected for intra-discal electrothermal therapy (IDET). The outcome is assessed using a SF 36 questionnaire filled in pre-procedure and then at three, six, twelve and eighteen months and two years post-operatively. Results: The mean age group of the patients was 37 years (range 15–58 years). All the patients had a minimum follow up of 12 months (range 6–2 years). Out of the 34 patients 5(14%) had no improvement and had to undergo an interbody fusion following IDET. No patient developed any neurological complications. At a minimum of one year follow-up 56% patients had improvement in physical function scores and 52% had improvement in pain scores as per the SF 36. Conclusion: Thus IDET appears to be an effective procedure in the short-term relief of discogenic back pain in patients who otherwise might be candidates for fusion


The Journal of Bone & Joint Surgery British Volume
Vol. 78-B, Issue 4 | Pages 606 - 612
1 Jul 1996
Nakamura S Takahashi K Takahashi Y Yamagata M Moriya H

The afferent pathways of discogenic low-back pain have not been fully investigated. We hypothesised that this pain was transmitted mainly by sympathetic afferent fibres in the L2 nerve root, and in 33 patients we used selective local anaesthesia of this nerve. Low-back pain disappeared or significantly decreased in all patients after the injection. Needle insertion provoked pain which radiated to the low back in 23 patients and the area of skin hypoalgesia produced included the area of pre-existing pain in all but one. None of the nine patients with related sciatica had relief of that component of their symptoms. Our findings show that the main afferent pathways of pain from the lower intervertebral discs are through the L2 spinal nerve root, presumably via sympathetic afferents from the sinuvertebral nerves. Discogenic low-back pain should be regarded as a visceral pain in respect of its neural pathways. Infiltration of the L2 nerve is a useful diagnostic test and also has some therapeutic value


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_III | Pages 233 - 233
1 Sep 2005
Mayahi R Khot A Sharp D Powell J
Full Access

Study Design: A retrospective study of the clinical outcome of patients with lumbar discogenic pain with Modic changes on MRI prior to intradiscal steroid injection. Objectives: To determine whether the clinical outcome of patients with discogenic back pain who underwent intradiscal steroid injection could be predicted from MRI Modic changes. Methods: The pre-operative scans were studied by two senior spinal surgeons. The lumbar vertebral end-plate changes were then classified according to the method described by Modic. The intra- and inter-observer ratings were satisfactory. Subjects: 40 patients with discogenic back pain were recruited in this study. The mean age was 43.6 years (23 to 72 years). The male to female ratio was 1 to 1. Outcome Measures: The clinical outcomes at six months post-intradiscal steroid injection were correlated with the Modic changes. The clinical outcomes were assessed using visual analogue scores for back pain as well as Oswestry disability index (ODI). At least a 2-point improvement in visual analogue score and a 20-point improvement in ODI were required to indicate significant symptomatic relief. Results: We found that in those patients without Modic changes there was improvement of the low back pain in 9% (1/11). In those with Modic I changes there were significant relief in 64% (9/14), moderate relief in 29% (4/14) and no relief in 7% (1/14). In those with Modic II changes there were significant relief in 27% (4/15), moderate relief in 27% (4/15) and no relief in 47% (7/15). There were no cases with Modic III changes. Conclusions: Previous studies on intradiscal steroid injections have shown variable results. Two prospective double-blind clinical trials, using intradiscal steroids, identified no significant benefit or improvement in the clinical outcome. Our results however suggest that patients with Modic I changes on MRI are most likely to benefit from intradiscal steroid injection in the short term


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXVI | Pages 14 - 14
1 Jun 2012
Lau S Muller M Latiff A Shepperd J
Full Access

Purpose of Study. To review the medium-term results of the Dynesys stabilisation system used in 113 consecutive patients with discogenic back pain. Methods and Results. 113 consecutive patients with discogenic back pain were treated with Dynesys as the sole intervention. Inclusion criteria included mri proven disc degeneration and an improvement in symptoms following an injection into the disc with local anaesthetic and steroid (spinal disc probing). Patients were followed up for a minimum of 5 years, with outcome measures including SF-36, Oswestry disability index (ODI) and visual pain analogue scores (VPAS). Additional factors reviewed included previous spinal operations, complications, loosening and revision rates with subsequent outcomes. Mean pre-operative ODI was 49.5, SF-36 was 37.6 and VPAS back pain was 60.9. At one year post operatively, these scores were 36.9, 49.4 and 39.8, at five years follow up, the scores were 33.3, 51.8 and 40.1 respectively. We note wide variations in our results. Several significant factors appear to contribute to the outcome of surgery. These include undergoing surgery before the age of 43, no more than 2-level disc degeneration, leg pain less than VPAS 4, and no previous spinal surgery. 19 patients had screw loosening evident on plain film x-rays (4 requiring removal), and 2 patients had screw breakages. 19 patients had implant removal for failure and 2 patients went on to have a fusion procedure. Discussion. Dynesys has a role in the treatment of discogenic back pain. Patient selection is important to outcome and we have identified several pre-operative factors that increase the likelihood of success. The effects are present at 1 year postoperatively and are maintained for at least 5 years. There is a significant screw loosening rate and our series had a 17% revision rate


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_IV | Pages 460 - 460
1 Apr 2004
McCombe P
Full Access

Introduction: Surgical management of discogenic low back pain has in the past been limited to spinal fusion. Recently disc arthroplasty has become available. The rationale for disc arthroplasty is that it may avoid the long term consequences of adjacent segment degeneration. Avoidance of long term consequences is of no value unless the short term outcome is at least equivalent between fusion and arthroplasty.

