Determination of minimum clinically important difference (MCID) in pain,disability, and quality of life after revision fusion for symptomatic pseudoarthrosis

Background contextSpinal surgical outcome studies rely on patient reported outcome (PRO) measurements to assess the effect of treatment. A shortcoming of these questionnaires is that the extent of improvement in their numerical scores lacks a direct clinical meaning. As a result, the concept of minimum clinically important difference (MCID) has been used to measure the critical threshold needed to achieve clinically relevant treatment effectiveness. Post hoc anchor-based MCID methods have not been applied to the surgical treatment for pseudoarthrosis.PurposeTo determine the most appropriate MCID values for visual analog scale (VAS), Oswestry Disability Index (ODI), Short Form (SF)-12 physical component score (PCS), and European Quality of Life 5-Dimensions (EQ-5D) in patients undergoing revision lumbar arthrodesis for symptomatic pseudoarthrosis.Study design/ settingRetrospective cohort study.MethodsIn 47 patients undergoing revision fusion for pseudoarthrosis-associated back pain, PRO measures of back pain (BP-VAS), ODI, physical quality of life (SF-12 PCS), and general health utility (EQ-5D) were assessed preoperatively and 2 years postoperatively. Four subjective post hoc anchor-based MCID calculation methods were used to calculate MCID (average change; minimum detectable change; change difference; and receiver operating characteristic curve analysis) for two separate anchors (health transition index (HTI) of SF-36 and satisfaction index).ResultsAll patients were available for a 2-year PRO assessment. Two years after surgery, a significant improvement was observed for all PROs; Mean change score: BP-VAS (2.3±2.6; p<.001), ODI (8.6%±13.2%; p<.001), SF-12 PCS (4.0±6.1; p=.01), and EQ-5D (0.18±0.19; p<.001). The four MCID calculation methods generated a wide range of MCID values for each of the PROs (BP-VAS: 2.0–3.2; ODI: 4.0%–16.6%; SF-12 PCS: 3.2–6.1; and EQ-5D: 0.14–0.24). There was no difference in response between anchors for any patient, suggesting that HTI and satisfaction anchors are equivalent in this patient population. The wide variations in calculated MCID values between methods precluded any ability to reliably determine what the true value is for meaningful change in this disease state.ConclusionsUsing subjective post hoc anchor-based methods of MCID calculation, MCID after revision fusion for pseudoarthrosis varies by as much as 400% per PRO based on the calculation technique. MCID was suggested to be as low as 2 points for ODI and 3 points for SF-12. These wide variations and low values of MCID question the face validity of such calculation techniques, especially when applied to heterogeneous disease and patient groups with a multitude of psychosocial confounders such as failed back syndromes. The variability of MCID thresholds observed in our study of patients undergoing revision lumbar fusion for pseudoarthrosis raises further questions to whether ante hoc or Delphi methods may be a more valid and consistent technique to define clinically meaningful, patient-centered changes in PRO measurements.     

An economic analysis of management strategies for closed and open grade I tibial shaft fractures

Background?Closed and open grade I (low-energy) tibial shaft fractures are a common and costly event, and the optimal management for such injuries remains uncertain.

Methods?We explored costs associated with treatment of low-energy tibial fractures with either casting, casting with therapeutic ultrasound, or intramedullary nailing (with and without reaming) by use of a decision tree.

Results?From a governmental perspective, the mean associated costs were USD 3,400 for operative management by reamed intramedullary nailing, USD 5,000 for operative management by non-reamed intramedullary nailing, USD 5,000 for casting, and USD 5,300 for casting with therapeutic ultrasound. With respect to the financial burden to society, the mean associated costs were USD 12,500 for reamed intramedullary nailing, USD 13,300 for casting with therapeutic ultrasound, USD 15,600 for operative management by non-reamed intramedullary nailing, and USD 17,300 for casting alone.

