Comparing Nonrandomized Observational Studies With Randomized Controlled Trials in Cervical Disc Arthroplasty: A Meta-analysis.


STUDY DESIGN:Systematic review and meta-analysis. OBJECTIVE:To compare the treatment effects of observational studies versus randomized controlled trials (RCTs) in cervical disc arthroplasty. SUMMARY OF BACKGROUND DATA:RCTs can be logistically challenging and sometimes insufficiently generalizable; well-designed observational studies have been suggested as an alternative. We hypothesized that treatment effects of observational studies in cervical disc arthroplasty are similar to those of RCTs. METHODS:We searched electronic database from 2000 to 2014. The Neck Disability Index (NDI) was the primary outcome from which the standardized pre-and-post mean difference (Hedges's g) was determined. Meta-analysis was performed to compare Hedges's g from observational studies to that of RCTs. Potential moderator variables including study quality, age, gender, industry sponsorship, location by continent, and disc types were also collected and analyzed. Observational studies were further stratified into prospective and retrospective, and they were compared to each other as well as to RCTs. RESULTS:We identified nine RCTs, 28 observational studies, and one hybrid study for meta-analysis. NDI Hedges's g was 2.15 for RCTs and 2.03 for observational studies, which was not significant (P = 0.416). No significant difference was found in secondary outcomes. However, after further stratification, prospective observational studies had less treatment effect in Visual Analog Scale neck compared with that of RCTs (1.60 vs. 2.11, P = 0.006). RCTs recruited younger patients (44.1 vs. 45.6, P = 0.008) with worse NDI at baseline (54.30 vs. 46.92, P < 0.001). Patients treated with ProDisc-C showed less standardized improvement on the NDI compared with the patients treated with Prestige (1.41 vs. 2.48, P = 0.026). CONCLUSION:Prospective observational studies that utilize the same features of RCTs such as inclusion and exclusion criteria validated clinical outcomes, and statistical methods can provide valuable information about the treatment effects on a generalizable population. LEVEL OF EVIDENCE:4.


Spine (Phila Pa 1976)




Jee YM,Bak JS,Weinlander E,Anderson PA




Has Abstract


2016-03-01 00:00:00














  • A study of the diagnostic accuracy and reliability of the Scoliometer and Adam's forward bend test.

    abstract:STUDY DESIGN:Study of the diagnostic accuracy and interexaminer reliability of scoliosis diagnostic tests. OBJECTIVES:To estimate the sensitivity, specificity, and predictive value of the Scoliometer (National Scoliosis Foundation, Watertown, MA) and Adam's forward bend test in diagnosing scoliosis, and to determine t...


    pub_type: 杂志文章


    authors: Côté P,Kreitz BG,Cassidy JD,Dzus AK,Martel J

    更新日期:1998-04-01 00:00:00

  • Creep and fatigue development in the low back in static flexion.

    abstract:STUDY DESIGN:In vivo measurements of low back flexion posture and muscle activity before, during, and after static flexion. OBJECTIVE:To identify the occurrence of creep and muscle fatigue development in the low back during static upper body deep flexion that resembled an above ground work posture. SUMMARY OF BACKGRO...


    pub_type: 杂志文章


    authors: Shin G,D'Souza C,Liu YH

    更新日期:2009-08-01 00:00:00

  • Depression is associated with a poorer outcome of lumbar spinal stenosis surgery: a two-year prospective follow-up study.

    abstract:STUDY DESIGN:Prospective clinical study. OBJECTIVE:To investigate the effect of depressive symptoms on the surgery outcome on 2-year follow-up among lumbar spinal stenosis (LSS) patients. SUMMARY OF BACKGROUND DATA:Previous research has suggested an association between preoperative depressive symptoms and a poorer su...


    pub_type: 杂志文章


    authors: Sinikallio S,Aalto T,Airaksinen O,Lehto SM,Kröger H,Viinamäki H

    更新日期:2011-04-15 00:00:00

  • The effect of anterior-posterior shear on the wear of CHARITÉ total disc replacement.

