Intraoperative findings, complications, and short-term results after lumbar microdiscectomy with or without implantation of annular closure device.

BACKGROUND: Standard microscopic lumbar discectomy (MLD) is a short operation with minimal blood loss, and a low rate of peri- and intraoperative complications. The objective of this study was to evaluate intraoperative findings, complications, and early postoperative neurological outcome (< 105 days) in patients undergoing MLD with or without implantation of an annular closure device (ACD). METHODS: This study is based on data analysis of a post-marketing, prospective, multicenter RCT in Europe including patients undergoing standard MLD with or without implantation of an ACD (Barricaid®, Intrinsic Therapeutics, Inc., Woburn, MA). Enrollment of 554 patients in 21 centers in Europe (Germany, Switzerland, Austria, Belgium, The Netherlands, and France) started in 2010 and was completed in October 2014, with 276 patients randomized to the ACD group and 278 to the control group. RESULTS: Mean operation time was 70 min in the ACD group and 52 min in the control group (p < 0.0001). Intraoperative fluoroscopy time was 24 s in the ACD group and 7 s in the control group (p < 0.0001). Average blood loss was 94.2 ml in the ACD group and 64.7 ml in the control group (p = 0.0001). Serious device- or procedure-related adverse events occurred in 3.7% (10/272) of the ACD group and 7.9% (22/278) of the control group. Dural injuries occurred in 13 (4.8%) patients in the ACD group and 7 (2.5%) in the control group. There was one device-related nerve root injury resulting in a nerve root amputation. Surgical complications included 3 hematomas in the ACD group and 4 in the control group; 3 infections occurred in both groups. Device migrations were documented in 3 patients in the ACD group. Patients in the ACD group (n = 7, 2.6%) underwent fewer reoperations compared with that in the control group (n = 16, 5.8%, OR = 2.3 (0.9-5.7)). Mean VAS leg pain at 3 months was 11.9 in the ACD and 15.1 in the control group, respectively. CONCLUSION: Short-term outcome after MLD with or without implantation of ACD was similar in both groups. Patients included in the ACD group underwent fewer reoperations in the first 3 months after surgery. Nevertheless, longer operation time, higher amount of blood loss, and risk of nerve root lesion during device implantation should be considered additional risks in patients undergoing ACD implantation after MLD.

Sagittal alignment assessment after short-segment lumbar fusion for degenerative disc disease.

PURPOSE: To investigate whether differences in spinopelvic parameters, and especially spinopelvic alignment, could be associated with adjacent segment disease (ASD) or pseudarthrosis after short-segment lumbar fusion. METHODS: Retrospective study of patients offered mono- or bisegmental transforaminal lumbar interbody fusion (TLIF) with polyetheretherketone (PEEK) or titanium cages, due to degenerative disease. Of 419 patients, 32 (7.6%) presented pseudarthrosis (nonunion group), 29 (6.9%) developed symptomatic ASD (ASD group), and 358 patients (85.5%) showed evidence of uncomplicated fusion (control group). Standard spinopelvic parameters were measured in all patients before and after surgery. The differences of the values within the parameters (Δ values) were also calculated. A comparative analysis within and among groups was performed. Patients were also analyzed by cage characteristics (large vs small, titanium vs PEEK). RESULTS: All studied parameters changed significantly after surgery both in the control and ASD group, while in the nonunion group, only LL and PI-LL changed significantly (PI-LL increased from 10 ± 11° to 14 ± 10°, p = 0.008). Patients in the nonunion group presented greater SS before and after surgery, greater PI-LL after surgery, and higher PI, while ASD patients presented greater absolute mean ΔPT value. Age, size, and type of cage were not related to fusion, nonunion, or ASD. CONCLUSIONS: Greater SS, greater PI, and a PI-LL mismatch greater than 10° are associated with failed bony fusion, while ASD is related to a greater difference between the pre-operative and post-operative values of PT. Neither the type nor the size of cage seem to have a significant impact on either solid bony fusion, nonunion, or ASD rates. Thus, we recommend on the study of patients' sagittal alignment in the pre-operative setting even when treating patients with short-segment lumbar interbody fusion.

Annular closure device for disc herniation: meta-analysis of clinical outcome and complications.