Interpretation?Our analysis suggests that, from an economic standpoint, reamed intramedullary nailing is the treatment of choice for closed and open grade I tibial shaft fractures. Considering financial burden to society, there is preliminary evidence that treatment of low-energy tibial fractures with therapeutic ultrasound and casting may also be an economically sound intervention.     

A Weighted Scoring System Based on Preoperative and Long-Term Patient-Reported Outcome Measures to Guide Timing of Knee Arthroplasty

BackgroundThere is currently no existing consensus regarding timing of knee arthroplasty. This study aimed to develop a weighted scoring system from patient-reported outcome measures (PROMs) to guide timing of knee arthroplasty based on preoperative severity and long-term effectiveness.MethodsProspectively collected data of 766 total knee arthroplasties (TKAs) and 382 unicompartmental knee arthroplasties (UKAs) at a single institution were analyzed. PROMs were assessed preoperatively and at 10 years using the Knee Society Score (KSS), Oxford Knee Score (OKS), and Short Form-36 physical component score (SF-36 PCS). Receiver operating characteristic analysis identified thresholds where preoperative PROMs predicted 10-year clinically meaningful improvements (minimal clinically important difference [MCID]). Threshold weights were assigned to PROMs based on their ability to predict MCID in isolation or in combination.ResultsPoorer baseline PROMs predicted 10-year MCID attainments. The threshold of 49.5 points for the KSS, 30.5 points for the OKS, and 40.7 points for the SF-36 PCS and 55.5 points for the KSS, 33.5 points for the OKS, and 40.5 points for the SF-36 PCS was weighted 1 point for predicting MCID in 1 PROM for TKA and UKA, respectively. The threshold of 33.4 and 33.9 points for the SF-36 PCS was weighted 2 points for predicting MCID in 2 PROMs, whereas 29.3 and 31.3 points for the SF-36 PCS were weighted 3 points for predicting MCID in 3 PROMs for TKA and UKA, respectively. The sum of weighted components from 0 (lowest) to 5 (highest) represented likelihood for long-term benefits at 10 years.ConclusionThis scoring system is a useful clinical adjunct for deciding timing of knee arthroplasty and prioritizing patients in institutions with long waitlists.Level of EvidenceII.     

Current management of tibial shaft fractures: A survey of 450 Canadian orthopedic trauma surgeons

Background and purpose?Strategies to manage tibial fractures include nonoperative and operative approaches. Strategies to enhance healing include a variety of bone stimulators. It is not known what forms of management for tibial fractures predominate among Canadian orthopedic surgeons. We therefore asked a representative sample of orthopedic trauma surgeons about their management of tibial fracture patients.

Methods?This was a cross-sectional survey of 450 Canadian orthopedic trauma surgeons. We inquired about demographic variables and current tibial shaft fracture management strategies.

Results?268 surgeons completed the survey, a response rate of 60%. Most respondents (80%) managed closed tibial shaft fracture operatively; 47% preferred reamed intramedullary nailing and 40% preferred unreamed. For open tibial shaft fractures, 59% of surgeons preferred reamed intramedullary nailing. Some surgeons (16%) reported use of bone stimulators for management of uncomplicated open and closed tibial shaft fractures, and almost half (45%) made use of this adjunctive modality for complicated tibial shaft fractures. Low-intensity pulsed ultrasound and electrical stimulation proved equally popular (21% each) and 80% of respondents felt that a reduction in healing time of 6 weeks or more, attributed to a bone stimulator, would be clinically important.

Interpretation?Current practice regarding orthopedic management of tibial shaft fractures in Canada strongly favors operative treatment with intramedullary nailing, although respondents were divided in their preference for reamed and unreamed nailing. Use of bone stimulators is common as an adjunctive modality in this injury population. Large randomized trials are needed to provide better evidence to guide clinical decision making regarding the choice of reamed or unreamed nailing for tibial shaft fractures, and to inform surgeons about the actual effect of bone stimulators.     