Methods: A series of patients with chronic low back pain with concordant lumbar discography and a negative control discogram were surgically treated. Prospective data was collected preoperatively and at regular intervals during the post-operative period for a historical series of combined anterior and posterior lumbar fusion (n =24), a series of SB Charité (DePuy Spine) disc replacements (n =23), and recently, a series of Maverick (Medtronic Sofamor Danek) artificial disc replacements (n =9). Self assessed outcome measures of visual analog pain score (VAS), Low Back Outcome Score (LBOS) and SF12 general health data was obtained at intervals after the surgery. This paper presents the results of the consecutive series that have a minimum of 3 months follow-up.

Results: The data for the two groups of arthroplasty was combined and compared to the fusion group. The mean age for the fusion group was 37.6 years and the mean age for the arthroplasty group was 38.6 years. There were 5 compensation cases (20.8 %) in the fusion group and 5 cases (15.6 %) in the arthroplasty group. Both groups had 69% male patients. The mean VAS dropped from 7.5 to 3.7 (p< 0.001) in the arthroplasty group and from 7.3 to 3.5 (p< 0.001) in the fusion group. The mean LBOS improved from 22.0 to 36.5 (p< 0.001) in the arthroplasty group and from 19.6 to 37.1 (p< 0.001) in the fusion group.

There was no apparent difference between the clinical improvement in VAS and LBOS (p=0.91 and p=0.45 respectively) for each group. Analysis of the power of the comparison showed an 86% power for comparison of VAS improvement using a clinically important difference (delta) of 1 VAS point and there was 98% power for the LBOS improvement comparison using a clinically important difference (delta) of 10 LBOS points. Complications appeared higher in the arthroplasty group with foraminal encroachment requiring revision in 3 cases and one case of polyethylene failure in the Charité group at 3 years. This case occurred with an 8mm polyethylene insert (since removed from inventory by the manufacturer)

Discussion: Disc arthroplasty in the lumbar spine appears to offer similar short term results to that of fusion for chronic low back pain. The surgical complication rate may be higher in the early learning curve of the procedure.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_2 | Pages 93 - 93
2 Jan 2024
Bermudez-Lekerika P Tseranidou S Kanelis E Crump K Le Maitre C Wuertz-Kozak K Alexopoulos L Noailly J Gantenbein B
Full Access

Intervertebral disc (IVD) degeneration is a pathological process often associated with chronic back pain and considered a leading cause of disability worldwide. 1. During degeneration, progressive structural and biochemical changes occur, leading to blood vessel and nerve ingrowth and promoting discogenic pain. 2. In the last decades, several cytokines have been applied to IVD cells in vitro to investigate the degenerative cascade. Particularly, IL-10 and IL-4 have been predicted as important anabolic factors in the IVD according to a regulatory network model based in silico approach. 3. Thus, we aim to investigate the potential presence and anabolic effect of IL-10 and IL-4 in human NP cells (in vitro) and explants (ex vivo) under hypoxia (5% O2) after a catabolic induction. Primary human NP cells were expanded, encapsulated in 1.2% alginate beads (4 × 106 cells/ml) and cultured for two weeks in 3D for phenotype recovery while human NP explants were cultured for five days. Afterwards, both alginate and explant cultures were i) cultured for two days and subsequently treated with 10 ng/ml IL-10 or IL-4 (single treatments) or ii) stimulated with 0.1 ng/ml IL-1β for two days and subsequently treated with 10 ng/ml IL-10 or IL-4 (combined treatments). The presence of IL-4 receptor, IL-4 and IL-10 was confirmed in human intact NP tissue (Fig 1). Additionally, IL-4 single and combined treatments induced a significant increase of proinflammatory protein secretion in vitro (Fig. 2A-C) and ex vivo (Fig. 2D and E). In contrast, no significant differences were observed in the secretome between IL-10 single and combined treatments compared to control group. Overall, IL-4 containing treatments promote human NP cell and explant catabolism in contrast to previously reported IL-4 anti-inflammatory performance. 4. Thus, a possible pleiotropic effect of IL-4 could occur depending on the IVD culture and environmental condition. Acknowledgements: This project was supported by the Marie Skłodowska Curie International Training Network “disc4all” under the grant agreement #955735. For any figures and tables, please contact the authors directly


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_11 | Pages 27 - 27
1 Sep 2021
Hess GM Golan J Mozsko S Duarte J Jarzem P Martens F
Full Access

