Clinical and Radiographic Outcomes in Patients Undergoing Single-level Anterior Cervical Arthrodesis: A Prospective Trial Comparing Allograft to a Reduced Dose of rhBMP-2.

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 disease. SUMMARY OF BACKGROUND DATA:rhBMP-2 is an osteoinductive protein that has been shown to induce fusion when used as an implant with a suitable carrier in spine surgery. However, some previous studies have shown rhBMP-2 use to be associated with a higher complication rate. METHODS:Investigational patients (224) with single-level cervical degenerative disk disease underwent ACDF with rhBMP-2 at a dose of 0.6 or 1.05 mg and were compared with historical control patients (486) treated with allograft spacer and cervical plate. RESULTS:At 24 months, improvement was significantly greater in the investigational group (37.1 points) than in the control group for Neck Disability Index (P=0.002) and arm pain (P=0.031). The overall neurological success rate was higher in the investigational group (P<0.001). Neck pain and general health status (SF-36 PCS and MCS) were similar. Fusion rate in the investigational group was higher than in the control group (99.4% vs. 87.2%, P=0.002).Cumulative adverse event rates at 24 months were similar; however, higher rates of dysphagia (P=0.001), local swelling (P=0.024), oropharyngeal pain (P=0.013), neck pain (P=0.019), and foraminal stenosis (P=0.002) were observed in the investigational group. Heterotopic ossification was also higher in the investigational group. CONCLUSIONS:At doses of 0.6 or 1.05 mg in a PEEK interbody cage, rhBMP-2 was effective in inducing fusion and improving Neck Disability Index and arm pain in single-level ACDF patients; however, higher rates of certain adverse events were observed in the investigational group. LEVEL OF EVIDENCE:Level 2.

journal_name

Clin Spine Surg

journal_title

Clinical spine surgery

authors

Burkus JK,Dryer RF,Arnold PM,Foley KT

doi

10.1097/BSD.0000000000000409

subject

Has Abstract

pub_date

2017-11-01 00:00:00

pages

E1321-E1332

issue

9

eissn

2380-0186

issn

2380-0194

journal_volume

30

pub_type

临床试验,杂志文章
  • Clinical and Radiographic Outcomes of C1 Laminectomy Without Fusion in Patients With Cervical Myelopathy That Is Associated With a Retro-odontoid Pseudotumor.

    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

    authors: Takemoto M,Neo M,Fujibayashi S,Sakamoto T,Ota M,Otsuki B,Kaneko H,Umebayashi T

    更新日期:2016-12-01 00:00:00

  • Navigation Versus Fluoroscopy in Multilevel MIS Pedicle Screw Insertion: Separate Analysis of Exposure to Radiation of the Surgeon and of the Patients.

    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

    authors: Konieczny MR,Krauspe R

    更新日期:2019-06-01 00:00:00

  • Modic Change and Clinical Assessment Scores in Patients Undergoing Lumbar Surgery for Disk Herniation.

    abstract:STUDY DESIGN:Retrospective cohort study. OBJECTIVE:To examine the relationship between preoperative Modic change (MC) and postoperative clinical assessment scores for patients receiving lumbar discectomy or transforaminal lumbar interbody fusion for lumbar disk herniation. SUMMARY OF BACKGROUND DATA:Lumbar disk herni...

    journal_title:Clinical spine surgery

    pub_type: 杂志文章

    doi:10.1097/BSD.0000000000001076

    authors: MacLean MA,Kureshi N,Shankar J,Stewart SA,Christie SD

    更新日期:2020-09-25 00:00:00

  • Evaluating Social Media Use Among Active American Members of the Cervical Spine Research Society.