LCP钢板和带锁髓内钉治疗新鲜胫骨干骨折的对比研究

目的回顾性分析LCP钢板和带锁髓内钉两种方法治疗新鲜胫骨干骨折的效果。方法2003年10月～2006年4月,收治55例胫骨干新鲜骨折患者。其中男39例,女16例;年龄14～62岁,平均39岁。左侧27例,右侧31例,其中3例为双侧。34处骨折采用带锁髓内钉固定治疗(髓内钉组),24处骨折给予LCP钢板内固定治疗(LCP组)。髓内钉组和LCP组伤后至手术时间分别平均为3d和3.1d。评估两组患者手术时间、膝、踝关节活动度、骨折愈合时间以及术后并发症。结果术后获随访8～26个月,平均13个月。手术时间髓内钉组为84.0±9.2min,LCP组为69.0±8.4min;平均住院费髓内钉组为19297.78元,LCP组为14116.55元,差异均有统计学意义(P<0.05)。髓内钉组膝关节屈曲为139.0±3.7°,LCP组为149.0±4.2°,伸直分别为4.0±0.7°和0±0.4°,差异均无统计学意义(P>0.05)。髓内钉组、LCP组踝关节背屈分别为13.0±1.7°、10.0±1.4°,跖屈分别为41.0±2.6°、44.0±2.3°,差异均无统计学意义(P>0.05)。骨折愈合时间LCP组略早,平均为3.1个月;髓内钉组平均为3.3个月。髓内钉组术后X线片示1例下肢短缩2.5cm,1例骨折延迟愈合,3例钉尾问题,1例旋转畸形(20°),6例膝前疼痛;LCP组1例开放骨折(AO分型为42B型)的患者术后1周发生感染,1例胫骨远端1/3骨折出现成角畸形。结论带锁髓内钉和LCP钢板内固定治疗胫骨骨折均可取得理想效果。两种方法在膝关节和踝关节背屈度及跖屈度方面影响很小,都可保证骨折愈合。LCP钢板内固定并发症较少,且在手术时间和住院费用上更加有优势。     

Operative management of lower extremity fractures in patients with head injuries

Treatment of patients with lower extremity fractures and concomitant head injury is controversial. The authors compared reamed intramedullary nailing versus plating of femoral and tibial fractures in patients with polytrauma and concomitant head injury. One thousand five hundred twenty-five patients with head injuries were identified from a prospective trauma database. Of those, 1211 patients sustained severe head injuries (Abbreviated Injury Score >/= 3). One hundred nineteen patients with severe head injuries and lower extremity long bone fractures met the inclusion criteria. Ultimately, four patient groups were identified: Group A, reamed femoral nail (n = 21); Group B, femoral plate (n = 29); Group C, reamed tibial nail (n = 23); and Group D, tibial plate (n = 46). Reamed intramedullary nails did not significantly alter the risk of mortality when compared with plates in femoral (relative risk 0.46; 95% confidence interval, 0.04-4.6) and tibial (relative risk 1.18; 95% confidence interval, 0.05-11.9) fractures. The severity of the initial head injury (Glasgow Coma Scale score) was the strongest predictor of mortality. Functional independence scores between patients with reamed nails and patients with plates were similar at 1 year. Head injury does not seem to be a contraindication to reamed intramedullary nailing in patients with lower extremity fractures. The severity of head injury alone is an important predictor of outcome. A large, randomized trial with sufficient study power is needed to clarify this issue.     

胫骨近端关节外骨折髓内钉治疗与钢板固定治疗的比较

Limited, poor evidence is available for comparing the treatment of extraarticular proximal tibial fractures by intramedullary nail or plate fixation. There was no difference in the rates of nonunion for either treatment. Significantly less patients treated by intramedullary nailing experience infection than patients treated by plating, whereas more patients treated by intramedullary nailing experienced malunion or compartment syndrome than those treated by intramedullary nailing. Implant failure occurred only in patients treated by intramedullary nailing. However,definitive conclusions cannot be drawn from this collection of case-series and a well-conducted prospective or randomized controlled trial would be a significant addition to this subject.     