Lumbar fusion remains the gold standard for the treatment of discogenic back pain. Total disc replacement has fallen out of favor in many institutions. Other motion preservation alternatives, such as nucleus replacement, have had limited success and none are commercially available at this time. Two prospective, nonrandomized multicenter studies of lumbar disc nucleus replacement using the PerQdisc 2.0 nucleus replacement device in patients with lumbar discogenic back pain. Early clinical results are presented. A total of 16 patients from 4 international sites (Germany, Paraguay, Canada and Belgium) were enrolled in the trial between May 2019 and February 2021. Data collection points include baseline and postoperatively at 1, 2, 6, and 12 months. Clinical outcome measures were obtained from the Visual Analog Scale (VAS) for back and leg pain, Oswestry Disability Index (ODI), SF-12V2, Analgesic Score (AS), and radiographic assessments. Prospectively gathered data on patient reported outcomes, neurological outcome, surgical results, radiological analysis, and any adverse events. 16 patients had successful implantation of the device. There have been no expulsions of the device. Early postoperative results are available in 13/16 patients at 6 months and 11/16 patients at 12 months. There have been 4 (25%) revision surgeries 3–12 months post implantation between the two trials. 12 of 13 (92%) patients had Minimal Clinically Important Difference (MCID) in ODI at 6 months and 10 of 11 (91%) at 12 months. Mean decrease in ODI from baseline to 12 months was 44.8. At 12 months 8 (73%) patients are not taking pain medication, 1 (9%) patient is taking a narcotic for pain management. 73% of patients are working without restrictions at 12 months post implant. Early clinical and technical results are encouraging. Long term follow up is essential and is forthcoming. Additional patient recruitment and data points are ongoing. FDA/Drug Status Investigational/Not approved


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


Orthopaedic Proceedings
Vol. 84-B, Issue SUPP_III | Pages 335 - 335
1 Nov 2002
Sharp DJ
Full Access

Aim: To investigate the use of the Graf Dynamic Stabilisation System for the treatment of multi-level discogenic pain associated with symptoms of ‘instability’. Introduction: Indications for the use of the Graf Ligament system remain controversial. There is a small group of patients who present with severely disabling pain with failed conservative treatment, of discogenic origin at more than one level, and associated with symptoms of so-called ‘instability’ (acute pain related to position and movement), for whom treatment is extremely difficult. Methods: Twenty-two consecutive adult patients of working age with this clinical picture, with discogenic pain at two or three levels confirmed by discography, were treated with the Graf Ligament System. They were prospectively studied, and reviewed by an independent assessor. Results: At an average of three year follow up, 50% had good or excellent results including return to work, 18% fair, and 32% were no better. None were worse. Correlation with pre-operative MRI findings and complications will be discussed. Conclusions: Whilst such dynamic systems may have a role in the treatment of discogenic pain, the success rate in this series does not justify its continued use for this indication without further research into the theoretical basis of the action of such dynamic stabilisation systems and the entry of all cases into prospective controlled trials


The Journal of Bone & Joint Surgery British Volume
Vol. 89-B, Issue 9 | Pages 1135 - 1139
1 Sep 2007
Edgar MA

The anatomical studies, basic to our understanding of lumbar spine innervation through the sinu-vertebral nerves, are reviewed. Research in the 1980s suggested that pain sensation was conducted in part via the sympathetic system. These sensory pathways have now been clarified using sophisticated experimental and histochemical techniques confirming a dual pattern. One route enters the adjacent dorsal root segmentally, whereas the other supply is non-segmental ascending through the paravertebral sympathetic chain with re-entry through the thoracolumbar white rami communicantes. Sensory nerve endings in the degenerative lumbar disc penetrate deep into the disrupted nucleus pulposus, insensitive in the normal lumbar spine. Complex as well as free nerve endings would appear to contribute to pain transmission. The nature and mechanism of discogenic pain is still speculative but there is growing evidence to support a ‘visceral pain’ hypothesis, unique in the muscloskeletal system. This mechanism is open to ‘peripheral sensitisation’ and possibly ‘central sensitisation’ as a potential cause of chronic back pain


Orthopaedic Proceedings
Vol. 84-B, Issue SUPP_III | Pages 327 - 327
1 Nov 2002
Khot A Bowditch MG Powell JM Sharp. DJ
Full Access

Objective: To report a randomised controlled trial (RCT) of the therapeutic efficacy of intradiscal steroid injection for the treatment of discogenic back pain after two years. Introduction: Discography remains the main method to assess whether a degenerate disc is the source of back pain. The treatment of such discogenic pain is difficult. There is only one previous RCT of the use intradiscal steroids, but with a short follow-up. Patients and Methods: 120 consecutive patients with positive discography were randomised intra-operatively to receive an intradiscal injection of saline or 40mgs Depomedrone. Outcome was assessed using a back pain questionnaire at six weeks, three and six months, and at two years. Pain (using a visual analogue score), disability (the Oswestry Disability Index), and psychological status (DRAM score) were measured. The results were correlated with Modic changes and high intensity zones on MRI scan. Results: An initial improvement of back pain in the steroid group is not maintained at two years, with no statistical difference between the two groups. Correlation of the results with the MRI findings will be presented. Conclusion: This study demonstrates the need for long-term follow-up of such intradiscal therapeutic methods of treating discogenic pain