    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

    authors: Bernstein DN,Melone G,Jubril A,Zhang J,Mesfin A

    更新日期:2021-01-04 00:00:00

  • Expansive Laminoplasty Versus Laminectomy Alone Versus Laminectomy and Fusion for Cervical Ossification of the Posterior Longitudinal Ligament: Is There a Difference in the Clinical Outcome and Sagittal Alignment?

    abstract:STUDY DESIGN:Intervention comparison study. OBJECTIVE:To assess postoperative cervical lordosis, clinical outcome, and progression of ossification of the posterior longitudinal ligament (OPLL) in patient of cervical spondylotic myelopathy (CSM) by the OPLL. SUMMARY OF BACKGROUND DATA:The posterior approach is usually...

    journal_title:Clinical spine surgery

    pub_type: 杂志文章

    doi:10.1097/BSD.0000000000000058

    authors: Lee CH,Jahng TA,Hyun SJ,Kim KJ,Kim HJ

    更新日期:2016-02-01 00:00:00

  • Why a P-Value is Not Enough.

    abstract:BACKGROUND:All doctors know that P-value<0.05 is "the Graal," but publications require further parameters [odds ratios, confidence interval (CI), etc.] to better analyze scientific data. AIM:The aim of this study was to present P-values, CI, and common effect-sizes (Cohen d, odds ratio, and various coefficients) in a ...

    journal_title:Clinical spine surgery

    pub_type: 杂志文章

    doi:10.1097/BSD.0000000000000695

    authors: Solla F,Tran A,Bertoncelli D,Musoff C,Bertoncelli CM

    更新日期:2018-11-01 00:00:00

  • Impact of Inpatient Venous Thromboembolism Continues After Discharge: Retrospective Propensity Scored Analysis in a Longitudinal Database.

    abstract:STUDY DESIGN:Propensity score matched retrospective study using a nationwide longitudinal database. OBJECTIVE:To quantify the longitudinal economic impact of venous thromboembolism (VTE) complications in spinal fusion patients. SUMMARY OF BACKGROUND DATA:VTE is a rare and serious complication that may occur after spi...

    journal_title:Clinical spine surgery

    pub_type: 杂志文章

    doi:10.1097/BSD.0000000000000450

    authors: Li AY,Azad TD,Veeravagu A,Bhatti I,Li A,Cole T,Desai A,Ratliff JK

    更新日期:2017-12-01 00:00:00

  • Proximal Junctional Kyphosis Following Posterior Hemivertebra Resection and Short Fusion in Children Younger Than 10 Years.

    abstract:STUDY DESIGN:A retrospective study. OBJECTIVE:To investigate whether proximal junctional kyphosis (PJK) or obvious proximal junctional angle (PJA) changes in the sagittal plane develops following short fusion in children younger than 10 years of age with congenital scoliosis, and to investigate the possible risk facto...

    journal_title:Clinical spine surgery

    pub_type: 杂志文章

    doi:10.1097/BSD.0000000000000245

    authors: Wang Y,Kawakami N,Tsuji T,Ohara T,Suzuki Y,Saito T,Nohara A,Tauchi R,Kawakami K

    更新日期:2017-05-01 00:00:00

  • Does Sagittal Spinopelvic Configuration Influence Vertebral Fracture Type or Localization in Trauma Patients?: A Retrospective Radiologic Analysis.

    abstract:STUDY DESIGN:Retrospective data analysis. OBJECTIVE:The aim of this study was to analyze correlations between spinopelvic configuration and fracture pattern or location in traumatic vertebral fractures. SUMMARY OF BACKGROUND DATA:The spinopelvic configuration represented by the pelvic incidence (PI) angle showed to h...

    journal_title:Clinical spine surgery

    pub_type: 杂志文章

    doi:10.1097/BSD.0000000000000035

    authors: Bouaicha S,Cunier M,Scheyerer MJ,Wanner GA,Simmen HP,Werner CM

    更新日期:2017-04-01 00:00:00

  • Correlation of Lower Instrumented Vertebra With Spinal Mobility and Health-related Quality of Life After Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis.

    abstract:STUDY DESIGN:This is a retrospective single-center and single-surgeon study. OBJECTIVE:We investigated the correlation between lower instrumented vertebra (LIV) and spinal mobility 2 years after posterior spinal fusion with pedicle screws for adolescent idiopathic scoliosis (AIS) for optimal LIV selection. SUMMARY OF...