Permanent reduction plate and intramedullary nailing of open tibia fractures: Do we need to take them out?

IntroductionProvisional reduction plating has been advocated as a reduction aid for tibial shaft fractures. Concerns regarding soft tissue stripping, infection, wound complications and nonunion have been postulated. Recent studies investigating reduction plating present patient cohorts where plates are removed or left to the discretion of the surgeon. This study aims to identify a cohort of open tibial shaft fractures treated with intramedullary nailing aided by permanent reduction plating. Our hypothesis is that permanent reduction plating in conjunction with intramedullary nailing of open tibia fractures does not increase risk of nonunion, infection or time to fracture union compared to intramedullary nailing alone.MethodsAn IRB approved retrospective study was performed using trauma registry data from January 2014 to June 2018 at a Level 1 trauma center. Open AO/OTA 41A/42 A-C/43A tibial shaft fractures treated with intramedullary nail alone (IM) or intramedullary nail and permanent reduction plates (PP) were included in patients over 18 years of age with at least six month follow up or until fracture union. Patient demographics, fracture characteristics, mechanism of injury, medical comorbidities, and length of follow up were recorded along with time to union, incidence of nonunion and treatment for documented or suspected infections.ResultsDuring the study period, 389 patients underwent tibial intramedullary nailing with 162 identified as open fractures. 91 patients met inclusion criteria with 39 in the PP group and 52 in IM group. Statistical analysis revealed no difference between the two groups except more AO/OTA 42A fractures were noted in the IM group. Average follow up was 8.0 and 10.2 months for PP and IM respectively. Nonunion occurred in 2 PP group patients and 7 in the IM group (p = 0.29). Time to union was 5.5 months for PP group and 6.1 months for IM group (p = 0.39) with 4 infections in the PP group and 10 infections in IM group (p = 0.38).ConclusionDespite the small sample size, this study suggests that permanent reduction plating, in the setting of open tibia fractures, does not delay time to fracture union or increase risk of nonunion or infection.     

Validating the VR-12 Physical Function Instrument After Anterior Cervical Discectomy and Fusion with SF-12, PROMIS,and NDI

Background

Development and validation of Veterans RAND 12-item (VR-12) physical component survey (PCS) has been established among civilian and veteran populations but it has not been examined among anterior cervical discectomy and fusion (ACDF) patients.

Purposes/Questions

We sought to validate legacy patient-reported outcome measures (PROMs) with VR-12 PCS among patients undergoing ACDF procedures.

Methods

A prospectively collected surgical registry was retrospectively evaluated for elective single or multi-level ACDFs performed for degenerative spinal pathologies from January 2014 to August 2019. Exclusion criteria included missing pre-operative surveys and surgery for trauma, metastasis, or infection. Demographic variables, baseline pathologies, and peri-operative variables were collected. A paired t test evaluated the change from the pre-operative score to each post-operative timepoint for VR-12 PCS, the 12-item Short-Form Survey (SF-12) PCS, Patient-Reported Outcomes Measurement Information System physical function (PROMIS-PF), and Neck Disability Index (NDI). Minimal clinically important difference (MCID) achievement was calculated at each timepoint. Correlation was evaluated with a Pearson’s correlation coefficient and time-independent partial correlation.

Results

Of the 202 patients who underwent ACDF, 41.1% were female and the average age was 49.5 years. All PROMs had statistically significantly increased from baseline when compared with post-operative timepoints (12 weeks, 6 months, 1 year, and 2 years). MCID achievement rates increased through 2 years. All timepoints revealed strong VR-12 PCS correlations with SF-12 PCS, PROMIS-PF, and NDI scores.

Conclusion

VR-12 PCS was strongly correlated with the well-validated SF-12 PCS and NDI metrics as well as with the more recent PROMIS-PF. All PROMs demonstrated statistically significant improvement in patients post-operatively. VR-12 PCS is a valid measure of physical function among patients undergoing ACDF.

