The NEtherlands Cervical Kinematics (NECK) Trial. Cost-effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in the treatment of cervical disc herniation; a double-blind randomised multicenter study

Background. Patients with cervical radicular syndrome due to disc herniation refractory to conservative treatment are offered surgical treatment. Anterior cervical discectomy is the standard procedure, often in combination with interbody fusion. Accelerated adjacent disc degeneration is a known entity on the long term. Recently, cervical disc prostheses are developed to maintain motion and possibly reduce the incidence of adjacent disc degeneration. A comparative cost-effectiveness study focused on adjacent segment degeneration and functional outcome has not been performed yet. We present the design of the NECK trial, a randomised study on cost-effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in patients with cervical disc herniation. Methods/Design. Patients (age 18-65 years) presenting with radicular signs due to single level cervical disc herniation lasting more than 8 weeks are included. Patients will be randomised into 3 groups: anterior discectomy only, anterior discectomy with interbody fusion, and anterior discectomy with disc prosthesis. The primary outcome measure is symptomatic adjacent disc degeneration at 2 and 5 years after surgery. Other outcome parameters will be the Neck Disability Index, perceived recovery, arm and neck pain, complications, re-operations, quality of life, job satisfaction, anxiety and depression assessment, medical consumption, absenteeism, and costs. The study is a randomised prospective multicenter trial, in which 3 surgical techniques are compared in a parallel group design. Patients and research nurses will be kept blinded of the allocated treatment for 2 years. The follow-up period is 5 years. Discussion. Currently, anterior cervical discectomy with fusion is the golden standard in the surgical treatment of cervical disc herniation. Whether additional interbody fusion or disc prothesis is necessary and cost-effective will be determined by this trial. Trial Registration. Netherlands Trial Register NTR1289

Timing of surgery for sciatica: subgroup analysis alongside a randomized trial

Surgery speeds up recovery for sciatica. Prolonged conservative care with surgery for those patients with persistent sciatica however, yields similar results at 1 year. To investigate whether baseline variables modify the difference in recovery rates between these treatment strategies, baseline data of 283 patients enrolled in a randomized trial, comparing early surgery with prolonged conservative care, were used to analyse effect modification of the allotted treatment strategy. For predictors shown to modify the effect of the treatment strategy, repeated measurement analyses with the Roland Disability Questionnaire and visual analogue scale pain as continuous outcomes were performed for every level of that predictor. Presumed predictive variables did not have any interaction with treatment, while “sciatica provoked by sitting” showed to be a significant effect modifier (P = 0.07). In a Cox model we estimated a hazard ratio (HR, surgery versus conservative) of 2.2 (95% CI 1.7–3.0) in favour of surgery when sciatica was provoked by sitting, while the HR was 1.3 (95% CI 0.8–2.2) when this sign was absent. The interaction effect is marginally significant (interactions are usually tested at the 10% level) but the patterns generated by the repeated measurement analyses of all primary outcomes are completely consistent with the inferred pattern from the survival analysis. Classical signs did not show any contribution as decision support tools in deciding when to operate for sciatica, whereas treatment effects of early surgery are emphasized when sciatica is provoked by sitting and negligible when this symptom is absent

Clinical outcome in decompression alone versus decompression and instrumented fusion in patients with isthmic spondylolisthesis:A prospective cohort study

