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  1. Article: Salvage of Failed Lateral Sacroiliac Joint Fusion with a Novel Posterior Sacroiliac Fusion Device: Diagnostic Approach, Surgical Technique, and Multicenter Case Series.

    Sayed, Dawood / Khatri, Nasir / Rupp, Adam / Bovinet, Christopher / Azeem, Nomen / Li, Sean / Josephson, Youssef / Pope, Jason

    Journal of pain research

    2022  Volume 15, Page(s) 1411–1420

    Abstract: Background: Studies have found that up to one-third of patients with LBP have sacroiliac joint (SIJ) dysfunction as a contributing cause. Historically, the management of SIJ dysfunction has been plagued by ineffectiveness or significant morbidity. In ... ...

    Abstract Background: Studies have found that up to one-third of patients with LBP have sacroiliac joint (SIJ) dysfunction as a contributing cause. Historically, the management of SIJ dysfunction has been plagued by ineffectiveness or significant morbidity. In 2008, minimally invasive lateral SIJ fusion was developed. While this procedure is a safe and effective treatment, there is still a significant proportion of patients who will not experience therapeutic success. There is a paucity of data in the literature regarding the management of these patients. Recently, a novel posterior sacroiliac joint fusion device has been developed which minimizes complications compared to lateral approaches and may serve to salvage therapeutic failures in this patient population.
    Objective: Determine the efficacy and feasibility of a posterior SIJ fusion device as a salvage technique in patients who have not experienced therapeutic success following lateral SIJ fusion.
    Design: Multi-center retrospective observational study.
    Methods: Patients who had previously undergone lateral SIJ fusion and had persistent LBP were evaluated and diagnosed to have persistent primary SIJ pathology. All patients underwent posterior SIJ fusion utilizing a machined allograft transfixing sacroiliac fusion device. Demographic data and patient reported pain scores were collected.
    Results: A total of 7 patients who had undergone lateral SIJ fusion were included in the study and underwent posterior SIJ fusion. The mean patient reported pain improvement following posterior fusion was 80% with an average follow-up time of 10 months. Median morphine milliequivalents were 20 pre-procedure and 0 post-procedure.
    Conclusion: We were able to show significant reductions in pain scores and opioid consumption, which suggests that minimally invasive posterior SIJ utilizing a novel implant and technique may be a viable treatment option to salvage pain relief in this patient population. Further, the favorable safety profile of this posterior technique uniquely positions it to be an appropriate first-line surgical therapy.
    Language English
    Publishing date 2022-05-12
    Publishing country New Zealand
    Document type Case Reports
    ZDB-ID 2495284-9
    ISSN 1178-7090
    ISSN 1178-7090
    DOI 10.2147/JPR.S357076
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Safety, Efficacy, and Durability of Outcomes: Results from SECURE: A Single Arm, Multicenter, Prospective, Clinical Study on a Minimally Invasive Posterior Sacroiliac Fusion Allograft Implant.

    Calodney, Aaron / Azeem, Nomen / Buchanan, Patrick / Skaribas, Ioannis / Antony, Ajay / Kim, Christopher / Girardi, George / Vu, Chau / Bovinet, Christopher / Vogel, Rainer / Li, Sean / Jassal, Navdeep / Josephson, Youssef / Lubenow, Timothy / Lam, Christopher M / Deer, Timothy R

    Journal of pain research

    2024  Volume 17, Page(s) 1209–1222

    Abstract: Introduction: Research suggests that sacroiliac joint (SIJ) dysfunction is responsible for 15% to 30% of reported low back pain cases. Recently, there has been an increasing interest in SIJ fusion using minimally invasive surgery (MIS) due to safety. ... ...