     

Neck Disability Index,short form-36 physical component summary,and pain scales for neck and arm pain: the minimum clinically important difference and substantial clinical benefit after cervical spine fusion

Background ContextThe Neck Disability Index (NDI), the short form-36 (SF-36) physical component summary (PCS), and pain scales for arm and neck pain are increasingly used to evaluate treatment effectiveness after cervical spine surgery. The minimum clinically important difference (MCID) is a threshold of improvement that is clinically relevant to the patient. However, the true goal is to provide the patient with a substantial clinical benefit (SCB).PurposeThis study determines the MCID and SCB using common anchor-based methods for NDI, PCS, and pain scales for arm and neck pain in patients undergoing cervical spine fusion for degenerative disorders.Study Design/SettingThe study setting is a longitudinal cohort in a multisurgeon spine specialty clinic.Patient sampleThe sample comprises 505 patients who underwent a cervical fusion for degenerative spine conditions and who have prospectively collected outcome scores with a minimum 1-year follow-up.Outcome MeasuresThe outcome measures of the study were NDI, SF-36, and numeric rating scales for arm and neck pain.MethodsThe MCID and SCB values for NDI, PCS, and pain scales for arm and neck pain were determined using receiver operating characteristic (ROC) curve analysis with the Health Transition Item of the SF-36 as an anchor. The Health Transition Item asks a patient “Compared to one year ago, how would you rate your health in general now?” with answers ranging from “Much Better,” “Somewhat Better,” “About the Same,” “Somewhat Worse,” to “Much Worse.” An ROC curve was constructed for each measure. The ROC curve–derived MCID was the change score with equal sensitivity and specificity to distinguish the “Somewhat Better” from the “About the Same” patients. The ROC curve–derived SCB was the change score with equal sensitivity and specificity to distinguish the “Much Better” from the “Somewhat Better” patients. Distribution-based methods including the standard error of the mean and the minimum detectable change were also used to calculate MCID.ResultsThe calculated MCID is 7.5 for the NDI, 4.1 for SF-36 PCS, and 2.5 for arm and neck pain. The calculated SCB is 9.5 for the NDI, 6.5 for SF-36 PCS, and 3.5 for arm and neck pain.ConclusionsPatients with an eight-point decrease in NDI, a 4.1-point increase in PCS, and a three-point decrease in arm or neck pain can detect a minimally clinically important change. Patients with a 10-point decrease in NDI, a 6.5-point increase in PCS, and a four-point decrease in arm or neck pain can detect an SCB after cervical spine fusion.     

Is device-assisted reduction prior to semi-extended intramedullary nailing of distal tibial fractures necessary?

IntroductionTraditional methods of nailing distal tibial fractures have an unacceptable risk of mal-alignment due to difficulty in obtaining and maintaining reduction intra-operatively. Methods to obtain and maintain reduction when nailing these fractures, and therefore reducing the risk of Mal-alignment include modified external fixators, distractors and commercial reduction tools. Semi-extended intramedullary nailing of distal tibial fractures via a supra-patellar approach is now being used more commonly. The aim of this study was to assess whether a commercial reduction device (Staffordshire Orthopaedic Reduction Machine − STORM, Intelligent Orthopaedics, Stafffordshire, UK) is necessary to reduce the risk of mal-alignment in patients undergoing semi-extended nailing for distal tibial fractures.MethodologyA case-control study was conducted in 20 patients who had STORM-assisted reduction of distal tibial fractures prior to intramedullary nailing and 20 controls without STORM. The control group was matched for age, sex, fracture type (AO/OTA), ASA and gender. All patients had an intramedullary nail (IMN) using the semi-extended system. Primary outcome measures were coronal and sagittal mal-alignment. Secondary outcome measure was unplanned return to theatre for complications and problems with fracture healing.ResultsThere was no difference in post-operative mal-alignment in both groups. There was no significant difference in time to union in both groups Both groups had equal number of patients requiring unplanned return to theatre. The STORM group was associated with a significantly increased operative time [p = 0.007, 130.3 min (SD 49.4) STORM vs 95.6 mins (SD 22.9) Control].ConclusionIntraoperative use of STORM significantly increases operative time with no difference in outcome. The superior orthogonal views and manual control obtained during semi-extended nailing via a supra-patellar approach obviate the need for additional methods: of intraoperative reduction for this fracture group.     