OBJECTIVE In the surgical treatment of isthmic spondylolisthesis, it is debatable whether instrumented fusion is mandatory in addition to decompression. The objective of this prospective cohort study was to assess the long-term effect of decompression alone compared with decompression and instrumented fusion in patients who underwent the intervention of their own preference. The results were compared with those in patients who underwent randomly assigned treatment. METHODS The authors performed a prospective observational multicenter cohort study, including 91 patients with isthmic spondylolisthesis assigned to undergo either decompression alone (n = 44) or decompression and fusion (n = 47). The main outcomes were the Roland-Morris Disability Questionnaire (RDQ) scores and the patient's perceived recovery at the 2-year follow-up. Secondary outcomes were visual analog scale (VAS) leg pain and back pain scores and the reoperation rate. A meta-analysis was performed for data from this cohort study (n = 91) and from a randomized controlled trial (RCT) previously reported by the authors (n = 84). Subgroup analyses were performed on these combined data for age, sex, weight, smoking, and Meyerding grade. RESULTS At the 12-week follow-up, improvements of RDQ scores were comparable for the two procedures (decompression alone [D group] 4.4, 95% CI 2.3-6.5; decompression and fusion [DF group] 5.8, 95% CI −4.3 to 1.4; p = 0.31). Likewise, VAS leg pain scores (D group 35.0, 95% CI 24.5-45.6; DF group 47.5, 95% CI 37.4-57.5; p = 0.09) and VAS back pain scores (D group 23.5, 95% CI 13.3-33.7; DF group 34.0, 95% CI 24.1-43.8; p = 0.15) were comparable. At the 2-year follow-up, there were no significant differences between the two groups in terms of scores for RDQ (difference −3.1, 95% CI −6.4 to 0.3, p = 0.07), VAS leg pain (difference −7.4, 95% CI −22.1 to 7.2, p = 0.31), and VAS back pain (difference −11.4, 95% CI −25.7 to 2.9, p = 0.12). In contrast, patient-perceived recovery from leg pain was significantly higher in the DF group (79% vs 51%, p = 0.02). Subgroup analyses did not demonstrate a superior outcome for decompression alone compared with decompression and fusion. Nine patients (20.5%) underwent reoperation in total, all in the D group. The meta-analysis including both the cohort and RCT populations yielded an estimated pooled mean difference in RDQ of −3.7 (95% CI −5.94 to −1.55, p = 0.0008) in favor of decompression and fusion at the 2-year follow-up. CONCLUSIONS In patients with isthmic spondylolisthesis, at the 2-year follow-up, patients who underwent decompression and fusion showed superior functional outcome and perceived recovery compared with those who underwent decompression alone. No subgroups benefited from decompression alone. Therefore, decompression and fusion is recommended over decompression alone as a primary surgical treatment option in isthmic spondylolisthesis.</p

Conservative treatment in patients with an acute lumbosacral radicular syndrome: design of a randomised clinical trial [ISRCTN68857256]

BACKGROUND: The objective is to present the design of randomised clinical trial (RCT) on the effectiveness of physical therapy added to general practitioners management compared to general practitioners management only in patients with an acute lumbosacral radicular syndrome (also called sciatica). METHODS/DESIGN: Patients in general practice diagnosed with an acute (less than 6 weeks) lumbosacral radicular syndrome and an age above 18 years are eligible for participation. The general practitioners treatment follows their clinical guideline. The physical therapy treatment will consist of patient education and exercise therapy. The primary outcome measure is patients reported global perceived effect. Secondary outcome measures are severity of complaints, functional status, health status, fear of movement, medical consumption, sickness absence, costs and treatment preference. The follow-up is 52 weeks. DISCUSSION: Treatment by general practitioners and physical therapists in this study will be transparent and not a complete "black box". The results of this trial will contribute to the decision of the general practitioner regarding referral to physical therapy in patients with an acute lumbosacral radicular syndrome

Chronic subdural hematoma:A variable clinical picture that asks for tailored treatment

A chronic subdural hematoma is a common neurological disorder that occurs mainly in the elderly. The inciting event is often a minor head trauma and subsequent inflammation may play a role in the pathogenesis. The clinical spectrum can present heterogeneously, and symptom onset and progression can vary from days to weeks. To date surgical evacuation of the subdural collection remains the main treatment approach for symptomatic patients. Evidence is still scarce for dexamethasone as an effective primary conservative treatment strategy. Future research is necessary to elucidate the effect of various pharmacological therapies compared to primary surgery on functional outcome

Influence of severity and level of injury on the occurrence of complications during the subacute and chronic stage of traumatic spinal cord injury:a systematic review