BACKGROUND: Lumbar intervertebral disc herniation is a common cause of lower back and leg pain, with surgical intervention (e.g. discectomy to remove the herniated disc) recommended after an appropriate period of conservative management, however the existing or increased breach of the annulus fibrosus persists with the potential of reherniation. Several prosthesis and techniques to reduce re-herniation have been proposed including implantation of an annular closure device (ACD) - Barricaid™ and an annular tissue repair system (AR) - Anulex-Xclose™. The aim of this meta-analysis is to assist surgeons determine a potential approach to reduce incidences of recurrent lumbar disc herniation and assess the current devices regarding their outcomes and complications. METHODS: Four electronic full-text databases were systematically searched through September 2017. Data including outcomes of annular closure device/annular repair were extracted. All results were pooled utilising meta-analysis with weighted mean difference and odds ratio as summary statistics. RESULTS: Four studies met inclusion criteria. Three studies reported the use of Barricaid (ACD) while one study reported the use of Anulex (AR). A total of 24 symptomatic reherniation were reported among 811 discectomies with ACD/AR as compared to 51 out of 645 in the control group (OR: 0.34; 95% CI: 0.20,0.56; I2 = 0%; P < 0.0001). Durotomies were lower among the ACD/AR patients with only 3 reported cases compared to 7 in the control group (OR: 0.54; 95% CI: 0.13, 2.23; I2 = 11%; P = 0.39). Similar outcomes for post-operative Oswestry Disability Index and visual analogue scale were obtained when both groups were compared. CONCLUSION: Early results showed the use of Barricaid and Anulex devices are beneficial for short term outcomes demonstrating reduction in symptomatic disc reherniation with low post-operative complication rates. Long-term studies are required to further investigate the efficacy of such devices.

Implantation of a bone-anchored annular closure device in conjunction with tubular minimally invasive discectomy for lumbar disc herniation: a retrospective study.

BACKGROUND: Minimally invasive techniques for lumbar discectomy have been recommended as superior to open techniques due to lower blood loss, lower rates of infection and shorter recovery. There are, however, concerns that this approach does not sufficiently remove the herniated nuclear material, thus leaving the patient susceptible to reherniation requiring reoperation. The purpose of this study was to examine the safety and viability of an annular closure device in limiting reherniation and reoperation in a cohort of patients undergoing minimally invasive lumbar discectomy with the assistance of an annular closure device. METHODS: We retrospectively analysed the results from patients treated by a single surgeon between March 2011 and December 2017. All patients had been diagnosed with a large (≥ 5 mm) defect and were treated via minimally invasive surgical techniques. Outcomes included demographic data, the procedural duration and the rates of symptomatic reherniation and reoperation. RESULTS: 60 patients were included in the study. The mean age was 42 years (range: 19-66); mean BMI was 24.1 (range: 16.7-36.3). Mean surgical duration was 29 min (range: 16-50). Reoperation was required in 5% (3/60) of patients, although only 3% (2/60) experienced symptomatic reherniation at the index level. No other complications were reported. CONCLUSIONS: In our study, the use of an annular closure device during minimally invasive lumbar discectomy in a population of patients with large herniations was associated with low rates of reherniation and reoperation at the index level. While more research is required, the results of this study demonstrate the safety and viability of the annular closure device as an adjunct to minimally invasive discectomy.

Symptomatic annulus-repair-device loosening due to a low-grade infection.

We report the unusual case of a young patient with reoperation after annuloplasty using the Barricaid® (Intrinsic Therapeutics, Woburn, MA, USA) closure device. Our patient, a 32-year-old man underwent lumbar discectomy and annuloplasty of the level L5-S1. Five years later, the patient presented with a new onset of low-back pain radiating into the right leg. Imaging revealed loosening of the annulus repair device. The device was removed surgically and the patient was pain free thereafter. Annular closure devices such as the Barricaid system aim to improve outcome after lumbar discectomy by reducing the risk of recurrent disc herniation of the same level. Data on long-term follow-up are missing. Here we present, to our knowledge, the first case of symptomatic device loosening.

Stepwise illustration of teeth-fixation semi-constrained cervical disc arthroplasty.