Intramedullary nailing of distal metaphyseal tibial fractures

BACKGROUND: The treatment of distal metaphyseal tibial fractures remains controversial. This study was performed to evaluate the results of intramedullary nailing of distal tibial fractures located within 5 cm of the ankle joint. METHODS: Over a sixteen-month period at two institutions, thirty-six tibial fractures that involved the distal 5 cm of the tibia were treated with reamed intramedullary nailing with use of either two or three distal interlocking screws. Ten fractures with articular extension were treated with supplementary screw fixation prior to the intramedullary nailing. Radiographs were reviewed to determine the immediate and final alignments and fracture-healing. The Short Form-36 (SF-36) and Musculoskeletal Function Assessment (MFA) questionnaires were used to evaluate functional outcome. RESULTS: Acceptable radiographic alignment, defined as <5 degrees of angulation in any plane, was obtained in thirty-three patients (92%). No patient had any change in alignment between the immediate postoperative and the final radiographic evaluation. Complications included one deep infection and one iatrogenic fracture at the time of the intramedullary nailing. Six patients could not be followed. The remaining thirty fractures united at an average of 23.5 weeks. Three patients with associated traumatic bone loss underwent a staged autograft procedure, and they had fracture-healing at an average of 44.3 weeks. The functional outcome was determined at a minimum of one year for nineteen patients and at a minimum of two years (average, 4.5 years) for fifteen patients. At one year, there were significant limitations in several domains despite fracture union and maintenance of alignment, but there was improvement in the MFA scores with time. CONCLUSIONS: Intramedullary nailing is an effective alternative for the treatment of distal metaphyseal tibial fractures. Simple articular extension of the fracture is not a contraindication to intramedullary fixation. Functional outcomes improve with time.     

Nail insertion points in semi-extended nailing of tibial fractures and their influence on alignment: A retrospective cohort study comparing two nail insertion techniques

IntroductionSemi-extended tibial nailing techniques include the extra-articular technique (EAT) and the patellar eversion technique (PET). These approaches differ regarding the exposure of the patellar retinaculum and the size of the surgical field. This study compared the postoperative alignment and intramedullary nailing entry points between the EAT and PET for tibial fractures.Patients and methodsA total of 54 patients (aged ≥18 years) who had undergone intramedullary nailing by the EAT (n = 29) or PET (n = 25) for a tibial shaft fracture were evaluated. The intramedullary nailing entry point and postoperative alignment were measured, and the 1-year postoperative follow-up results were compared.ResultsFor the EAT and PET, the intramedullary nailing entry point was located at a mean distance of 4.04 mm medial to the optimal entry point and 0.27 mm lateral to the optimal entry point, respectively. The mean angular deformation observed in anteroposterior radiographs following surgery using the EAT and PET were 2.49° and 0.32° valgus, respectively.ConclusionThe intramedullary nailing entry point affected postoperative alignment. Intramedullary nailing may result in malalignment while performing the EAT due to the interference of the patella at the time of nailing.     

Are Oxford Hip Score and Western Ontario and McMaster Universities Osteoarthritis Index Useful Predictors of Clinical Meaningful Improvement and Satisfaction After Total Hip Arthroplasty?