    journal_title:Clinical spine surgery

    pub_type: 杂志文章

    doi:10.1097/BSD.0000000000000794

    authors: Uehara M,Takahashi J,Ikegami S,Kuraishi S,Futatsugi T,Oba H,Takizawa T,Munakata R,Koseki M,Kato H

    更新日期:2019-08-01 00:00:00

  • Degenerative Spondylolisthesis in the Fifth Lumbar Vertebra and Radiographic Parameters: A Correlation Analysis.

    abstract:STUDY DESIGN:A retrospective study. OBJECTIVE:This study aimed to analyze the relationships between degenerative spondylolisthesis in the fifth lumbar vertebra (L5-DS) and radiographic parameters and to further determine the radiographic predictors of the development of L5-DS. SUMMARY OF BACKGROUND DATA:Degenerative ...

    journal_title:Clinical spine surgery

    pub_type: 杂志文章

    doi:10.1097/BSD.0000000000000427

    authors: Chen Q,Cao L,Bian C,Wang HR,Lin H,Li XL,Jiang YQ,Dong J

    更新日期:2017-11-01 00:00:00

  • Clinical Outcome After Anterior Lumbar Interbody Fusion With a New Osteoinductive Bone Substitute Material: A Randomized Clinical Pilot Study.

    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-S...

    journal_title:Clinical spine surgery

    pub_type: 杂志文章,随机对照试验

    doi:10.1097/BSD.0000000000000802

    authors: Rickert M,Fleege C,Papachristos I,Makowski MR,Rauschmann M,Arabmotlagh M

    更新日期:2019-08-01 00:00:00

  • Current Concepts: Central Cord Syndrome.

    abstract::Central cord syndrome (CCS) represents a clinical phenomenon characterized by disproportionately greater motor impairment of the upper than of the lower extremities, bladder dysfunction. CSS is the most common form of incomplete traumatic spinal cord injury. The initial description of CSS was reported in 1887 secondar...

    journal_title:Clinical spine surgery

    pub_type: 杂志文章

    doi:10.1097/BSD.0000000000000731

    authors: Hashmi SZ,Marra A,Jenis LG,Patel AA

    更新日期:2018-12-01 00:00:00

  • Bariatric Surgery Before Elective Anterior Cervical Discectomy and Fusion (ACDF) in Obese Patients Is Associated With Reduced Risk of 90-Day Postoperative Complications and Readmissions.

    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

    authors: Malik AT,Noria S,Xu W,Retchin S,Yu ES,Khan SN

    更新日期:2020-12-07 00:00:00

  • Ethnic Variations in Radiographic Parameters and SRS-22 Scores in Adult Spinal Deformity: A Comparison Between North American and Japanese Patients Above 50 Years of Age With Minimum 2-Year Follow-up.

    abstract:STUDY DESIGN:Retrospective review of North American and Japanese adult spinal deformity (ASD) database. OBJECTIVE:To investigate the ethnical differences in radiographic parameters and Scoliosis Research Society (SRS)-22 between North American and Japanese ASD. SUMMARY OF BACKGROUND DATA:Previous comparison study bet...

    journal_title:Clinical spine surgery

    pub_type: 杂志文章

    doi:10.1097/BSD.0000000000000610

    authors: Hosogane N,Ames C,Matsumoto M,Yagi M,Matsuyama Y,Taneichi H,Yamato Y,Takeuchi D,Schwab F,Shaffrey C,Smith JS,Bess S,Lafage V,International Spine Study Group.

    更新日期:2018-06-01 00:00:00

  • Characterizing the Surgeon Learning Curve in Instrumented Minimally Invasive Spinal Surgery: Does the Evidence Account for Training and Experience? A Systematic Literature Review.

    abstract:STUDY DESIGN:This was a systematic literature review. OBJECTIVE:The purpose of this systematic literature review was to aggregate all evidence characterizing the learning curve of instrumented minimally invasive surgery (MIS) techniques in spinal surgery and summarize what, if any, consideration has been given to surg...

    journal_title:Clinical spine surgery

    pub_type: 杂志文章

    doi:10.1097/BSD.0000000000001052

    authors: Ferry C

    更新日期:2021-02-01 00:00:00

  • A Novel Groove-Entry Technique for Inserting Thoracic Percutaneous Pedicle Screws.

