Abstract:
STUDY DESIGN:Pilot, single-center, single-blinded, parallel-group, randomized clinical study. OBJECTIVE:The aim of this study was to pilot a randomized clinical study to evaluate whether instrumented anterior lumbar interbody fusion (ALIF) with a new nanocrystalline hydroxyapatite embedded in a silica gel matrix (NH-SiO2) leads to superior radiologic and clinical outcomes at 12-month follow-up compared with instrumented ALIF with homologous bone. SUMMARY OF BACKGROUND DATA:ALIF completed with interbody cages is an established technique for performing arthrodesis of the lumbar spine. There is ongoing discussion about which cage-filling material is most appropriate. This is the first study to assess the efficacy of NH-SiO2 in ALIF surgery. MATERIALS AND METHODS:This randomized, clinical, pilot trial included 2 groups of 20 patients with monosegmental or multisegmental degenerative disease of the lumbar spine who were suitable to undergo monosegmental or bisegmental ALIF fusion at the level L4/L5 and L5/S1 with a carbon fiber reinforced polymer ALIF cage filled with either NH-SiO2 or homogenous bone. Primary outcome was postoperative disability as measured by the Oswestry Disability Index (ODI). Secondary outcomes were postoperative radiographic outcomes, pain, and quality of life. Patients were followed 12 months postoperatively. RESULTS:Mean (±SD) 12-month ODI was 24±17 in the NH-SiO2 group and 27±19 in the homologous bone group (P=0.582). Postoperative radiography, functional outcomes, and quality-of-life indices did not differ significantly between groups at any of the regularly scheduled follow-up visits. CONCLUSIONS:This clinical study showed similar functional, radiologic, and clinical outcomes 12 months postoperatively for instrumented ALIF procedures with the use of NH-SiO2 or homologous bone as cage filling. In the absence of any relevant differences in outcome, we postulate that the pivotal clinical study should be designed as an equivalence trial.
journal_name
Clin Spine Surgjournal_title
Clinical spine surgeryauthors
Rickert M,Fleege C,Papachristos I,Makowski MR,Rauschmann M,Arabmotlagh Mdoi
10.1097/BSD.0000000000000802subject
Has Abstractpub_date
2019-08-01 00:00:00pages
E319-E325issue
7eissn
2380-0186issn
2380-0194journal_volume
32pub_type
杂志文章,随机对照试验abstract:STUDY DESIGN:This was a narrative review. OBJECTIVE:This study aimed to review the current literature on surgical simulation in orthopedics and its application to spine surgery. SUMMARY OF BACKGROUND DATA:As orthopedic surgery increases in complexity, training becomes more relevant. There have been mandates in the Un...
journal_title:Clinical spine surgery
pub_type: 杂志文章
doi:10.1097/BSD.0000000000001070
更新日期:2020-10-09 00:00:00
abstract:STUDY DESIGN:A retrospective cohort study. OBJECTIVE:To examine the association between the American Society of Anesthesiologists (ASA) score and patient-reported outcomes (PROs) after minimally invasive transforaminal lumbar interbody fusion (MIS TLIF). SUMMARY OF BACKGROUND DATA:Few studies have investigated the co...
journal_title:Clinical spine surgery
pub_type: 杂志文章
doi:10.1097/BSD.0000000000000930
更新日期:2020-02-01 00:00:00
abstract:STUDY DESIGN:This is a retrospective comparative review. OBJECTIVE:The objective of this study was to identify the influence of body mass index (BMI) on postsurgical complications and patient reported outcomes measures (PROMs) following lumbar decompression surgery. SUMMARY OF BACKGROUND DATA:Current literature does ...
journal_title:Clinical spine surgery
pub_type: 杂志文章
doi:10.1097/BSD.0000000000001001
更新日期:2020-12-01 00:00:00
abstract:STUDY DESIGN:Open-label laboratory investigational study; non-animal surgical simulation. OBJECTIVE:The authors perform a comparison of dural closure strength in a durotomy simulator across 2 different suture materials. SUMMARY OF BACKGROUND DATA:Incidental durotomy leading to persistent cerebrospinal fluid leak adds...
