***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: Background The primary aim of this study was to provide an estimate of effect size for the functional outcome of operative versus non-operative treatment for patients with an acute rupture of the Achilles tendon using accelerated rehabilitation for both groups of patients . The secondary aim was to assess the use of a comprehensive cohort research design ( i.e. a parallel patient-preference group alongside a r and omised group ) in improving the accuracy of this estimate within an orthopaedic trauma setting . Methods Pragmatic r and omised controlled trial and comprehensive cohort study within a level 1 trauma centre . Twenty r and omised participants ( 10 operative and 10 non-operative ) and 29 preference participants ( 3 operative and 26 non-operative ) . The ge range was 22 - 72 years and 37 of the 52 patients were men . All participants had an acute rupture of their Achilles tendon and no other injuries . All of the patients in the operative group had a simple end-to-end repair of the tendon with no augmentation . Both groups then followed the same eight-week immediate weight-bearing rehabilitation programme using an off-the-shelf orthotic .  The disability rating index ( DRI ; primary outcome ) , EQ-5D , Achilles Total Rupture Score and complications were assessed ed at two weeks , six weeks , three months , six months and nine months after initial injury . Results At nine months , there was no significant difference in DRI between patients r and omised to operative or non-operative management . There was no difference in DRI between the r and omised group and the parallel patient preference group . The use of a comprehensive cohort of patients did not provide useful additional information as to the treatment effect size because the majority of patients chose non-operative management . Conclusions Recruitment to clinical trials that compare operative and non-operative interventions is notoriously difficult ; especially within the trauma setting . Including a parallel patient preference group to create a comprehensive cohort of patients has been suggested as a way of increasing the power of such trials . In our study , the comprehensive cohort model doubled the number of patients involved in the study . However , a strong preference for non-operative treatment meant that the increased number of patients did not significantly increase the ability of the trial to detect a difference between the two interventions .Trial registration IS RCT N : IS RCT Objective To investigate whether surgery by open reduction and internal fixation provides benefit compared with non-operative treatment for displaced , intra-articular calcaneal fractures . Design Pragmatic , multicentre , two arm , parallel group , assessor blinded r and omised controlled trial ( UK Heel Fracture Trial ) . Setting 22 tertiary referral hospitals , United Kingdom . Participants 151 patients with acute displaced intra-articular calcaneal fractures r and omly allocated to operative ( n=73 ) or non-operative ( n=78 ) treatment . Main outcome measures The primary outcome measure was patient reported Kerr-Atkins score for pain and function ( scale 0 - 100 , 100 being the best possible score ) at two years after injury . Secondary outcomes were complications ; hindfoot pain and function ( American Orthopaedic Foot and Ankle Society score ) ; general health ( SF-36 ) ; quality of life ( EQ-5D ) ; clinical examination ; walking speed ; and gait symmetry . Analysis was by intention to treat . Results 95 % follow-up was achieved for the primary outcome ( 69 in operative group and 74 in non-operative group ) , and a complete set of secondary outcomes were available for 75 % of participants . There was no significant difference in the primary outcome ( mean Kerr-Atkins score 69.8 in operative group v 65.7 in non-operative group ; adjusted 95 % confidence interval of difference −7.1 to 7.0 ) or in any of the secondary outcomes between treatment groups . Complications and reoperations were more common in those who received operative care ( estimated odds ratio 7.5 , 95 % confidence interval 2.0 to 41.8 ) . Conclusions Operative treatment compared with non-operative care showed no symptomatic or functional advantage after two years in patients with typical displaced intra-articular fractures of the calcaneus , and the risk of complications was higher after surgery . Based on these findings , operative treatment by open reduction and internal fixation is not recommended for