BackgroundUp to 15% of patients express dissatisfaction after total hip arthroplasty (THA). Preoperative patient-report outcome measures (PROMs) scores can potentially mitigate this by predicting postoperative satisfaction, identifying patients that will benefit most from surgery. The aim of this study was to (1) calculate the minimal clinically important difference (MCID) thresholds for Oxford Hip Score (OHS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Short Form-36 (SF-36) mental component summary (MCS) and physical component summary (PCS) scores and (2) identify the threshold values of these PROMs that could be used to predict patient satisfaction and expectation fulfilment.MethodsProspectively collected registry data of 1334 primary THA patients who returned for 2-year follow-up from 1998 to 2016 were reviewed. All patients were assessed preoperatively and postoperatively at 2 years using the OHS, WOMAC, and SF-36 PCS/MCS scores. The MCID for each PROMs was calculated, and the proportion of patients that attained MCID was recorded. The relationship between satisfaction, expectation fulfilment, and MCID attainment was analyzed using Spearman rank correlation. Optimal threshold scores for each PROM that predicted MCID attainment and satisfaction/expectation fulfilment at 2 years were calculated using receiver operating curve analysis.ResultsThe calculated MCID for OHS, WOMAC, SF-36 PCS, and SF-36 MCS were 5.2, 10.8, 6.7, and 6.2, respectively. A threshold value of 24.5 for the preoperative OHS was predictive of achieving WOMAC MCID at 2 years after THA (area under the curve 0.80, P < .001). 93.1% of patients were satisfied, and 95.5% had expectations fulfilled at 2 years. None of the PROMs were able to predict satisfaction.ConclusionOHS and WOMAC scores can be used to determine clinical meaningful improvement but are limited in their ability to predict patient satisfaction after THA.     

胫骨干骨折带锁髓内钉固定和钢板螺钉固定的对比研究

目的：对照回顾性分析带锁髓内钉和钢板内固定两种方法治疗胫骨干骨折的效果。方法：髓内钉组32例（35处骨折）,根据AO分型,42A型11处,42B型18处,42C型6处;钢板组42例（45处骨折）,42A型10处,42B型22处,42C型13处。平均伤后手术时间在髓内钉和钢板组分别为3d和3.5d。随访评估患者手术时间,活动度,愈合时间,术后并发症之间的差别。结果：术后平均随访13个月（8～26个月）。髓内钉组平均手术时间为84min,钢板螺钉组平均为93min。髓内钉组踝关节平均背屈度为13°（0°～20°）,钢板组为11°（0°～20°）;跖屈分别为41°（30°～50°）,47°（30°～50°）。愈合时间髓内钉组平均为3.3个月,钢板螺钉平均为3.5个月。术后X线片显示髓内钉固定有1例出现旋转畸形,钢板组有3例出现成角畸形,均为胫骨远端1/3骨折。结论：在治疗胫骨骨折方面,带锁髓内钉和钢板内固定两种方法都可以取得理想的效果。     

Conservative management or closed nailing for tibial shaft fractures. A randomised prospective trial

We performed a prospective randomised trial on matched groups of patients with displaced tibial shaft fractures to compare conservative treatment with closed intramedullary nailing. The results showed conclusively that intramedullary nailing gave more rapid union with less malunion and shortening. Nailed patients had less time off work with a more predictable and rapid return to full function. We therefore consider that closed intramedullary nailing is the most efficient treatment for displaced fractures of the tibial shaft.     

交锁髓内钉与加压钢板固定治疗胫骨骨折的疗效对比分析

目的评价交锁髓内钉与加压钢板固定两种疗法治疗胫骨骨折的疗效。方法将108例胫骨骨折患者随机采用交锁髓内钉或加压钢板固定治疗;观察两种方法的疗效、并发症。结果临床疗效:交锁髓内钉组优48例,加压钢板组优39例,x2=4.79,P<0.05;并发症:交锁髓内钉组7例,加压钢板组18例,x2=6.30,P<0.05。结论与加压钢板内固定治疗胫骨骨折相比,交锁髓内钉固定治疗胫骨骨折具有创伤小,功能恢复快,固定稳定性好,愈合率高、感染率低等优点,疗效满意,可以作为临床上优选方案之一。     

A prospective, randomized clinical trial comparing tibial nailing using fracture table traction versus manual traction.