journal_title:Clinical spine surgery
pub_type: 杂志文章
doi:10.1097/BSD.0000000000000169
更新日期:2017-07-01 00:00:00
abstract:STUDY DESIGN:Observational study. OBJECTIVES:The objectives of this study are (1) to quantify social media use among active American Cervical Spine Research Society (CSRS) members; (2) to determine if there is an association between practice setting, region, or years of active membership and social media use. SUMMARY...
journal_title:Clinical spine surgery
pub_type: 杂志文章
doi:10.1097/BSD.0000000000001127
更新日期:2021-01-04 00:00:00
abstract::Randomized clinical trials often represent the highest level of clinical evidence available to evaluate the efficacy of an intervention in clinical medicine. Although the process of randomization serves to maximize internal validity, the external validity, or generalizability, of such studies depends on several factor...
journal_title:Clinical spine surgery
pub_type: 杂志文章
doi:10.1097/BSD.0000000000000588
更新日期:2017-11-01 00:00:00
abstract:STUDY DESIGN:This was a national database study. OBJECTIVE:The objective of this study was to assess the impact of prior bariatric surgery (BS) on altering 90-day postoperative outcomes following elective anterior cervical discectomy and fusions (ACDFs). SUMMARY OF BACKGROUND DATA:Though obesity has previously been s...
journal_title:Clinical spine surgery
pub_type: 杂志文章
doi:10.1097/BSD.0000000000001120
更新日期:2020-12-07 00:00:00
abstract:STUDY DESIGN:A retrospective 1-year cost-utility analysis. OBJECTIVE:To determine the cost-effectiveness of using recombinant human bone morphogenic protein (rhBMP-2) in addition to autograft for 1- and 2-level lumbar fusions. SUMMARY OF BACKGROUND DATA:rhBMP-2 has been studied extensively to identify its benefits, r...
journal_title:Clinical spine surgery
pub_type: 杂志文章
doi:10.1097/BSD.0000000000000079
更新日期:2016-02-01 00:00:00
abstract:STUDY DESIGN:This was a prospective study. OBJECTIVE:To determine patient awareness of surgeon-industry relationships, how these relationships affect patient perceptions of surgeons, and which relationships cause the greatest concern to patients. SUMMARY OF BACKGROUND DATA:The prevalence of orthopedic surgeon-industr...
journal_title:Clinical spine surgery
pub_type: 杂志文章
doi:10.1097/BSD.0000000000000915
更新日期:2020-04-01 00:00:00
abstract:STUDY DESIGN:This is a multicentered retrospective study. SUMMARY OF BACKGROUND DATA:Surgical correction for the adult spinal deformity (ASD) is effective but carries substantial risks for complications. The diverse pathologies of ASD make it difficult to determine the effect of advanced age on outcomes. OBJECTIVE:Th...
journal_title:Clinical spine surgery
pub_type: 杂志文章,多中心研究
doi:10.1097/BSD.0000000000000842
更新日期:2020-02-01 00:00:00
abstract:STUDY DESIGN:An observational prospective cohort study. OBJECTIVE:To investigate the influence of natural history on the recovery of patients with cervical spondylotic myelopathy (CSM) after anterior cervical decompression. SUMMARY OF BACKGROUND DATA:The natural history of CSM has not been clearly elucidated, it rema...
journal_title:Clinical spine surgery
pub_type: 杂志文章
doi:10.1097/BSD.0000000000000873
更新日期:2019-10-01 00:00:00
abstract:PURPOSE:A retro-odontoid pseudotumor that is not associated with rheumatoid arthritis or hemodialysis is clinically rare. The majority of surgeons select transoral resection as the surgical treatment, often followed by posterior fusion or posterior decompression and fusion. In contrast, some authors have reported succe...
journal_title:Clinical spine surgery
pub_type: 杂志文章
doi:10.1097/BSD.0b013e31829eb7e6
更新日期:2016-12-01 00:00:00
abstract::Microsoft Excel (MS Excel) is a commonly used program for data collection and statistical analysis in biomedical research. However, this program has many limitations, including fewer functions that can be used for analysis and a limited number of total cells compared with dedicated statistical programs. MS Excel canno...