    abstract:STUDY DESIGN:An in vitro study of the wear rates of the CHARITÉ lumbar total disc replacement (TDR). OBJECTIVE:To investigate the effect of anterior-posterior shear on the in vitro wear rates of the CHARITÉ lumbar TDR. SUMMARY OF BACKGROUND DATA:Current standards prescribe only 4-degrees of freedom (DOF) inputs for e...


    pub_type: 杂志文章


    authors: Vicars R,Prokopovich P,Brown TD,Tipper JL,Ingham E,Fisher J,Hall RM

    更新日期:2012-04-20 00:00:00

  • Comparison of the flat torso versus the elevated torso shoulder pad removal techniques in a cadaveric cervical spine instability model.

    abstract:STUDY DESIGN:Controlled laboratory study in a cadaveric model. OBJECTIVE:To determine if removing shoulder pads using the elevated torso technique generated less spinal segment motion than using the flat torso method. SUMMARY OF BACKGROUND DATA:Guidelines for care of the injured football player with a suspected spina...


    pub_type: 杂志文章


    authors: Horodyski M,DiPaola CP,DiPaola MJ,Conrad BP,Del Rossi G,Rechtine GR 2nd

    更新日期:2009-04-01 00:00:00

  • Preventive interventions for back and neck pain problems: what is the evidence?

    abstract:STUDY DESIGN:A review of controlled trials. OBJECTIVES:To determine which interventions are used to prevent back and neck pain problems as well as what the evidence is for their utility. SUMMARY OF BACKGROUND DATA:Given the difficulty in successfully treating long-term back and neck pain problems, there has been a ca...


    pub_type: 临床试验,杂志文章,评审


    authors: Linton SJ,van Tulder MW

    更新日期:2001-04-01 00:00:00

  • Electrically induced muscle contractions influence bone density decline after spinal cord injury.

    abstract:STUDY DESIGN:Longitudinal repeated-measures; within-subject control. OBJECTIVE:We examined the extent to which an isometric plantar flexion training protocol attenuates bone loss longitudinally after SCI. SUMMARY OF BACKGROUND DATA:After spinal cord injury (SCI), bone mineral density (BMD) of paralyzed extremities ra...


    pub_type: 杂志文章


    authors: Shields RK,Dudley-Javoroski S,Law LA

    更新日期:2006-03-01 00:00:00

  • Surgical site infections in spine surgery: identification of microbiologic and surgical characteristics in 239 cases.

    abstract:STUDY DESIGN:Retrospective analysis. OBJECTIVE:The objective of this study was to describe the microbiology of surgical site infection (SSI) in spine surgery and relationship with surgical management characteristics. SUMMARY OF BACKGROUND DATA:SSI is an important complication of spine surgery that results in signific...


    pub_type: 杂志文章


    authors: Abdul-Jabbar A,Berven SH,Hu SS,Chou D,Mummaneni PV,Takemoto S,Ames C,Deviren V,Tay B,Weinstein P,Burch S,Liu C

    更新日期:2013-10-15 00:00:00

  • Postlaminectomy kyphosis in the skeletally immature achondroplast.

    abstract:STUDY DESIGN:Retrospective review. OBJECTIVES:To determine the risk of postlaminectomy thoracolumbar kyphosis in skeletally immature achondroplasts and evaluate the need for concurrent fusion at multilevel decompression. SUMMARY OF BACKGROUND DATA:Spinal stenosis is a relatively common complication of achondroplasia....


    pub_type: 杂志文章


    authors: Ain MC,Shirley ED,Pirouzmanesh A,Hariri A,Carson BS

    更新日期:2006-01-15 00:00:00

  • Postural alignment in barefoot and high-heeled stance.

    abstract::The posture of nineteen subjects under two conditions of footwear was analyzed for differences in the location of the line of gravity of the body with respect to anatomical landmarks. Intrasubject comparison of barefoot and high-heeled stance showed that the wearing of high heels caused lumbar flattening, a backward t...


    pub_type: 杂志文章


    authors: Opila KA,Wagner SS,Schiowitz S,Chen J

    更新日期:1988-05-01 00:00:00

  • Scheuermann kyphosis: the importance of tight hamstrings in the surgical correction.