these fractures . Trial registration Current Controlled Trials IS RCT N37188541 OBJECTIVE To evaluate the clinical effectiveness of intraarticular IL-1 receptor antagonist ( IL-1Ra ) for anterior cruciate ligament ( ACL ) tear . METHODS Eleven patients with acute ACL tear confirmed by magnetic resonance imaging ( MRI ) were r and omized to receive a single intraarticular injection of IL-1Ra ( anakinra 150 mg , n = 6 ) or equal volume of saline placebo ( 1 ml , n = 5 ) . The double-blinded treatment was administered a mean 2 weeks after injury . Synovial fluid ( SF ) ( n = 9 patients ) and sera ( all patients ) were available at baseline ( prior to injection ) and immediately prior to surgery ( mean 35 days later ) and analyzed for SF IL-1α , IL-1β , IL-1Ra and serum hyaluronan ( HA ) , an indicator of synovial inflammation . The primary outcome , st and ardized Knee Injury and Osteoarthritis Outcome Score ( KOOS ) question naire , was obtained at 0 ( baseline ) , 4 , and 14 days after injection . RESULTS Compared with placebo , the IL-1Ra group had substantially greater improvement in key outcomes over 14 days ( KOOS pain P = 0.001 ; activities of daily living P = 0.0015 ; KOOS sports function P = 0.0026 ; KOOS quality of life ( QOL ) P = 0.0048 ; and total KOOS P < 0.0001 ) . There were no adverse reactions in either group . SF IL-1α ( P = 0.05 ) and serum HA ( P = 0.03 ) , but not IL-1β , or IL-1Ra , decreased significantly in the IL-1Ra but not the placebo treated patients . Compared with placebo , IL-1α was borderline significantly different in the IL-1Ra treated group ( P = 0.06 ) . CONCLUSIONS Administered within the first month following severe knee injury , IL-1Ra  reduced knee pain and improved function over a 2-week interval . This promising proof of concept study provides a new paradigm for studies of acute joint injury and suggests that a larger follow-up study is warranted Background The treatment and management of hip fracture poses a great challenge for clinicians in osteology and surgery . The aim of this study is to compare the clinical effectiveness of the percutaneous compression plate ( PCCP ) versus proximal femoral nail anti-rotation ( PFNA ) in the treatment of intertrochanteric fractures in elderly patients . Methods A prospect i ve r and omized study was carried out from January 2008 to October 2011 involving 90 elderly patients with intertrochanteric fractures ( 90 hips ) who underwent minimally invasive surgery using the PCCP or PFNA .  Evaluation variables , including operation time , intra- and perioperative blood loss , duration of hospital stay , incidence of postoperative complications , and final clinical outcomes by the end of follow-up , were used to compare the benefits of these two implants . Results Among 90 subjects , 45 received PCCPs and 45 received PFNAs . The baseline characteristics of the two groups were comparable . The median follow-up time was 16.9 months ( 12–24 months ) . In the PCCP group , the mean operative time was 53 min ( 40–75 min ) , and the mean intra- and perioperative blood losses were 100.7 ml ( 60–150 ml ) and 916 ml ( 433–1339 ml ) , respectively , which were significantly lower than those in the PFNA group . Nevertheless , there was no statistical difference in the incidence of postoperative complications and final clinical outcomes including pain complaints , range of motion of the hip , postoperative hip function at 12 months , and the recovery of walking ability to pre-injury status between these two implants . Conclusions Overall , the PCCP and PFNA appear to have similar clinical effects in treating elderly patients with intertrochanteric fractures , although the PCCP provided shorter operation times and less blood loss than PFNA . Both implants discussed were demonstrated to be ideal for the treatment of femoral intertrochanteric fractures in elderly patients Objective : To compare the effect of the Chignon ankle-foot orthosis on gait versus a st and ard ankle-foot orthosis . Method : A multicentre r and omized study was conducted in seven rehabilitation centres . Hemiplegic patients were recruited after unilateral stroke lasting less than six months . Exclusion criteria were : impossibility to st and for 10 seconds ; ankle passive dorsiflexion < 5 degrees with knee flexed to 90 degrees ; triceps spasticity ≥3/4 on the Ashworth modified scale ; diseases that might impair active participation in the study . Thirteen patients were r and omized to the Chignon group and 15 to the control group . Included patients were