OBJECTIVE: We sought to determine the effectiveness of intramedullary tibial nailing using manual traction with the leg draped free versus standard fracture table positioning and traction. STUDY DESIGN: Prospective, randomized clinical trial. METHODS: Eighty-five tibial shaft fractures (in seventy-nine patients) treated by intramedullary nailing were randomized either to manual traction with the leg draped free or to standard fracture table traction applied through a boot attachment. RESULTS: We found that manual traction provided results, in terms of intraoperative parameters and quality of fracture reduction, similar to those with standard fracture table traction. Manual traction significantly reduced positioning time (twelve minutes versus twenty-five minutes, p = 0.002) and also allowed for multiple simultaneous or sequential procedures in polytrauma patients without the need for re-positioning or re-draping. This saved a further thirty-two minutes (mean) in 37 percent of cases treated by manual traction. CONCLUSION: Manual traction for intramedullary nailing of the tibia is an effective technique that can save a significant amount of time without sacrificing the quality of reduction or fixation of tibial shaft fractures. It is especially useful in polytrauma patients with multiple lower-extremity injuries.     

An economic analysis of management strategies for closed and open grade I tibial shaft fractures

Background Closed and open grade I (low-energy) tibial shaft fractures are a common and costly event, and the optimal management for such injuries remains uncertain.

Methods We explored costs associated with treatment of low-energy tibial fractures with either casting, casting with therapeutic ultrasound, or intramedullary nailing (with and without reaming) by use of a decision tree.

Results From a governmental perspective, the mean associated costs were USD 3,400 for operative management by reamed intramedullary nailing, USD 5,000 for operative management by non-reamed intramedullary nailing, USD 5,000 for casting, and USD 5,300 for casting with therapeutic ultrasound. With respect to the financial burden to society, the mean associated costs were USD 12,500 for reamed intramedullary nailing, USD 13,300 for casting with therapeutic ultrasound, USD 15,600 for operative management by non-reamed intramedullary nailing, and USD 17,300 for casting alone.

Interpretation Our analysis suggests that, from an economic standpoint, reamed intramedullary nailing is the treatment of choice for closed and open grade I tibial shaft fractures. Considering financial burden to society, there is preliminary evidence that treatment of low-energy tibial fractures with therapeutic ultrasound and casting may also be an economically sound intervention.     

Eight years' clinical experience with the Orthofix tibial nailing system in the treatment of tibial shaft fractures

Intramedullary nailing has become a popular and effective procedure for the treatment of most tibial fractures. However, concerns regarding difficulties with reduction, the use and extent of intramedullary reaming, and hardware failure are probably the only constraints to its widespread use. In this prospective study, we present the clinical and radiographic results of the Orthofix tibial nailing system used in the treatment of tibial shaft fractures. One hundred and fifteen fresh tibial fractures in the same number of patients with a mean age of 37.5 years (17-85 years) were treated with operative stabilisation using the Orthofix tibial nailing system. All of the operations took place in a conventional operating theatre, on a simple tranlucent operating table and with manual reduction of the fracture. In the majority of the cases closed reduction and conventional reaming were performed and the mean duration of the operation was 38 min. Fracture healing occurred at 16 weeks (11-30 weeks) and was confirmed both clinically and radiographically. In six cases (two severely comminuted and four segmental fractures) delayed union occurred, however there were no tibial non-unions necessitating re-operation. There were no substantial differences in time to fracture union or in the rate of complications related to minimal open reduction. In addition, there seem to be more benefits than risks in the use of power intramedullary reaming during intramedullary fixation of tibial shaft fractures. In conclusion, most tibial shaft fractures can effectively and safely be treated using this type of locking intramedullary nailing device, with relatively few complications, and with satisfactory long-term clinical results.