    abstract:STUDY DESIGN:A historic cohort study of the sagittal alignment in 33 consecutive patients with surgically corrected thoracic Scheuermann kyphosis. OBJECTIVES:To determine if postsurgical imbalance, sagittal malalignment, and decreased lumbar-pelvic range of motion in patients with thoracic Scheuermann kyphosis is rela...


    pub_type: 临床试验,杂志文章


    authors: Hosman AJ,de Kleuver M,Anderson PG,van Limbeek J,Langeloo DD,Veth RP,Slot GH

    更新日期:2003-10-01 00:00:00

  • Anterior neck recording of intraoperative somatosensory-evoked potentials in children.

    abstract:STUDY DESIGN:The authors have developed technique of using anterior neck derivations to record posterior tibial nerve N28 during operative somatosensory-evoked potential monitoring. OBJECTIVE:This prospective study of 10 patients compared the ease of application of electrodes and stability of waveforms with "tradition...


    pub_type: 杂志文章


    authors: Helmers SL,Carmant L,Flanigin D

    更新日期:1995-04-01 00:00:00

  • Recurrent Proximal Junctional Kyphosis: Incidence, Risk Factors, Revision Rates, and Outcomes at 2-Year Minimum Follow-up.

    abstract:STUDY DESIGN:Retrospective comparative cohort study. OBJECTIVE:Assess the incidence, risk factors, and outcomes of recurrent proximal junctional kyphosis (r-PJK) in PJK revision patients. SUMMARY OF BACKGROUND DATA:Several studies have identified the incidence and risk factors for PJK after primary surgery. However, ...


    pub_type: 杂志文章


    authors: Kim HJ,Wang SJ,Lafage R,Iyer S,Shaffrey C,Mundis G,Hostin R,Burton D,Ames C,Klineberg E,Gupta M,Smith J,Schwab F,Lafage V,International Spine Study Group.

    更新日期:2020-01-01 00:00:00

  • Mechanical destabilization induced by controlled annular incision of the intervertebral disc dysregulates metalloproteinase expression and induces disc degeneration.

    abstract:STUDY DESIGN:An investigation of mechanical destabilization of the lumbar ovine intervertebral disc (IVD) inducing IVD degeneration (IVDD) as determined by multiparameter outcome measures (magnetic resonance imaging [MRI], IVD composition, biomechanical testing, gene profiling, immunohistochemistry, and immunoblotting)...


    pub_type: 杂志文章


    authors: Melrose J,Shu C,Young C,Ho R,Smith MM,Young AA,Smith SS,Gooden B,Dart A,Podadera J,Appleyard RC,Little CB

    更新日期:2012-01-01 00:00:00

  • Pelvic bone asymmetry in 323 study participants receiving abdominal CT scans.

    abstract:STUDY DESIGN:Retrospective review of all CT scans of pelvis and abdomen performed at our institution in October and November 2000. OBJECTIVE:To determine the prevalence and extent of radiographic pelvic asymmetry in a population of patients not preselected for having low back pain. SUMMARY OF BACKGROUND DATA:Pelvic a...


    pub_type: 杂志文章


    authors: Badii M,Shin S,Torreggiani WC,Jankovic B,Gustafson P,Munk PL,Esdaile JM

    更新日期:2003-06-15 00:00:00

  • Spinal cord dimensions in children with Klippel-Feil syndrome: a controlled, blinded radiographic analysis with implications for neurologic outcomes.

    abstract:STUDY DESIGN:Retrospective case series. OBJECTIVE:To evaluate the axial cross-sectional dimensions of the spinal cord and cerebrospinal fluid (CSF) column in children with Klippel-Feil Syndrome (KFS) versus an age-matched cohort of control subjects. SUMMARY OF BACKGROUND DATA:Neurologic sequelae and chronic pain are ...


    pub_type: 杂志文章


    authors: Auerbach JD,Hosalkar HS,Kusuma SK,Wills BP,Dormans JP,Drummond DS

    更新日期:2008-05-20 00:00:00

  • Antenatal factors in the development of the lumbar vertebral canal: a magnetic resonance imaging study.

    abstract:STUDY DESIGN:The lumbar vertebral canal was measured in two cohorts of 10-year-old children (n = 161) using magnetic resonance imaging (MRI) and compared with obstetric records. OBJECTIVE:To investigate whether there are identifiable obstetric factors that determine the size of the lumbar vertebral canal. SUMMARY OF ...


