***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results BACKGROUND CONTEXT Cervical total disc replacement ( TDR ) is intended to address radicular pain and preserve functional motion between two vertebral bodies in patients with symptomatic cervical disc disease ( SCDD ) . PURPOSE The purpose of this trial is to compare the safety and efficacy of cervical TDR , ProDisc-C ( Synthes Spine Company , L.P. , West Chester , PA ) , to anterior cervical discectomy and fusion ( ACDF ) surgery for the treatment of one-level SCDD between C3 and C7 . STUDY DESIGN / SETTING The study was conducted at 13 sites . A noninferiority design with a 1:1 r and omization was used . PATIENT SAMPLE Two hundred nine patients were r and omized and treated ( 106 ACDF ; 103 ProDisc-C ) . OUTCOME MEASURES Visual analog scale ( VAS ) pain and intensity ( neck and arm ) , VAS satisfaction , neck disability index ( NDI ) , neurological exam , device success , adverse event occurrence , and short form-36 ( SF-36 ) st and ardized question naires . METHODS A prospect i ve , r and omized , controlled clinical trial was performed . Patients were enrolled and treated in accordance with the US Food and Drug Administration ( FDA ) -approved protocol . Patients were assessed pre- and postoperatively at six weeks , 3 , 6 , 12 , 18 , and 24 months . RESULTS Demographics were similar between the two patient groups ( ProDisc-C : 42.1+/-8.4 years , 44.7 % males ; Fusion : 43.5 + /- 7.1 years , 46.2 % males ) . The most commonly treated level was C5-C6 ( ProDisc-C : 56.3 % ; Fusion=57.5 % ) . NDI and SF-36 scores were significantly less compared with presurgery scores at all follow-up visits for both the treatment groups ( p<.0001 ) . VAS neck pain intensity and frequency as well as VAS arm pain intensity and frequency were statistically lower at all follow-up timepoints compared with preoperative levels ( p<.0001 ) but were not different between treatments . Neurologic success ( improvement or maintenance ) was achieved at 24 months in 90.9 % of ProDisc-C and 88.0 % of Fusion patients ( p=.638 ) . Results show that at 24 months postoperatively , 84.4 % of ProDisc-C patients achieved a more than or equal to 4 degrees of motion or maintained motion relative to preoperative baseline at the operated level . There was a statistically significant difference in the number of secondary surgeries with 8.5 % of Fusion patients needing a re-operation , revision , or supplemental fixation within the 24 month postoperative period compared with 1.8 % of ProDisc-C patients ( p=.033 ) . At 24 months , there was a statistically significant difference in medication usage with 89.9 % of ProDisc-C patients not on strong narcotics or muscle relaxants , compared with 81.5 % of Fusion patients . CONCLUSIONS The results of this clinical trial demonstrate that ProDisc-C is a safe and effective surgical treatment for patients with disabling cervical radiculopathy because of single-level disease . By all primary and secondary measures evaluated , clinical outcomes after ProDisc-C implantation were either equivalent or superior to those same clinical outcomes after Fusion OBJECT The authors report the results of a prospect i ve r and omized multicenter study in which the results of cervical disc arthroplasty were compared with anterior cervical discectomy and fusion ( ACDF ) in patients treated for symptomatic single-level cervical degenerative disc disease ( DDD ) . METHODS Five hundred forty-one patients with single-level cervical DDD and radiculopathy were enrolled at 32 sites and r and omly assigned to one of two treatment groups : 276 patients in the investigational group underwent anterior cervical discectomy and decompression and arthroplasty with the PRESTIGE ST Cervical Disc System ( Medtronic Sofamor Danek ) ;  265 patients in the control group underwent decompressive ACDF . Eighty percent of the arthroplasty-treated patients ( 223 of 276 ) and 75 % of the control patients ( 198 of 265 ) completed clinical and radiographic follow-up examinations at routine intervals for 2 years after surgery . Analysis of all currently available postoperative 12- and 24-month data indicated a two-point greater improvement in the neck disability index score in the investigational group than the control group . The arthroplasty group also had a statistically significant higher rate of neurological success ( p = 0.005 ) as well as a lower rate of secondary revision surgeries ( p = 0.0277 ) and supplemental fixation ( p = 0.0031 ) . The mean improvement in the 36-Item Short Form Health Survey Physical Component Summary scores was greater in the investigational group at 12 and 24 months , as was relief of neck pain . The patients in the investigational group returned to work 16 days sooner than those in the control group , and the rate of adjacent-segment reoperation was significantly lower in the investigational group as well ( p = 0.0492 , log-rank test ) . The cervical disc implant maintained segmental sagittal angular motion averaging more than 7 degrees . In the investigational group , there were no cases of implant failure or migration . CONCLUSIONS The PRESTIGE ST Cervical Disc System maintained physiological segmental motion at 24 months after implantation and was associated with improved neurological success , improved clinical outcomes , and a reduced rate of secondary surgeries compared with ACDF Study Design . Radiographic results of a multicenter , prospect i ve r and omized study comparing  1-level cervical total disc replacement ( TDR-C ) with anterior cervical discectomy and fusion ( ACDF ) .  Objective . To evaluate the effect on device-level lordosis , cranial and caudal adjacent level lordosis , and overall cervical sagittal alignment ( C2–C6 ) after TDR-C or ACDF . Summary of Background Data . Cervical total disc replacement ( TDR-C ) has emerged as a promising alternative to ACDF in a select group of patients . The maintenance and /or improvement of sagittal balance is essential in preserving functionality after reconstructive spinal procedures . Recent studies have documented changes in spinal alignment after TDR-C , however , no studies have compared these changes to those noted in matched group of patients that have undergone ACDF . Methods . Radiographic data were obtained from the r and omized group of a multicenter , r and omized , prospect i ve , controlled study comparing TDR-C ( ProDisc-C , Synthes Spine , West Chester , PA ) with ACDF in the treatment of 1-level cervical disc disease . Complete radiographic data were available for 89 TDR-C patients ( average age : 42.2 years ) and 91 ACDF patients ( average age : 41.7 years ) .  