***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: OBJECTIVES To evaluate the outcome and satisfaction of closed treatment versus open reduction and internal fixation in comminuted clavicular fractures . METHODS Sixty patients with displaced clavicular fractures were r and omized into operative ( 29 patients ) and nonoperative ( 31 patients ) groups . Three patients in the operative group did not accept the surgery , and seven patients in the nonoperative group did not complete the one-year follow-up . Outcomes were assessed using the Disability of the Arm , Shoulder and H and ( DASH ) score , Constant shoulder score , specific questions regarding patients ' final satisfaction , physical examination , measurement of the shortening of the clavicular length , and plain radiographs . RESULTS There was one nonunion in the operative group and one in the nonoperative group . The nonunion in operative group was the result of the only infection in this group . Four malunions were developed in the operative group and nineteen malunions in the nonoperative treatment , ( p<0.001 ) . Three patients in the operative group were completely dissatisfied with their treatment . Eighteen patients in the nonoperative group were partially satisfied . Pain was the main reason for dissatisfaction in this group . The mean shortening of the clavicle was 26.5 mm in the nonoperative group and 4.0 mm in the operative group . The mean DASH score for the operative and nonoperative groups were 8.6 and 21.3 , respectively ( p<0.001 ) ; and the Constant shoulder scores were 89.8 and 78.8 ( p<0.001 ) . CONCLUSION Open reduction and internal fixation of comminuted fractures of the clavicle using a reconstruction plate is an effective treatment modality . Despite the variety of complications , this method has a higher satisfaction rate than conservative treatment Background Clavicle fractures account for around 4 % of all fractures and up to 44 % of fractures of the shoulder girdle . Fractures of the middle third ( or mid-shaft ) account for approximately 80 % of all clavicle fractures . Management of this group of fractures is often challenging and the outcome can be unsatisfactory . In particular it is not clear whether surgery produces better outcomes than non-surgical management . Currently there is much variation in the use of surgery and a lack of good quality evidence to inform our decision . Methods / Design We aim to undertake a multicentre r and omised controlled trial evaluating the effectiveness and safety of conservative management versus open reduction and internal fixation for displaced mid-shaft clavicle fractures in adults . Surgical treatment will be performed using the Acumed clavicle fixation system . Conservative management will consist of immobilisation in a sling at the side in internal rotation for 6 weeks or until clinical or radiological union .  We aim to recruit 300 patients . These patients will be followed-up for at least 9 months . The primary endpoint will be the rate of non-union at 3 months following treatment . Secondary endpoints will be limb function measured using the Constant-Murley Score and the Disabilities of the Arm , Shoulder and H and ( DASH ) Score at 3 and 9 months post-operatively . Discussion This article presents the protocol for a multicentre r and omised controlled trial . It gives extensive details of , and the basis for , the chosen methods , and describes the key measures taken to avoid bias and to ensure validity . Trial Registration United Kingdom Clinical Research Network ID : 8665 . The date of registration of the trial is 07/09/2006 . The date the first patient was recruited is 18/12/2007 CONTEXT The Consoli date d St and ards for Reporting of Trials ( CONSORT ) statement was developed to help improve the quality of reports of r and omized controlled trials ( RCTs ) . To date , a paucity of data exists regarding whether it has achieved this goal . OBJECTIVE To determine whether use of the CONSORT statement is associated with improvement in the quality of reports of RCTs . DESIGN AND SETTING Comparative before- and -after evaluation in which reports of RCTs published in 1994 ( pre-CONSORT ) were compared with RCT reports from the same journals published in 1998 ( post-CONSORT ) . We included 211 reports from BMJ , JAMA , and The Lancet ( journals that adopted CONSORT ) as well as The New Engl and Journal of Medicine ( a journal that did not adopt CONSORT and was used as a comparator ) . MAIN OUTCOME MEASURES Number of CONSORT items included in a report , frequency of unclear reporting of allocation concealment , and overall trial quality score based on the Jadad scale , a 5-point quality assessment instrument . RESULTS Compared with 1994 , the number of CONSORT checklist items in reports of RCTs increased in all 4 journals in 1998 , and this increase was statistically significant for the 3 adopter journals ( pre-CONSORT , 23.4 ; mean change , 3.7 ; 95 % confidence interval [ CI ] , 2.1 - 5.3 ) . The frequency of unclear reporting of allocation concealment decreased for each of the 4 journals , and this change was statistically significant for adopters ( pre-CONSORT , 61 % ; mean change , -22 % ; 95 % CI , -38 % to -6 % ) . Similarly , 3 of the 4 journals showed an improvement in the quality score for reports of RCTs , and this increase was statistically significant for adopter journals overall ( pre-CONSORT , 2.7 ; mean change , 0.4 ; 95 % CI , 0.1 - 0.8 ) . CONCLUSION Use of the CONSORT statement is associated with improvements in the quality of reports of RCTs We conducted a prospect i ve , r and omized study to determine if patients with midshaft clavicle fractures would benefit from immediate operative stabilization with a modified Hagie pin in comparison with a matched group treated with nonoperative therapy . At a level II trauma center , patients with closed midshaft clavicle fractures were prospect ively r and omized to receive either operative or nonoperative treatment . Fifty-seven ( 29 operative , 28 nonoperative ) patients were enrolled in the study . Operative patients underwent open reduction and internal fixation of the clavicle using a modified Hagie pin ; nonoperative patients were treated with a sling for comfort . All patients were followed at regular intervals for 1 year . They were evaluated for radiographic healing and complications and were scored with the Single Assessment Numeric Evaluation and L'Insalata instruments .  Injury severities  and radiographs were not statistically significantly different between the 2 groups . Functional scores in the operative group were slightly higher at 3 weeks , and the nonoperative group had slightly higher scores at 6 months and 1 year . The only statistically significant difference between the groups was at 3 weeks . Percentage follow-up at 1 year was 93 % for the operative group and 82 % for the nonoperative group . One patient in each group developed a nonunion , and 1 patient in each group had a refracture . Complications were higher in the operative group , and most were related to pin prominence at the posterior shoulder . Results of this study suggest that , though patients with midshaft clavicle fractures had higher functional scores at short-term follow-up after internal fixation , functional scores were similar at 6 months and 1 year . In addition , internal fixation with a modified Hagie pin was associated with a higher complication rate BACKGROUND Recent literature supports surgical intervention for shortened , displaced , mid-shaft clavicle fractures . We present the results of a r and omized clinical trial comparing locked intramedullary fixation and plate fixation for short , displaced , mid-shaft clavicle fractures . MATERIAL S AND METHODS Local ethical approval was obtained and power analysis and sample size calculations were performed prior to commencement . Patients r and omized to 2 groups to be treated with either locked intramedullary fixation or plating .  Patients regularly followed up to clinical and radiographic union . The primary outcome measure was the Constant score , secondary outcome measures included the Oxford shoulder score , union rate , and complication rates . RESULTS Seventeen patients were r and omized to locked intramedullary fixation and 15 r and omized to plating . Mean age was 29.3 years . Mean follow-up was 12.4 months . There was no significant difference in either Constant scores ( P = .365 ) or Oxford scores ( P = .773 ) . There was 100 % union in both groups . In the intramedullary group , 1 case of soft tissue irritation settled after the pin removal ; 1 pin backed out and was revised . Three superficial wound infections result ed in plate removal and 8 plates ( 53 % ) were removed . DISCUSSION Intramedullary fixation has the theoretical advantage of preserving the periosteal blood supply , but carries the morbidity of pin removal . Clavicle plates are not routinely removed but require greater exposure and may compromise periosteal blood supply . CONCLUSION Both locked intramedullary fixation and plating produce good functional results ; however , metalwork may need to be removed as a second procedure BACKGROUND Time to union is a suspect measure for comparing treatments given the absence of a consensus definition of union , the limited reliability of diagnostic tests , and inconsistency in evaluation times . The purpose of this study was to quantify the variations in union and time to union according to different statistical methods and different approaches to missing data . MATERIAL S AND METHODS Data from a published multicenter , r and omized trial comparing operative and