    pub_type: 杂志文章


    authors: Jeffrey JE,Campbell DM,Golden MH,Smith FW,Porter RW

    更新日期:2003-07-01 00:00:00

  • Pulmonary embolism in spine surgery: a comparison of combined anterior/posterior approach versus posterior approach surgery.

    abstract:STUDY DESIGN:retrospective review. OBJECTIVE:to determine if Anterior/Posterior Combined approach spine surgery is associated with an increased risk of pulmonary embolism (PE) compared to Posterior Only approach surgery. SUMMARY OF BACKGROUND DATA:combined anterior/posterior approach spine surgery is associated with ...


    pub_type: 杂志文章


    authors: Kim HJ,Kepler C,Cunningham M,Rawlins B,Boachie-Adjei O

    更新日期:2011-01-15 00:00:00

  • Comorbid subjective health complaints in low back pain.

    abstract:STUDY DESIGN:Cross-sectional study. OBJECTIVES:To compare subjective health complaints in subacute patients with low back pain with reference values from a Norwegian normal population. SUMMARY OF BACKGROUND DATA:Comorbidity is common with nonspecific low back pain. We wanted to investigate if these complaints were sp...


    pub_type: 杂志文章


    authors: Hagen EM,Svensen E,Eriksen HR,Ihlebaek CM,Ursin H

    更新日期:2006-06-01 00:00:00

  • Viscoelastic properties of intervertebral disc cells. Identification of two biomechanically distinct cell populations.

    abstract:STUDY DESIGN:A combined experimental and theoretical biomechanical study to quantify the mechanical properties of living cells of the porcine intervertebral disc. OBJECTIVES:To quantify zonal variations in the mechanical properties and morphology of cells isolated from the intervertebral disc. SUMMARY OF BACKGROUND D...


    pub_type: 杂志文章


    authors: Guilak F,Ting-Beall HP,Baer AE,Trickey WR,Erickson GR,Setton LA

    更新日期:1999-12-01 00:00:00

  • Risk factors and precipitating neck movements causing vertebrobasilar artery dissection after cervical trauma and spinal manipulation.

    abstract:STUDY DESIGN:Potential precipitating events and risk factors for vertebrobasilar artery dissection were reviewed in an analysis of the English language literature published before 1993. OBJECTIVES:To assess the literature pertaining to precipitating neck movements and risk factors for vertebrobasilar artery dissection...


    pub_type: 杂志文章,评审


    authors: Haldeman S,Kohlbeck FJ,McGregor M

    更新日期:1999-04-15 00:00:00

  • Using segmental renal artery as recipient artery for spinal reconstructive surgery.

    abstract:STUDY DESIGN:Report of the use of one segmental artery from the left renal artery as inflow source for reconstructing a spine with recalcitrant osteomyelitis. OBJECTIVE:To describe one difficult case of spinal osteomyelitis and our reconstruction procedure. SUMMARY OF BACKGROUND DATA:The use of a vascularized fibular...


    pub_type: 杂志文章


    authors: Yen YH,Hsieh TS,Hou SM,Wu SJ,Chen SC,Pu CM

    更新日期:2010-12-01 00:00:00

  • Postoperative Resolution of MR T2 Increased Signal Intensity in Cervical Spondylotic Myelopathy: The Impact of Signal Change Resolution on the Outcomes.

    abstract:STUDY DESIGN:A prospective comparative imaging study. OBJECTIVE:This study investigated whether postoperative resolution of spinal cord increased signal intensity (ISI) reflected symptom improvement and surgical outcomes in cervical spondylotic myelopathy (CSM) patients. SUMMARY OF BACKGROUND DATA:Although some CSM p...


    pub_type: 杂志文章


    authors: Machino M,Ando K,Kobayashi K,Ota K,Morozumi M,Tanaka S,Ito K,Kato F,Ishiguro N,Imagama S

    更新日期:2019-11-01 00:00:00

  • Tumor necrosis factor-α-dependent infiltration of macrophages into the dorsal root ganglion in a rat disc herniation model.