There are many kinds of artificial discs available for cervical disc arthroplasty (CDA), with various designs of fixation and articulation mechanisms. Each of these designs has different features and theoretically fits most optimally in selected types of patients. However, there has been insufficient literature to guide individualized selection among these CDA devices. Since CDA aims to restore the joint function rather than arthrodesis, tailor-made size, shape, and mechanical properties should be taken into account for each candidate's target disc. Despite several large-scale prospective randomized control trials that have demonstrated the effectiveness and durability of CDA for up to 8 years, none of them involved more than one kind of artificial disc. In this video the authors present detailed steps and technical aspects of the newly introduced ProDisc-C Vivo (DePuy Synthes Spine), which has the same ball-and-socket design for controlled, predictable motion as the ProDisc-C. The newly derived teeth fixation provides high primary stability and multilevel capability by avoidance of previous keel-related limitations and complications (e.g., split vertebral fracture). Please note that the ProDisc-C Vivo is currently not available on the US market. The authors present the case of a 53-year-old woman who had symptoms of both radiculopathy and myelopathy caused by a large, calcified disc herniation at C4-5. There was no improvement after 4 months of medical treatment and rehabilitation. A single-level CDA was successfully performed with the ProDisc-C Vivo, and her symptoms were completely ameliorated afterward. The follow-up images demonstrated preservation of motion at the indexed level. The video can be found here: https://youtu.be/4DSES1xgvQU .

Unilaterally posterior lumbar interbody fusion with double expandable peek cages without pedicle screw support for lumbar disc herniation.

OBJECTIVES: Posterior lumbar interbody fusion (PLIF) is usually bilateral procedure, and it is combined with posterior by bilateral pedicle screw support or with fixation. The purpose of this retrospective study was to compare the surgical outcomes of simple discectomy and PLIF without pedicle screw support in patients with lumbar disc herniation (LDH). PATIENTS AND METHODS: 60 patients with single segment LDH were operated between February 2010 and June 2013. 40 patients were treated with simple discectomy (Group 1) and 20 patients were treated with PLIF using double expandable polyetheretherketone (PEEK) cages without instrumentation (Group 2) unilaterally. Pain and function were evaluated by the visual analog scale (VAS) and Oswestry disability index (ODI) before and 18 months after surgery. Besides, PLIF patients were evaluated with computerized tomography (CT) scan of lumbar vertebra for the evaluation of the height of the disc, instability and fusion. RESULTS: Both leg and low back pain VAS scores were significantly improved 18 months after surgery in both of the groups (p<0.001). Significant decrease in VAS low back pain scores was seen in group 2 when compared to group 1 (p<0.001). Height of the intervertebral disc space was preserved and no instability was detected in group 2. No recurrence and 80% fusion rate was achieved in group 2. CONCLUSION: This study showed that unilateral PLIF intervention with double expandable PEEK cages without pedicle screw support would be sufficient in the management of single segment lumbar disc herniation in patients whom are thought to have lumbar stabilization.

A modified percutaneous transforaminal endoscopic surgery for central calcified thoracic disc herniation at the T11/T12 level using foraminoplasty and decompression: A case report.