    Abstract Introduction: Research suggests that sacroiliac joint (SIJ) dysfunction is responsible for 15% to 30% of reported low back pain cases. Recently, there has been an increasing interest in SIJ fusion using minimally invasive surgery (MIS) due to safety. Initially, devices designed for MIS were intended for lateral approaches. A minimally invasive sacroiliac fusion implant for use with a posterior approach has been developed and is regulated for clinical use under the regulatory framework required for human cells, tissues, or cellular or tissue-based products (HCT/Ps).
    Methods: A multi-center, prospective, single-arm study was launched after initial studies provided preliminary data to support safety, efficacy, and durability of this minimally invasive sacroiliac posterior fusion LinQ allograft implant (NCT04423120). Preliminary results were reported previously. Final results for the full participant cohort are presented here.
    Results: One-hundred and fifty-nine (159) participants were enrolled across 16 investigational sites in the US between January 2020 and March 2022. One-hundred and twenty-two (122) participants were implanted. At the 1-month follow-up, 82 participants satisfied all criteria for the composite responder endpoint, representing 73.2% of the study cohort. These results stayed consistent across the remaining study timepoints with 66.0%, 74.4%, and 73.5% of participants classified as responders at the 3-, 6- and 12-month follow-up visits, respectively. VAS scores were significantly reduced (p < 0.0001) and ODI scores were significantly improved (p < 0.0001). All domains of the PROMIS-29 were also significantly improved (all p's <0.0001). Only one procedure-related serious AE was reported in the study.
    Conclusion: These results suggest that the posterior approach LinQ Implant System is a safe and effective treatment for sacroiliac joint dysfunction at 12 months, with results that are favorable compared to outcomes reported for an FDA-cleared lateral approach.
    Language English
    Publishing date 2024-03-20
    Publishing country New Zealand
    Document type Journal Article
    ZDB-ID 2495284-9
    ISSN 1178-7090
    ISSN 1178-7090
    DOI 10.2147/JPR.S458334
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: A Review of Lumbar Spinal Stenosis with Intermittent Neurogenic Claudication: Disease and Diagnosis.

    Deer, Timothy / Sayed, Dawood / Michels, John / Josephson, Youssef / Li, Sean / Calodney, Aaron K

    Pain medicine (Malden, Mass.)

    2019  Volume 20, Issue Suppl 2, Page(s) S32–S44

    Abstract: Objective: Lumbar spinal stenosis (LSS) is a degenerative spinal condition affecting nearly 50% of patients presenting with lower back pain. The goal of this review is to present and summarize the current data on how LSS presents in various populations, ...

    Abstract Objective: Lumbar spinal stenosis (LSS) is a degenerative spinal condition affecting nearly 50% of patients presenting with lower back pain. The goal of this review is to present and summarize the current data on how LSS presents in various populations, how it is diagnosed, and current therapeutic strategies. Properly understanding the prevalence, presentation, and treatment options for individuals suffering from LSS is critical to providing patients the best possible care.
    Results: The occurrence of LSS is associated with advanced age. In elderly patients, LSS can be challenging to identify due to the wide variety of presentation subtleties and common comorbidities such as degenerative disc disease. Recent developments in imaging techniques can be useful in accurately identifying the precise location of the spinal compression. Treatment options can range from conservative to surgical, with the latter being reserved for when patients have neurological compromise or conservative measures have failed. Once warranted, there are several surgical techniques at the physician's disposal to best treat each individual case.
    MeSH term(s) Back Pain/complications ; Back Pain/surgery ; Decompression, Surgical/methods ; Humans ; Intermittent Claudication/surgery ; Low Back Pain/complications ; Lumbar Vertebrae/surgery ; Spinal Stenosis/complications ; Spinal Stenosis/diagnosis ; Spinal Stenosis/surgery
    Language English
    Publishing date 2019-11-20
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Review
    ZDB-ID 2015903-1
    ISSN 1526-4637 ; 1526-2375
    ISSN (online) 1526-4637
    ISSN 1526-2375
    DOI 10.1093/pm/pnz161
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Six Month Interim Outcomes from SECURE: A Single arm, Multicenter, Prospective, Clinical Study on a Novel Minimally Invasive Posterior Sacroiliac Fusion Device.

    Calodney, Aaron K / Azeem, Nomen / Buchanan, Patrick / Skaribas, Ioannis / Antony, Ajay / Kim, Christopher / Girardi, George / Vu, Chau / Bovinet, Christopher / Vogel, Rainer S / Li, Sean / Jassal, Naveep / Josephson, Youssef / Lubenow, Timothy R / Girardi, Nicholas / Pope, Jason E

    Expert review of medical devices

    2022  Volume 19, Issue 5, Page(s) 451–461

    Abstract: Introduction: Sacroiliac joint disease is a prominent diagnosis across the world. A novel fixation technique employing a posterior approach, single point, bone allograft transfixation has proven to be helpful anecdotally. The purpose of this is study is ...