    abstract:STUDY DESIGN:Surgical technique. OBJECTIVE:To evaluate the efficacy of a novel groove-entry technique for thoracic percutaneous pedicle screw (PPS) insertion. SUMMARY OF BACKGROUND DATA:Minimally invasive spine stabilization (MISt) using posterior thoracolumbar instrumentation has many advantages over open procedures...

    journal_title:Clinical spine surgery

    pub_type: 杂志文章

    doi:10.1097/BSD.0000000000000461

    authors: Ishii K,Shiono Y,Funao H,Singh K,Matsumoto M

    更新日期:2017-03-01 00:00:00

  • Prognostic Role of Rib Hump in Overlying Thoracic Curve Correction Above Selective Fusion for Lenke 5 Idiopathic Adolescent Scoliosis.

    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

    authors: Solla F,Gallo M,Doria C,Caci H,Voury A,Rosello O,Clément JL,Rampal V

    更新日期:2018-03-01 00:00:00

  • Understanding Competition in Spine Care.

    abstract::The changing landscape from volume to value represents a natural transformation in the health care industry. Increasingly provider groups are finding themselves responding to unfamiliar market forces. Whether explicit or implicit, competition is playing a larger role for the sustainability of providers. For spine care...

    journal_title:Clinical spine surgery

    pub_type: 杂志文章

    doi:10.1097/BSD.0000000000000370

    authors: Sharan AD,Schroeder GD,West ME,Vaccaro AR

    更新日期:2016-04-01 00:00:00

  • Utility of the Surgical Apgar Score for Patients Who Undergo Surgery for Spinal Metastasis.

    abstract:STUDY DESIGN:Retrospective review of patients who underwent surgery for spinal metastasis between 2005 and 2011. OBJECTIVE:To assess the utility of the surgical Apgar score (SAS) in patients who underwent surgery for spinal metastasis. SUMMARY OF BACKGROUND DATA:Surgery for spinal metastasis can be associated with re...

    journal_title:Clinical spine surgery

    pub_type: 杂志文章

    doi:10.1097/BSD.0000000000000174

    authors: Lau D,Yee TJ,La Marca F,Patel R,Park P

    更新日期:2017-10-01 00:00:00

  • Adjacent Segment Disease in the Cervical and Lumbar Spine.

    abstract::Adjacent segment disease (ASD) is disappointing long-term outcome for both the patient and clinician. In contrast to adjacent segment degeneration, which is a common radiographic finding, ASD is less common. The incidence of ASD in both the cervical and lumbar spine is between 2% and 4% per year, and ASD is a signific...

    journal_title:Clinical spine surgery

    pub_type: 杂志文章,评审

    doi:10.1097/BSD.0000000000000442

    authors: Tobert DG,Antoci V,Patel SP,Saadat E,Bono CM

    更新日期:2017-04-01 00:00:00

  • Factors Affecting the Nonlinear Force Versus Distraction Height Curves in an In Vitro C5-C6 Anterior Cervical Distraction Model.

    abstract:STUDY DESIGN:In vitro biomechanical study of cervical intervertebral distraction. OBJECTIVE:To investigate the forces required for distraction to different heights in an in vitro C5-C6 anterior cervical distraction model, focusing on the influence of the intervertebral disk, posterior longitudinal ligament (PLL), and ...

    journal_title:Clinical spine surgery

    pub_type: 杂志文章

    doi:10.1097/BSD.0000000000000160

    authors: Wen J,Xu J,Li L,Yang M,Pan J,Chen D,Jia L,Tan J

    更新日期:2017-06-01 00:00:00

  • Role of Posterior Stabilization and Transpedicular Decompression in the Treatment of Thoracic and Thoracolumbar TB: A Retrospective Evaluation.