Background: Thoracic disc herniation (TDH) is uncommon. Central calcified TDH (CCTDH) is even rare. Traditional open surgery was considered a gold standard to treat CCTDH, but it was accompanied by a high risk of complications. Recently, a technique called percutaneous transforaminal endoscopic decompression (PTED) was adopted to treat TDH. Gu et al. designed a simplified PTED technique and named it percutaneous transforaminal endoscopic surgery (PTES) to treat various types of lumbar disc herniation; it offered the advantages of simple orientation, easy puncture, reduced steps, and little x-ray exposure. However, PTES to treat CCTDH has not been reported in the literature. Methods: Here, we describe the case of a patient with CCTDH treated with a modified PTES through the unilateral posterolateral approach under local anesthesia and conscious sedation by using a flexible power diamond drill. First, we report that the patient was treated with PTES with later-stage endoscopic foraminoplasty, with an inside-out technique employed at the initial endoscopic decompression stage. Results: A 50-year-old male with progressive gait disturbance and bilateral leg rigidity with paresis and numbness was diagnosed with CCTDH at the T11/T12 level on MRI and CT examinations. A modified PTES was performed on November 22, 2019. The total mJOA (modified Japanese Orthopedic Association) score preoperatively was 12. The method of the determination of incision and the soft tissue trajectory establishment process were the same as those in the original PTES technique. The foraminoplasty process was divided into initial fluoroscopic and final endoscopic stages. At the fluoroscopic stage, the hand trephine's saw teeth were just rotated into the lateral portion of the ventral bone from the superior articular process (SAP) to seize the SAP firmly, while at the endoscopic stage, in order to remove the ventral bone from the SAP safely under direct endoscopic visualization, adequate foramen enlargement was achieved without causing any risk of damage to the neural structures in the spinal canal. During the endoscopic decompression process, the soft disc fragments ventral to the calcified shell were undermined to form a cavity using an inside-out technique. Then, a flexible endoscopic diamond burr was introduced to degrade the calcified shell, and a curved dissector or a flexible radiofrequency probe was used to dissect the thin bony shell from the dural sac. Eventually, the shell was fractured within the cavity piece by piece to remove the whole CCTDH and achieve adequate dural sac decompression, resulting in minimal blood loss and no complications. The symptoms were gradually alleviated and the patient almost completely recovered at the 3-month follow-up, with no symptom recurrence found at the 2-year follow-up. The mJOA score improved to 17 at the 3-month follow-up and to 18 at the 2-year follow-up compared with 12 points preoperatively. Conclusions: A modified PTES may be an alternative minimally invasive technique for the treatment of CCTDH and provide similar or better outcomes over traditional open surgery. However, this procedure requires good endoscopic experience on the part of the surgeon and is beset with technical challenges and therefore should be performed with utmost care.

A biomechanical testing method to assess tissue adhesives for annulus closure.

Intervertebral disc (IVD) degeneration has been linked to Low Back Pain (LBP) which affects over 80% of the population ranking first in terms of disability worldwide. Degeneration progresses with age and is often accompanied by annulus fibrosus (AF) tearing and nucleus pulposus (NP) herniation. Existing therapies fail to restore IVD function and may worsen AF defects, increasing the risk of reherniation in nearly 30% of patients. Current AF closure options are ineffective, presenting biological or mechanical limitations. Bioadhesives have potential use in this area, however methods to assess performance are limited. Herein, we propose a biomechanical testing method to assess bioadhesives' capacity to seal AF tears. Two candidate bioadhesives to seal AF tears were evaluated; a tough hydrogel adhesive, and a cyanoacrylate-based glue. The adhesion energy at the interface between bovine discs and the tough hydrogel adhesive was quantified using a peel test (n=4). An experimental method to measure the burst pressure of IVDs was then developed. This method was used to quantify the burst pressure of intact (n=7), injured (AF punctured with a 21G needle; n=7), and sealed IVDs (after applying either the tough hydrogel adhesive patch as a sealant; n=5, or the cyanoacrylate-based glue over the AF tear; n=6). The tough adhesive yielded a strong adhesion energy of 239 ± 49 J/m2 during the peel tests. A maximum pressure of 13.2 ± 3.8 MPa was observed for intact discs in the burst pressure tests, which reduced by 61.4% to 5.1 ± 1.5 MPa in the injured IVDs (p < 0.01)). Application of a cyanoacrylate-based glue to injured IVDs did not recover the burst pressure with statistical significance, however, application of the tough adhesive to injured IVDs, restored burst pressure to 12.3 ± 4.5 MPa, which was not significantly different to the intact burst pressures. In this study, a simple biomechanical method to assess the performance of bioadhesives to seal AF tears based upon burst pressure has been established. Using this method it was found that a tough hydrogel adhesive was able to seal an AF injury, such that the IVD burst pressures were similar to those measured in intact specimens. This method can be used to provide a biomechanical assessment of bioadhesives under high magnitude loading and can complement existing cyclic testing methods that are currently used to assess AF closure devices, improving their assessment before clinical use.

Biomaterials and Cell-Based Regenerative Therapies for Intervertebral Disc Degeneration with a Focus on Biological and Biomechanical Functional Repair: Targeting Treatments for Disc Herniation.