journal_title:Clinical spine surgery
pub_type: 杂志文章
doi:10.1097/BSD.0000000000000382
更新日期:2016-06-01 00:00:00
abstract:STUDY DESIGN:Expansive pedicle screws (EPS) and polymethylmethacrylate-augmented pedicle screws (PMMA-PS) were inserted into osteoporotic synthetic bones, which were then tested by radiographic and biomechanical examinations. OBJECTIVE:To compare the stability of EPS and PMMA-PS with that of a conventional pedicle scr...
journal_title:Clinical spine surgery
pub_type: 杂志文章
doi:10.1097/BSD.0b013e31828bfc85
更新日期:2016-08-01 00:00:00
abstract:STUDY DESIGN:Prospective cohort study. OBJECTIVE:To determine whether comorbidities and demographics, identified preoperatively, can impact patient outcomes and satisfaction after lumbar spine surgery. SUMMARY OF BACKGROUND DATA:The surgical treatment of lower back pain does not always eliminate a patient's pain and ...
journal_title:Clinical spine surgery
pub_type: 杂志文章
doi:10.1097/BSD.0000000000000331
更新日期:2017-07-01 00:00:00
abstract:STUDY DESIGN:A prospective cohort study. OBJECTIVE:The objective of this study was to establish the correlation between radiographic spinopelvic parameters with objective biomechanical measures of function in patients with adult degenerative scoliosis (ADS). SUMMARY OF BACKGROUND DATA:Gait and balance analyses can pr...
journal_title:Clinical spine surgery
pub_type: 杂志文章
doi:10.1097/BSD.0000000000000939
更新日期:2020-02-01 00:00:00
abstract:STUDY DESIGN:Retrospective analysis of prospectively collected clinical data. OBJECTIVE:To assess the long-term outcome of patients with monosegmental L4/5 degenerative spondylolisthesis treated with the dynamic Dynesys device. SUMMARY OF BACKGROUND DATA:The Dynesys system has been used as a semirigid, lumbar dorsal ...
journal_title:Clinical spine surgery
pub_type: 杂志文章
doi:10.1097/BSD.0b013e318277ca7a
更新日期:2016-03-01 00:00:00
abstract:STUDY DESIGN:This study was an ambispective long-term cost-utility analysis with retrospective chart review and included the prospective completion of health questionnaires by patients. OBJECTIVE:This was a cost-utility analysis, comparing conservative treatment, discectomy, and discectomy with spinal fusion for patie...
journal_title:Clinical spine surgery
pub_type: 杂志文章
doi:10.1097/BSD.0000000000000797
更新日期:2019-06-01 00:00:00
abstract:STUDY DESIGN:A prospective study with historical controls. OBJECTIVES:To evaluate and compare the safety and effectiveness of recombinant human bone morphogenetic protein-2 (rhBMP-2) with allograft for anterior cervical discectomy and fusion (ACDF) in patients with symptomatic single-level cervical degenerative disk d...
journal_title:Clinical spine surgery
pub_type: 临床试验,杂志文章
doi:10.1097/BSD.0000000000000409
更新日期:2017-11-01 00:00:00
abstract::Meralgia paresthetica is a non-life-threatening neurological disorder characterized by numbness, tingling, and burning pain over the anterolateral thigh due to impingement of the lateral femoral cutaneous nerve. This disorder has been seen in patients with diabetes mellitus and obesity, but has also been observed in p...
journal_title:Clinical spine surgery
pub_type: 杂志文章,评审
doi:10.1097/BSD.0000000000000593
更新日期:2018-03-01 00:00:00
abstract:STUDY DESIGN:A prospective study and a technique note. OBJECTIVES:To introduce a new entrance technique for C2 pedicle screw placement and to measure the related linear and angular parameters about the entrance point on computed tomography (CT) images. The safety of this technique for patients with atlantoaxial instab...
journal_title:Clinical spine surgery
pub_type: 临床试验,杂志文章
doi:10.1097/BSD.0000000000000164
更新日期:2017-06-01 00:00:00
abstract:STUDY DESIGN:Case series. OBJECTIVE:To evaluate radiographic and clinical outcomes of adults with spinal deformity treated with multilevel anterior column releases (ACR). SUMMARY OF BACKGROUND DATA:Pedicle subtraction osteotomy can be used effectively to correct spinal deformity; however, it is not without complicati...