    Abstract Introduction: Sacroiliac joint disease is a prominent diagnosis across the world. A novel fixation technique employing a posterior approach, single point, bone allograft transfixation has proven to be helpful anecdotally. The purpose of this is study is to investigate prospectively the safety and efficacy of this approach.
    Methods: A multicenter, prospective, single arm study was performed after patient identification and treatment with the novel posterior fusion, single-point transfixation system and followed for 24 months. Target enrollment is 100 patients. Interim results on the first 69 consecutive patients at 6 months is presented. Primary endpoint at 6-month analysis was Pain Intensity reduction by visual analogue scale and functional improvement by Oswestry Disability Index. Adverse events were assessed for safety analysis.
    Results: In total, 69 patients were identified for this analysis. At 6 months, a mean improvement of 34.9 was identified by a reduction in VAS and functional improvement was demonstrated by a mean reduction in ODI of 17.7. There were three adverse events, all unrelated to the device.
    Conclusion: The posterior single point transfixation is safe and efficacious for the treatment of sacroiliac joint dysfunction with statistical improvements in pain and function.
    MeSH term(s) Humans ; Low Back Pain/diagnosis ; Low Back Pain/surgery ; Pain Measurement ; Prospective Studies ; Sacroiliac Joint/surgery ; Spinal Fusion/methods ; Treatment Outcome
    Language English
    Publishing date 2022-07-18
    Publishing country England
    Document type Journal Article ; Multicenter Study
    ZDB-ID 2250857-0
    ISSN 1745-2422 ; 1743-4440
    ISSN (online) 1745-2422
    ISSN 1743-4440
    DOI 10.1080/17434440.2022.2090244
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Alternative approach to needle placement in cervical spinal cord stimulator insertion.

    Zhu, Jie / Falco, Frank J E / Onyewu, C Obi / Vesga, Renato / Josephson, Youssef / Husain, Asim / Gutman, Gabriella

    Pain physician

    2011  Volume 14, Issue 2, Page(s) 195–210

    Abstract: Background: Neuromodulation with spinal cord stimulation is a proven cost effective treatment for the management of common conditions such as chronic radicular leg pain from failed back surgery syndrome, complex regional pain syndrome, and other painful ...

    Abstract Background: Neuromodulation with spinal cord stimulation is a proven cost effective treatment for the management of common conditions such as chronic radicular leg pain from failed back surgery syndrome, complex regional pain syndrome, and other painful neuropathic pain syndromes. The traditionally instructed method for percutaneous spinal cord stimulator (SCS) lead placement promotes the use of a "loss of resistance" (LOR) technique under anteroposterior (AP) fluoroscopic guidance to assure midline lead placement and proper entry into the epidural space.
    Objective: To describe the relevant anatomy and method for a precise needle placement approach for placement of percutaneous cervical spinal cord stimulation (SCS) leads without loss of resistance (LOR) using a syringe. An oblique fluoroscopic view is presented demonstrating successful placement of cervical SCS leads.
    Design: Technical report.
    Setting: Pain management clinic.
    Methods: Discussion with accompanying fluoroscopic images. This technical report meets HIPAA compliance standards.
    Results: Successful placement of percutaneous SCS leads without traditional loss of resistance using an oblique fluoroscopic approach.
    Limitations: Technical report only. The risks, potential complications, and benefit from this approach are beyond the scope of the article.
    Conclusions: This fluoroscopic technique provides an alternative means for placing percutaneous cervical SCS leads without the use of the traditional loss of resistance technique.
    MeSH term(s) Cervical Vertebrae ; Electric Stimulation Therapy/instrumentation ; Electric Stimulation Therapy/methods ; Electrodes, Implanted ; Humans ; Neuralgia/therapy ; Spinal Cord/surgery
    Language English
    Publishing date 2011-03
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2146393-1
    ISSN 2150-1149 ; 1533-3159
    ISSN (online) 2150-1149
    ISSN 1533-3159
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article: Inhibition of 7,12-dimethylbenz[a]anthracene (DMBA)-induced oral carcinogenesis in hamsters by tea and curcumin.