Intervertebral disc (IVD) degeneration is a common cause of low back pain and most spinal disorders. As IVD degeneration is a major obstacle to the healthy life of so many individuals, it is a major issue that needs to be overcome. Currently, there is no clinical treatment for the regeneration of degenerated IVDs. However, recent advances in regenerative medicine and tissue engineering suggest the potential of cell-based and/or biomaterial-based IVD regeneration therapies. These treatments may be indicated for patients with IVDs in the intermediate degenerative stage, a point where the number of viable cells decreases, and the structural integrity of the disc begins to collapse. However, there are many biological, biomechanical, and clinical challenges that must be overcome before the clinical application of these IVD regeneration therapies can be realized. This review summarizes the basic research and clinical trials literature on cell-based and biomaterial-based IVD regenerative therapies and outlines the important role of these strategies in regenerative treatment for IVD degenerative diseases, especially disc herniation.

Combination of stem cells from deciduous teeth and electroacupuncture for therapy in dogs with chronic spinal cord injury: A pilot study.

Spinal cord injury (SCI) is a serious condition that causes profound economic and emotional impact in human patients and companion animal owners. It has been shown that the neurogenic effects of the stem cells are enhanced when combined with electroacupuncture (EA) in rodent models of SCI. To determine the safety and feasibility of combining transplantation of allogenic stem cells derived from canine exfoliated deciduous teeth (SCED) and EA in dogs with chronic spinal cord injury a canine pilot clinical study was conducted. A total of 16 individuals ranging from 5 to 11 years at 3 to 18 months of injury were investigated and randomly assigned to 4 experimental groups (SCED, EA, SCED + EA, control). Mild neurological and functional improvements were seen in all 4 groups. There was no clinical progression or mortality of the cases occurred in a follow up of 7 months after procedure. The study shows that SCED transplantation and electroacupuncture were feasible, safe and potentially beneficial. However Long-term patient monitoring is necessary to rule out any delayed side effects and assess any further improvements.

Cell-Seeded Adhesive Biomaterial for Repair of Annulus Fibrosus Defects in Intervertebral Discs.

Defects in the annulus fibrosus (AF) of intervertebral discs allow nucleus pulposus tissue to herniate causing painful disability. Microdiscectomy procedures remove herniated tissue fragments, but unrepaired defects remain allowing reherniation or progressive degeneration. Cell therapies show promise to enhance repair, but methods are undeveloped and carriers are required to prevent cell leakage. To address this challenge, this study developed and evaluated genipin-crosslinked fibrin (FibGen) as an adhesive cell carrier optimized for AF repair that can deliver cells, match AF material properties, and have low risk of extrusion during loading. Part 1 determined that feasibility of bovine AF cells encapsulated in high concentration FibGen (F140G6: 140 mg/mL fibrinogen; 6 mg/mL genipin) for 7 weeks could maintain high viability, but had little proliferation or matrix deposition. Part 2 screened tissue mechanics and in situ failure testing of nine FibGen formulations (fibrin: 35-140 mg/mL; genipin: 1-6 mg/mL). F140G6 formulation matched AF shear and compressive properties and significantly improved failure strength in situ. Formulations with reduced genipin also exhibited satisfactory material properties and failure behaviors warranting further biological screening. Part 3 screened AF cells encapsulated in four FibGen formulations for 1 week and found that reduced genipin concentrations increased cell viability and glycosaminoglycan production. F70G1 (70 mg/mL fibrinogen; 1 mg/mL genipin) demonstrated balanced biological and biomechanical performance warranting further testing. We conclude that FibGen has potential to serve as an adhesive cell carrier to repair AF defects with formulations that can be tuned to enhance biomechanical and biological performance; future studies are required to develop strategies to enhance matrix production.

In vitro and biomechanical screening of polyethylene glycol and poly(trimethylene carbonate) block copolymers for annulus fibrosus repair.