    abstract:STUDY DESIGN:A prospective molecular mechanism of macrophages infiltration in experimental disc herniation. OBJECTIVE:To investigate the mechanisms of macrophages infiltration into the dorsal root ganglion (DRG) in a rat model of disc herniation. SUMMARY OF BACKGROUND DATA:Macrophages infiltrate the DRG after applica...


    pub_type: 杂志文章


    authors: You C,Zhu K,Liu X,Xi C,Zhang Z,Xu G,Yan J

    更新日期:2013-11-01 00:00:00

  • Preoperative and Postoperative Sitting Radiographs for Adult Spinal Deformity Surgery: Upper Instrumented Vertebra Selection Using Sitting C2 Plumb Line Distance to Prevent Proximal Junctional Kyphosis.

    abstract:STUDY DESIGN:Case-control study from a continuous series. OBJECTIVES:To study the impact of perioperative sitting radiographs in adult spinal deformity (ASD) patients and determine whether proximal junctional kyphosis (PJK) can be prevented using preoperative sitting radiograph. SUMMARY OF BACKGROUND DATA:Radiographi...


    pub_type: 杂志文章


    authors: Yoshida G,Ushirozako H,Hasegawa T,Yamato Y,Kobayashi S,Yasuda T,Banno T,Arima H,Oe S,Mihara Y,Ide K,Watanabe Y,Yamada T,Togawa D,Matsuyama Y

    更新日期:2020-08-01 00:00:00

  • Biomechanical study of C1-C2 posterior arthrodesis techniques.

    abstract::Fifteen cervical spines from cadavers were used to compare the rotational and translational stability of the Brooks fusion, a fusion construct using Halifax interlaminar clamps, and the Gallie fusion. The Brooks and Halifax clamp constructs exhibited significantly greater rotational and translational stiffness than th...


    pub_type: 杂志文章


    authors: Hajek PD,Lipka J,Hartline P,Saha S,Albright JA

    更新日期:1993-02-01 00:00:00

  • Trends in Comorbidities and Complications Among Patients Undergoing Inpatient Spine Surgery.

    abstract:STUDY DESIGN:Retrospective database study. OBJECTIVE:We sought to identify trends in demographics, comorbidities, and postoperative complications among patients undergoing ACDF and PLF. SUMMARY OF BACKGROUND DATA:As demand for anterior cervical discectomy and fusion (ACDF) and posterior lumbar fusion (PLF) surgery co...


    pub_type: 杂志文章


    authors: Wilson LA,Fiasconaro M,Liu J,Bekeris J,Poeran J,Kim DH,Girardi F,Sama A,Memtsoudis SG

    更新日期:2020-09-15 00:00:00

  • S1 tuberculosis treated with segmental lumbopelvic fixation: a case report.

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    pub_type: 杂志文章


    authors: Shah SP,Kulkarni AG

    更新日期:2012-06-15 00:00:00

  • Concurrent measurement of isokinetic muscle strength of the trunk, knees, and ankles in patients with lumbar disc herniation with sciatica.

    abstract:STUDY DESIGN:A cross-sectional study comparing normal subjects and patients with lumbar disc herniation (LDH) with sciatica. OBJECTIVE:To simultaneously measure the isokinetic muscle strength of the trunk, knees, and ankles in both groups. SUMMARY OF BACKGROUND DATA:Coordination between the trunk and lower extremity ...


    pub_type: 杂志文章


    authors: Chen LC,Kuo CW,Hsu HH,Chang ST,Ni SM,Ho CW

    更新日期:2010-12-15 00:00:00

  • Direct Repair of Lumbar Pars Interarticularis Defects by Utilizing Intraoperative O-Arm-Based Navigation and Microendoscopic Techniques.

    abstract:STUDY DESIGN:A retrospective analysis of the clinical outcomes of eight patients with the lumbar pars interarticulars defects treated by direct repair with the aid of intraoperative O-arm based navigation and microendoscopic techniques. OBJECTIVE:The aim of this study was to investigate the efficacy and safety of dire...


    pub_type: 杂志文章


    authors: Jia M,Wang J,Zhang Z,Zheng W,Zhou Y

    更新日期:2016-10-01 00:00:00