    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

    authors: D'souza AR,Mohapatra B,Bansal ML,Das K

    更新日期:2017-12-01 00:00:00

  • Organizational Structural Design in Spine Care.

    abstract::For a company to provide high value to its customers, its organization design is critical. As health care transitions to a value-based model, it is critical that spinal care organizations are structured in such a way that they can maximize value to both the patient and the payers. This article will discuss the 3 most ...

    journal_title:Clinical spine surgery

    pub_type: 杂志文章

    doi:10.1097/BSD.0000000000000529

    authors: Sharan AD,Schroeder GD,West ME,Vaccaro AR

    更新日期:2017-04-01 00:00:00

  • Predictors and Long-term Outcome of Sexual Function After Surgical Treatment for Single-level Lumbar Disk Herniation Among Patients in a German Spine Center.

    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

    authors: Elsharkawy AE,Lange B,Caldas F,Alabbasi AH,Klassen PD

    更新日期:2018-10-01 00:00:00

  • Comparing Patient-reported Outcomes to Patient Satisfaction After a Microdiscectomy for Patient's With a Lumbar Disk Herniation.

    abstract:STUDY DESIGN:A retrospective cohort study. OBJECTIVE:The objective of this study was to determine if patient satisfaction is predicted by improvement in health-related quality of life (HRQOL) metrics. SUMMARY OF BACKGROUND DATA:Patient satisfaction is becoming an increasingly common proxy for treatment quality; howev...

    journal_title:Clinical spine surgery

    pub_type: 杂志文章

    doi:10.1097/BSD.0000000000000887

    authors: Schroeder GD,Radcliff KE,Vaccaro AR,Murphy H,Sutton RM,Lurie JD,Zhao W,Hilibrand AS

    更新日期:2020-03-01 00:00:00

  • A New Method of Measuring the Occipitocervical Angle That Could be Applied as an Intraoperative Indicator During Occipitocervical Fusion.

    abstract:STUDY DESIGN:A method for measuring occipitocervical angle. OBJECTIVE:To develop a new method of measurement for assessing the occipitocervical angle using intraoperative fluoroscopic imaging, and to examine its reliability. SUMMARY OF BACKGROUND DATA:To avoid postoperative complications following occipitocervical fu...

    journal_title:Clinical spine surgery

    pub_type: 杂志文章

    doi:10.1097/BSD.0000000000000478

    authors: Nagashima S,Nagae M,Arai Y,Tonomura H,Takatori R,Sukenari T,Fujiwara H,Sawada K,Mikami Y,Kubo T

    更新日期:2017-08-01 00:00:00

  • Unilateral Biportal Endoscopy Versus Tubular Microendoscopy in Management of Single Level Degenerative Lumbar Canal Stenosis: A Prospective Study.

    abstract:STUDY DESIGN:Prospective clinical study. SUMMARY OF BACKGROUND DATA:To the authors knowledge, there are no previous prospective studies to test the feasibility of the unilateral biportal endoscopic (UBE) technique in management of lumbar canal stenosis. PURPOSE:The study was conducted to compare clinical results of t...

    journal_title:Clinical spine surgery

    pub_type: 杂志文章

    doi:10.1097/BSD.0000000000001122

    authors: Aygun H,Abdulshafi K

    更新日期:2021-01-15 00:00:00

  • Cost-utility Analysis for Recurrent Lumbar Disc Herniation: Conservative Treatment Versus Discectomy Versus Discectomy With Fusion.

    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

    authors: Selva-Sevilla C,Ferrara P,Gerónimo-Pardo M

    更新日期:2019-06-01 00:00:00

  • Conservative and Operative Treatment in Extension Teardrop Fractures of the Axis.

    abstract:STUDY DESIGN:A retrospective case series describing teardrop fracture of the axis. OBJECT:The purpose of the study was to clarify the clinical features, the mechanism of injury, and the potential instability of extension teardrop fractures of the axis, so as to emphasize the importance of recognizing this injury as a ...

    journal_title:Clinical spine surgery

    pub_type: 杂志文章

    doi:10.1097/BSD.0b013e31828984f9

    authors: Hu Y,Kepler CK,Albert TJ,Hann S,Ma WH,Yuan ZS,Dong WX,Xu RM

    更新日期:2016-02-01 00:00:00