Herniated intervertebral discs (IVDs) are a common cause of back and neck pain. There is an unmet clinical need to seal annulus fibrosus (AF) defects, as discectomy surgeries address acute pain but are complicated by reherniation and recurrent pain. Copolymers of polyethylene glycol with trimethylene carbonate (TMC) and hexamethylene diisocyanate (HDI) end-groups were formulated as AF sealants as the HDI form covalent bonds with native AF tissue. TMC adhesives were evaluated and optimized using the design criteria: stable size, strong adherence to AF tissue, high cytocompatibility, restoration of IVD biomechanics to intact levels following in situ repair, and low extrusion risk. TMC adhesives had high adhesion strength as assessed with a pushout test (150 kPa), and low degradation rates over 3 weeks in vitro. Both TMC adhesives had shear moduli (220 and 490 kPa) similar to, but somewhat higher than, AF tissue. The adhesive with three TMC moieties per branch (TMC3) was selected for additional in situ testing because it best matched AF shear properties. TMC3 restored torsional stiffness, torsional hysteresis area and axial range of motion to intact states. However, in a failure test of compressive deformation under fixed 5 ° flexion, some herniation risk was observed with failure strength of 5.9 MPa compared with 13.5 MPa for intact samples; TMC3 herniated under cyclic organ culture testing. These TMC adhesives performed well during in vitro and in situ testing, but additional optimization to enhance failure strength is required to further this material to advanced screening tests, such as long-term degradation. Copyright © 2016 John Wiley & Sons, Ltd.

[Effectiveness of combined Pregabalin and Celecoxib for treatment of neuropathic pain after percutaneous endoscopic lumbar discectomy].

Objective: To investigate the effectiveness of combined Pregabalin and Celecoxib for neuropathic pain after percutaneous endoscopic lumbar discectomy. Methods: Between January and June 2014, 178 patients with lumbar disc herniation underwent percutaneous endoscopic interlaminar discectomy (PEID). Ninety patients who met the inclusion criteria were recruited in this study. Every case in group A was recruited to match its counterpart in group B and group C according to gender, disease duration, herniated level, smoking history, preoperative Leeds assessment of neuropathic symptoms and signs (LANSS), and Oswestry disability index (ODI). Nine patients were excluded due to incomplete study or loss of follow-up. In each group, 27 cases were included in the final analysis. There was no significant difference in gender, age, height, body mass index, herniated level, disease duration, smoking history, preoperative LANSS, ODI, and visual analogue scale (VAS) between groups ( P>0.05). All patients of 3 groups received oral administration of Celecoxib from preoperative 3rd day to postoperative 14th day. Pregabalin was taken orally from preoperative 3rd day to postoperative 14th day in group A, and from postoperative 1st to 14th day in group B. Adverse drug reactions were observed during medication. The LANSS score and VAS score in rest state and active state were conducted before operation and at 1 day, 1 month, and 3 months after operation. ODI was conducted before operation and at 1, 3 months after operation. The number of neuropathic pain cases was recorded, and the effectiveness was evaluated by modified Macnab criteria at 3 months after operation. Results: During period of increasing Pregabalin dose, 1 patient of group A suffered severe dizziness, and 1 patient of group B suffered sleepiness, who were eliminated from this research. Another 2 cases (1 case of group A and 1 case of group C) suffered dry mouth, and 1 case of group B suffered muscle weakness. At 1 day after operation, the LANSS score and VAS in rest state and active state of group A were significantly lower than those of groups B and C ( P<0.05). At 1 month after operation, the LANSS score, ODI, and VAS in rest state and active state of group A and group B were significantly lower than those of group C ( P<0.05). At 3 months after operation, the LANSS score, ODI, and VAS in active state of group A and group B were significantly lower than those of group C ( P<0.05). There was no significant difference in the above indicators at the other time points between groups ( P>0.05). Neuropathic pain occurred at 3 months after operation in 1 case (3.7%) of group A and 6 cases (22.2%) of group C, showing significant differences in incidence of neuropathy pain between groups A, B and group C ( P<0.05), but no significant difference was found between group A and group B ( P>0.05). The excellent and good rate of modified Macnab criteria was 92.6% in group A, was 88.9% in group B, and was 85.2% in group C at 3 months after operation, showing no significant difference between groups ( P>0.05). Conclusion: Combined use of Pregabalin and Celecoxib during perioperative period can reduce postoperative pain and incidence of postoperative neuropathic pain. Preoperative oral Pregabalin can reduce the incidence of acute postoperative neuropathic pain.