given a st and ard ankle-foot orthosis or Chignon ankle-foot orthosis . The Chignon ankle-foot orthosis is an articulated double-stopped custom-made orthosis with elements to assist dorsiflexion and plantar flexion . Gait speed improvement ( ten-metre test ) , kinematic assessment , and functional scales were assessed . Results : Gain ratio of walking speed with the  orthosis increased significantly more in the Chignon group than in the control group at day 0 ( 27.2 ± 36 % versus −0.8 ± 17 % ; P = 0.006 ) , day 30 ( 39.9 ± 19 % versus 7.5 ± 17 % ; P = 0.0004 ) and day 90 ( 44.6 ± 27 % versus 17.1 ± 0.3 % ; P = 0.04 ) . There was also a significant improvement in kinematic parameters and spasticity in the Chignon group . Conclusion : Early compensation of distal motor deficiency by the Chignon ankle-foot orthosis improves the immediate gait of hemiplegics more than the st and ard ankle-foot orthosis and seems to modify motor recovery processes in the legs after stroke Background There is no consensus about the optimal time for weightbearing activities after matrix-associated autologous chon-drocyte implantation ( MACI ) of the femoral condyle . Hypothesis A comprehensive protocol after MACI on the femoral condyle with accelerated weightbearing leads to a better functional and radiographic outcome compared with the same comprehensive protocol with delayed weightbearing . Study Design R and omized controlled trial ; Level of evidence , 1 . Methods Thirty-one patients ( 22 male , 9 female ) after MACI on the femoral condyle were r and omly assigned to the  accelerated weightbearing group ( group A ) or the  delayed weightbearing group ( group B ) . Aside from increase and time of full weightbearing , both groups adhered to the same rehabilitation protocol and exercises . Patients were assessed preoperatively and at 4 , 12 , 24 , 52 , and 104 weeks after surgery . Clinical evaluation was performed by determining the subjective form of the International Knee Documentation Committee ( IKDC ) , the Tegner activity scale , and the Knee Injury and Osteoarthritis Outcome Score ( KOOS ) . Radiological outcome was evaluated by the MOCART score and the size and amount of bone marrow edema and effusion . Results In both groups , there were no differences with regard to the clinical outcome . For the radiological outcome , group A showed a higher prevalence of bone marrow edema after 6 months without correlation to the clinical outcome ( P 5 .06-.1 ) . However , after 104 weeks , there were no differences in the radiological outcome between group A and group B. Conclusion A rehabilitation protocol with accelerated weightbearing leads to good clinical and functional outcome after 2 years without jeopardizing the healing graft The objective of this study is to compare the clinical and radiographic results of ultraporous β-tricalcium phosphate ( β-TCP ) versus autogenous iliac crest bone graft ( ICBG ) , through prospect i ve r and omized pilot study ( EBM-Level 1 ) , as graft extenders in scoliosis surgery . In the posterior correction of scoliosis , local bone resected as part of the procedure is used as the base bone graft material . Supplemental grafting from the iliac crest is considered the gold-st and ard in posterior spinal fusion . However , autograft is not available in unlimited quantities , and bone harvesting is a source of significant morbidity . Ultraporous β-TCP might be a substitute for ICBG in these patients and thus eliminate donor site morbidity . A total of 40 patients with adolescent idiopathic scoliosis ( AIS ) were r and omized into two treatment groups and underwent corrective posterior instrumentation . In 20 patients , ICBG harvesting was performed whereas the other half received β-TCP ( VITOSS ® ) to augment the local bone graft . If thoracoplasty was performed , the resected rib bone was added in both groups . Patients were observed clinical ly and radiographically for a minimum of 20 months postoperatively , with a mean follow-up of 4 years . Overall pain and pain specific to the back and donor site were assessed using a visual analog scale ( VAS ) . As a result , both groups were comparable with respect to the age at 
    Output:
    
Conclusions Based on this systematic review , most pilot RCTs were characterized as feasibility trials .
However , the majority of published pilot RCTs did not lead to definitive trials .
This discrepancy was mainly attributed to poor feasibility ( e.g. poor recruitment ) and lack of funding for an orthopaedic surgical definitive trial .