Cervical lordosis at the device level , cranial and caudal adjacent levels , and total cervical lordosis ( C2–C6 ) were independently measured before surgery and 2 years after surgery using custom image stabilization software ( Quantitative Motion Analysis , Medical Metrics , Inc , Houston , TX ) . Results . C5–C6 was the most common operative level ( TDR-C : 54 % ; ACDF : 55 % ) . At 2 years after surgery , the TDR-C group experienced statistically significant changes in lordosis of 3.0 ° ( P < 0.001 ) , 0.90 ° ( P = 0.006 ) , and −1.9 ° ( P < 0.001 ) at the operative , cranial , and caudal adj-acent levels , respectively . ACDF experienced changes in lordosis of 4.2 ° ( P < 0.001 ) , 1.0 ° ( P = 0.001 ) , and −1.5 ° ( P = 0.001 ) , respectively . The between-group differences were significant at the operative level ( P = 0.03 ) and the caudal adjacent level ( P = 0.05 ) . Total cervical lordosis increased in both TDR-C and ACDF by 3.1 ° and 3.8 ° , respectively ( P = 0.49 ) . Conclusion . In both TDR-C and ACDF  , lordosis increased at the device-level , cranial adjacent level , and in total cervical lordosis , while lordosis decreased at the caudal adjacent level . Although ACDF facilitated a greater increase in device level lordosis ( + 1.25 ° ) and less loss of lordosis at the caudal adjacent level compared with TDR-C ( −0.39 ° ) , the clinical relevance of the small differences remain unknown Study Design . R and omized controlled study . Objective . To compare the rates of adverse events associated with disc arthroplasty versus those of anterior cervical discectomy and arthrodesis with allograft and plate . Summary of Background Data . Cervical disc arthroplasty as a substitute for fusion has been developed to maintain motion and , theoretically , prevent adjacent segment degeneration . Currently , cervical arthroplasty devices are undergoing clinical testing for safety and efficacy . The evaluation of safety is performed by critical analysis of all adverse occurrences following surgery to determine if the new device has a beneficial risk profile for the patient . Methods . Adverse events associated with Bryan Disc arthroplasty and arthrodesis were compared in a prospect i ve r and omized study . Four hundred sixty-three ( 463 ) patients having cervical radiculopathy and or myelopathy at a single level were treated at 31 sites . A total of 242 patients received the disc and 221 patients had anterior cervical discectomy and fusion .  All patients were evaluated before surgery and at 1.5 , 3 , 6 , 12 , and 24 months after surgery . Adverse events were recorded concurrently and categorized by severity and as medically or surgically related . Results . No differences in overall medical events occurred between groups . Surgically related events occurred more frequently in the investigational group secondary to more complaints of postoperative dysphagia and late medical events occurred more frequently in the investigational patients . However , the more severe World Health Organization Grade 3 and 4 events occurred more frequently in the arthrodesis patients related to treatment of pseudarthrosis and persistent symptoms . Significantly , more cervical spine reoperations occurred in the fusion group . Only one spinal cord injury occurred and it was in the arthrodesis group and no patients had deep infection or death related to either procedure . Conclusion . Bryan cervical disc replacement and anterior cervical fusion are both safe procedures with a low incidence of significant adverse events related to the procedure . Statistically , more serious adverse events and reoperations occurred in the fusion group while a greater number of less serious surgically related events were seen in the investigational group Study Design / Setting Prospect i ve , r and omized , 3-center , clinical trial . Objective To prospect ively compare the outcomes of cervical  arthroplasty with the BRYAN Cervical Disc Prosthesis ( Medtronic Sofamor Danek , Inc , Memphis , TN ) to anterior cervical discectomy and fusion ( ACDF ) . Summary of Background Data Surgical treatment of cervical disc pathology commonly involves techniques that employ discectomy and fusion ( ACDF ) . This “ gold-st and ard ” technique has demonstrated good clinical and radiographic outcomes . Common adverse effects of this procedure are associated with the adjacent level degeneration and bone-graft harvest . Several investigators have independently reported successful short-term outcomes with the BRYAN Cervical Disc Prosthesis . In addition , a significant body of knowledge has been collected regarding the wear patterns and adjacent level effects of this device in human and animal models . Methods As part of an FDA IDE trial , 3 centers collected prospect i ve outcomes data on 115 patients r and omized in a 1:1 ratio to ACDF ( Control group ) or arthroplasty with the BRYAN Cervical Disc Prosthesis ( Investigational group ) . Results Demographic and surgical data were generally similar in the 2 population s. Outcomes data collected at routine postoperative intervals for 24 months demonstrated that the Investigational group had statistically significant ( P<0.05 ) improvements as assessed by the Neck Disability Index , the Neck Pain Score , and SF-36 Physical component scores . The improvement in the Mental Component Subscore values for the BRYAN and control groups was equivalent at 24 months ( P=0.0 
    Output:
    
Adjacent-level degeneration has not been adequately studied in a review of the available r and omized controlled trials on this topic , and there is no clinical evidence of reduction in adjacent-level degeneration with the use of cervical arthroplasty