Enhancing tissue repair in annulus fibrosus defects of the intervertebral disc: analysis of a bio-integrative annulus implant in an in-vivo ovine model.

Annulus fibrosus repair techniques for the intervertebral disc (IVD) address the unsolved problem of reherniation after IVD herniation and might facilitate the development of nucleus pulposus replacement techniques for IVD diseases. This study investigates the suitability of a bio-integrative annulus implant.Standardized box defects were applied to the annulus L3/4 and L4/5 of 16 sheep, followed by randomized insertion of the textile polyglycolic acid/polyvinylidene fluoride annulus implant in one of the defects. Explantation was conducted after 2, 6 and 12 weeks, followed by provocative pressure testing and histological analysis. At 2 weeks' follow-up, all specimens of the control defect group demonstrated uncontained herniated nucleus pulposus tissue in the annulus defects. For the treated specimens, the annulus implant consistently provided an effective barrier for herniating nucleus pulposus tissue, with no implant dislocation at all time-points. After 2 weeks, a homogeneous cell infiltration of the annulus implant was observed, leading to a progressive directional matrix build-up. Repair tissue thickness was significantly stronger with the annulus implant at all follow-ups (p < 0.01). No pronounced foreign body reaction and no difference in the amount of supra-annular scar tissue over the defect sites were observed. The implantation procedure inflicted annulus damage adjacent to the defect. At later time-points, however, no difference in comparison with the control defect group was evident. The investigated biointegrative annulus implant showed promising results with regard to biointegration, enhancement of repair tissue and function as a mechanical barrier in an ovine model.

Migration of fragments into the spinal canal after intervertebral polyethylene glycol implantation: an extremely rare adverse effect: Case report.

Percutaneous intervertebral hydrogel (polyethylene glycol) implantation is a current treatment procedure that aims to restore hydration of a degenerated disc. There have been a few studies that claim that polyethylene glycol is successful for pain relief as the intervertebral space restores its hydration and elasticity. This procedure is reported to be indicated for discogenic low-back pain and mild radicular pain as it contributes to disc restoration. In this report, the authors describe the case of a 43-year-old woman who was admitted with low-back and right leg pain. Muscle strength in dorsiflexion of the right ankle and right toe was 3/5. The patient had undergone hydrogel implantation for L4-5 intervertebral disc restoration 2 days prior to presentation. There was a significant increase in the patient's complaints after hydrogel implantation, and acute weakness in the right ankle and toe had developed. Magnetic resonance imaging of the lumbar vertebrae, which was performed before the hydrogel implantation, showed a significant narrowing of the L4-5 disc space height, and a disc herniation that extended to the right neural foramen and caused compression of the dural sac. The patient underwent surgery immediately. The sequestered disc fragment that caused a prominent stenosis in the spinal canal, as well as hydrogel fragments, was removed. There was an improvement in the patient's complaints and motor deficit postoperatively. In this paper, a very rare complication is reported. In patients who have increased pain after intervertebral hydrogel implantation and who develop a neurological deficit, the migration of the applied material into the spinal canal should be considered.

Protecting facet joints post-lumbar discectomy: Barricaid annular closure device reduces risk of facet degeneration.

Lumbar discectomy is an effective treatment for lumbar disc herniation (LDH). Although the majority of patients experience successful outcomes, a significant fraction will experience a recurrence of their back pain due to facet joint degeneration. Facet joint degeneration after discectomy may be the result of excessive nuclear removal, disc space narrowing, and annular injury. This study investigated whether implantation with the Barricaid annular closure device (ACD) during discectomy reduced the rate of facet degeneration. Inclusion criteria were primary lumbar disc herniation failing conservative treatment, Visual Analog Scale (VAS) Leg≥40/100, Oswestry Disability Index (ODI)≥40/100 and defects that were ≤60 mm2 (Barricaid arm only), and patient age 18-75. CT interpretations were collected preoperatively and 12 months post-discectomy. Patients implanted with Barricaid had significantly reduced rates and grades of facet degeneration than patients without Barricaid. Reinforcing the annulus fibrosus with Barricaid during lumbar discectomy may slow the progression of facet joint degeneration.