nonoperative treatment of clavicular fractures were reanalyzed . Two main types of missing data were encountered : ( 1 ) lost to follow-up or died before union and ( 2 ) missed appointment . We studied the effect of four statistical methods -comparison of means , comparison of medians , χ(2 ) , and Kaplan-Meier curves-for comparing union or time to union between cohorts for the following scenarios : strict intention-to-treat , intention-to-treat with exclusion of patients with less than 12 months of follow-up , as-treated analysis , and four different imputation methods for missing data . RESULTS Mean and median time to union varied up to 17 % , but comparative statistics consistently demonstrated shorter time to union among operatively treated patients . There were significant differences in the odds ratio , χ(2 ) values , and the number needed to treat ( 8%-62 % ) of union vs nonunion for the three principal analyses . CONCLUSION Different strategies for h and ling missed evaluations seem to influence categoric results ( eg , union or nonunion ) more than continuous measures such as time to union Objectives : To determine the cost-effectiveness of open reduction internal fixation ( ORIF ) of displaced , midshaft clavicle fractures in adults . Design : Formal cost-effectiveness analysis based on a prospect i ve , r and omized , controlled trial . Setting : Eight hospitals in Canada ( seven university-affiliated and one community hospital ) . Patients / Participants : One hundred thirty-two adults with acute , completely displaced , midshaft clavicle fractures . Intervention : Clavicle ORIF versus nonoperative treatment . Main Outcome Measurements : Utilities derived from SF-6D . Results : The base case cost per quality -adjusted life-year ( QALY ) gained for ORIF was $ 65,000 . Cost-effectiveness improved to $ 28,150/QALY gained when the functional benefit from ORIF was assumed to be permanent with cost per QALY gained falling below $ 50,000 when the functional advantage persisted for 9.3 years or more . In other sensitivity analyses , the cost per QALY gained for ORIF fell below $ 50,000 when ORIF cost less than $ 10,465 ( base case cost $ 13,668 ) or the long-term utility difference between nonoperative treatment and ORIF was greater than 0.034 ( base case difference 0.014 ) . Short-term disutility associated with fracture healing also affected cost-effectiveness with the cost per QALY gained for ORIF falling below $ 50,000 when the utility of a fracture treated nonoperatively before union was less than 0.617 ( base case utility 0.706 ) or when nonoperative treatment increased the time to union by 20 weeks ( base case difference 12 weeks ) . Conclusions : The cost-effectiveness of ORIF after acute clavicle fracture depended on the durability of functional advantage for ORIF compared with nonoperative treatment . When functional benefits persisted for more than 9 years , ORIF had a favorable value compared with many accepted health interventions Background The traditional view that the vast majority of midshaft clavicular fractures heal with good functional outcomes following non-operative treatment may be no longer valid for all midshaft clavicular fractures . Recent studies have presented a relatively high incidence of non-union and identified speciic limitations of the shoulder function in subgroups of patients with these injuries . Aim A prospect i ve , multicentre r and omised controlled trial ( RCT ) will be conducted in 21 hospitals in the Netherl and s , comparing fracture consolidation and shoulder function after either non-operative treatment with a sling or a plate fixation . Methods / design A total of 350 patients will be included , between 18 and 60 years of age , with a dislocated midshaft clavicular fracture . The primary outcome is the incidence of non-union , which will be determined with st and ardised X-rays ( Antero-Posterior and 30 degrees caudocephalad view ) . Secondary outcome will be the functional outcome , measured using the Constant Score . Strength of the shoulder muscles will be measured with a h and held dynamometer ( MicroFET2 ) . Furthermore , the health-related Quality of Life score ( ShortForm-36 ) and the Disabilities of Arm , Shoulder and H and ( DASH ) Outcome Measure will be monitored as subjective parameters . Data on complications , bone union , cosmetic aspects and use of painkillers will be collected with follow-up question naires . The follow-up time will be two years . All patients will 
    Output:
    
Conversely , stiffness or restriction of shoulder movement was more common after conservative treatment ( data from three trials ) .
Limited evidence is available from r and omised controlled trials on the relative effectiveness of surgical versus conservative treatment for acute middle third clavicle fractures .