journal_title:Clinical spine surgery
pub_type: 杂志文章,评审
doi:10.1097/BSD.0000000000000377
更新日期:2016-05-01 00:00:00
abstract:STUDY DESIGN:A retrospective study. OBJECTIVE:To evaluate the results of posterior pedicle-screw fixation with transpedicular decompression in 21 cases of thoracic and thoracolumbar spinal tuberculosis (TB) in terms of functional, neurological, and radiologic outcomes. SUMMARY OF BACKGROUND DATA:Spinal TB is predomin...
journal_title:Clinical spine surgery
pub_type: 杂志文章
doi:10.1097/BSD.0000000000000498
更新日期:2017-12-01 00:00:00
abstract::Spinal surgery has been revolutionized by advances in instrumentation, bone graft substitutes, and perioperative care. Extensive dissection, creation of large areas of dead space, and the use of instrumentation in compromised patients, however, predisposes to high rates of wound complications. Postoperative wound comp...
journal_title:Clinical spine surgery
pub_type: 杂志文章,评审
doi:10.1097/BSD.0000000000000936
更新日期:2020-02-01 00:00:00
abstract:STUDY DESIGN:This was a retrospective analysis of prospectively collected data. OBJECTIVE:To investigate the incidence of thromboembolism in patients who received tranexamic acid (TXA) after lumbar spine fusion and determine the diagnostic value of lower limb duplex sonography as a screening test. SUMMARY OF BACKGROU...
journal_title:Clinical spine surgery
pub_type: 杂志文章
doi:10.1097/BSD.0000000000000860
更新日期:2020-03-01 00:00:00
abstract:STUDY DESIGN:This was a cross-sectional study. OBJECTIVE:The objective of this study is to report the impact of COVID-19 on spine surgery fellow education and readiness for practice. SUMMARY OF BACKGROUND DATA:COVID-19 has emerged as one of the most devastating global health crises of our time. To minimize transmissi...
journal_title:Clinical spine surgery
pub_type: 杂志文章
doi:10.1097/BSD.0000000000001073
更新日期:2020-10-02 00:00:00
abstract:STUDY DESIGN:This study was a retrospective radiographic analysis of consecutive patients. OBJECTIVES:To analyze exposure to radiation of the surgeon and-separately-of patients in minimally invasive surgery (MIS) of multilevel posterior stabilization by percutaneous pedicle screw insertion guided by navigation (PIN) v...
journal_title:Clinical spine surgery
pub_type: 杂志文章
doi:10.1097/BSD.0000000000000807
更新日期:2019-06-01 00:00:00
abstract:STUDY DESIGN:This is a retrospective, self-controlled cohort study, at a single center. OBJECTIVE:The aim of this study was to evaluate the long-term outcome of sexual function after surgical treatment of single-level lumbar disk herniation (LDH). SUMMARY OF BACKGROUND DATA:The impact of surgical treatment on sexual ...
journal_title:Clinical spine surgery
pub_type: 杂志文章
doi:10.1097/BSD.0000000000000669
更新日期:2018-10-01 00:00:00
abstract:STUDY DESIGN:Prospective study. OBJECTIVE:To assess whether rib hump is a prognostic factor of final thoracic Cobb angle. SUMMARY OF BACKGROUND DATA:Correction of thoracolumbar/lumbar curve, preoperative thoracic curves angle, thoracic curves angle on bending, the thoracolumbar-lumbar angle/thoracic curves angle rati...
journal_title:Clinical spine surgery
pub_type: 杂志文章
doi:10.1097/BSD.0000000000000590
更新日期:2018-03-01 00:00:00
abstract::As the cost of health care continues to rise, government and commercial payors are implementing strategies as a means of reducing the overall expenditure of health care dollars. The largest savings will be not just in more cost-effective treatments but in strategies that can avoid the need for treatments in the first ...
journal_title:Clinical spine surgery
pub_type: 杂志文章
doi:10.1097/BSD.0000000000000541
更新日期:2018-10-01 00:00:00