Objective: Secondary health conditions (SHCs) are long-term complications that frequently occur due to traumatic spinal cord injury (tSCI) and can negatively affect quality of life in this patient population. This study provides an overview of the associations between the severity and level of injury and the occurrence of SHCs in tSCI. Methods: A systematic search was conducted in PubMed and Embase that retrieved 44 studies on the influence of severity and/or level of injury on the occurrence of SHCs in the subacute and chronic phase of tSCI (from 3 months after trauma). The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. Results: In the majority of studies, patients with motor-complete tSCI (American Spinal Injury Association [ASIA] Impairment Scale [AIS] grade A or B) had a significantly increased occurrence of SHCs in comparison to patients with motor-incomplete tSCI (AIS grade C or D), such as respiratory and urogenital complications, musculoskeletal disorders, pressure ulcers, and autonomic dysreflexia. In contrast, an increased prevalence of pain was seen in patients with motor-incomplete injuries. In addition, higher rates of pulmonary infections, spasticity, and autonomic dysreflexia were observed in patients with tetraplegia. Patients with paraplegia more commonly suffered from hypertension, venous thromboembolism, and pain. Conclusions: This review suggests that patients with a motor-complete tSCI have an increased risk of developing SHCs during the subacute and chronic stage of tSCI in comparison with patients with motor-incomplete tSCI. Future studies should examine whether systematic monitoring during rehabilitation and the subacute and chronic phase in patients with motor-complete tSCI could lead to early detection and potential prevention of SHCs in this population

UJI AKTIVITAS PROTEASE DAN KARAKTERISASI PH ACTINOMYCETES ISOLAT ATH-03 ASAL TAHURA POCUT MEURAH INTAN KABUPATEN ACEH BESAR

ABSTRAKKata kunci: Aktivitas Protease, Karakterisasi pH, Actinomycetes.Penelitian Uji Aktivitas Protease dan Karakterisasi pH Actinomycetes Isolat ATH-03 Asal Tahura Pocut Meurah Intan Kabupaten Aceh Besar telah dilaksanakan sejak tanggal 3 September sampai dengan 27 Desember 2012. Penelitian ini bertujuan untuk mengukur aktivitas protease dan mengetahui pH optimum aktivitas protease dari isolat Actinomycetes ATH-03. Metode penelitian yang digunakan adalah metode Eksperimen dengan Rancangan Acak Lengkap Non Faktorial dengan 6 kali perlakuan, 2 kali ulangan. Data yang diperoleh dianalisis secara deskriptif yang terkait dengan nilai indeks proteolitik sebagai dasar seleksi isolat Actinomycetes. Isolat Actinomycetes berasal dari koleksi Laboratorium Mikrobiologi Jurusan Biologi FMIPA Universitas Syiah Kuala. Delapan belas isolat Actinomycetes menunjukkan aktivitas pada Media NA yang mengandung susu skim 1%. Isolat ATH-03 dipilih dalam penelitian ini karena memiliki zona bening yang lebar dengan indeks proteolitik (IP) tertinggi 8,537 setelah inkubasi selama 48 jam pada Media NAS. Protease ekstraseluler dikarakterisasi menggunakan media NB yang mengandung susu skim 1% sebagai media produksi. Waktu optimum pemanenan ekstrak kasar protease isolat ATH-03 pada hari ke-7 dengan aktivitas sebesar 0,083 U/ml, kadar protein 0,003 mg/ml dan aktivitas spesifik mencapai 23,72 U/mg. Hasil karakterisasi pH ekstrak kasar enzim isolat ATH-03 menunjukkan aktivitas optimum pada pH 8 yaitu 0,067 U/ml, protease yang dihasilkan oleh isolat ini aktif pada kisaran pH netral.Banda Ace

Timing and minimal access surgery for sciatica: a summary of two randomized trials

Scientific Assessment and Innovation in Neurosurgical Treatment Strategie