    Li, Ning / Chen, Xiaoxin / Liao, Jie / Yang, Guangyu / Wang, Su / Josephson, Youssef / Han, Chi / Chen, Junshi / Huang, Mou-Tuan / Yang, Chung S

    Carcinogenesis

    2002  Volume 23, Issue 8, Page(s) 1307–1313

    Abstract: Tea is one of the most popular beverages consumed in the world. Curcumin, the major yellow pigment in turmeric, is used widely as a spice and food-coloring agent. In this study, we studied the effects of tea and curcumin on 7,12-dimethylbenz[a]anthracene ...

    Abstract Tea is one of the most popular beverages consumed in the world. Curcumin, the major yellow pigment in turmeric, is used widely as a spice and food-coloring agent. In this study, we studied the effects of tea and curcumin on 7,12-dimethylbenz[a]anthracene (DMBA)-induced oral carcinogenesis in hamsters. DMBA solution (0.5% in mineral oil, 0.1 ml) was applied topically to the left cheek pouch of male Syrian golden hamsters 3 times/week for 6 weeks. Two days after the last treatment of DMBA, the animals received green tea (6 mg tea solids/ml) as drinking fluid, or 10 mmol curcumin applied topically 3 times/week, or the combination of green tea and curcumin treatment, or no treatment for 18 weeks. The combination of tea and curcumin significantly decreased the oral visible tumor incidence from 92.3% (24/26) to 69.2% (18/26) and the squamous cell carcinoma (SCC) incidence from 76.9% (20/26) to 42.3% (11/26). The combination of tea and curcumin also decreased the number of visible tumors and the tumor volume by 52.4 and 69.8%, as well as the numbers of SCC, dysplasic lesions and papillomas by 62.0, 37.5 and 48.7%, respectively. Green tea or curcumin treatment decreased the number of visible tumors by 35.1 or 39.6%, the tumor volume by 41.6 or 61.3% and the number of SCC by 53.3 or 51.3%, respectively. Green tea also decreased the number of dysplasic lesions. Curcumin also significantly decreased the SCC incidence. Tea and curcumin, singly or in combination, decreased the proliferation index in hyperplasia, dysplasia and papillomas. Only the combination treatment decreased the proliferation index in SCC. Tea alone and in combination with curcumin significantly increased the apoptotic index in dysplasia and SCC. Curcumin, alone and in combination with tea, significantly inhibited the angiogenesis in papilloma and SCC. The results suggested that green tea and curcumin had inhibitory effects against oral carcinogenesis at the post-initiation stage and such inhibition may be related to the suppression of cell proliferation, induction of apoptosis and inhibition of angiogenesis.
    MeSH term(s) 9,10-Dimethyl-1,2-benzanthracene/antagonists & inhibitors ; 9,10-Dimethyl-1,2-benzanthracene/toxicity ; Animals ; Anticarcinogenic Agents/pharmacology ; Apoptosis ; Carcinogens/toxicity ; Cell Division ; Cricetinae ; Curcumin/pharmacology ; Male ; Mesocricetus ; Mouth Neoplasms/chemically induced ; Mouth Neoplasms/pathology ; Mouth Neoplasms/prevention & control ; Neovascularization, Pathologic ; Tea
    Chemical Substances Anticarcinogenic Agents ; Carcinogens ; Tea ; 9,10-Dimethyl-1,2-benzanthracene (57-97-6) ; Curcumin (IT942ZTH98)
    Language English
    Publishing date 2002-08
    Publishing country England
    Document type Journal Article ; Research Support, U.S. Gov't, P.H.S.
    ZDB-ID 603134-1
    ISSN 1460-2180 ; 0143-3334
    ISSN (online) 1460-2180
    ISSN 0143-3334
    DOI 10.1093/carcin/23.8.1307
    Database MEDical Literature Analysis and Retrieval System OnLINE

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