Purpose: Unbiased outcome assessment in orthopedic clinical trials has the potential to improve trial validity. The approaches used to limit bias in outcome assessment in orthopaedic trials remain unclear. The objective of this systematic review was to assess the reporting and process of outcomes assessment practices in the current orthopaedic trauma literature.

Method: We searched eight high-impact-factor medical and orthopaedic journals manually and using the MED-LINE electronic database for reports of randomized controlled trials published from 2005 to 2008 pertaining to the surgical treatment of trauma-related injuries. Two reviewers independently determined study eligibility and extracted relevant data from included trials.

Results: Of the 7910 citations identified during our search, 47 randomized controlled trials, which included a total of 4706 patients, met our inclusion criteria. Of 47 studies, 39 (83%) provided a statement to describe some process of outcome assessment and 29 (74%) reported using an unblinded individual as the outcome adjudicator. Four studies (10%) reported using a second assessor to verify outcome measurements, and three studies (8%) reported the use of an adjudication committee to reach endpoint decisions via consensus. No included study provided a rationale for the use of their chosen approach to adjudication. The most commonly adjudicated outcomes included fracture healing (15 studies), reoperation rate (6 studies), and general clinical assessment of post-operative complications and limb function (30 studies), mainly by orthopaedic surgeons. Blinding of outcome assessors was not performed or unclear in 38 studies (81%).

Conclusion: Despite the importance of the outcome assessment process in orthopedic trauma trials, key aspects of outcome assessment are insufficiently reported. This limits the ability of readers to assess the validity of published trials.

Purpose: Failure to adequately recruit patients in orthopaedic trials has often led to early stopping and publication of research findings from smaller sample sizes than originally planned. The purpose of this study is to demonstrate the effect of sample size in a large, clinical trial by using SPRINT trial data to evaluate the results that would have been reported if the trial were stopped at various enrollments.

Method: The SPRINT trial evaluated reamed vs. unreamed nailing in 1226 tibia fractures. We analyzed the re-operation rates after various increments in sample size and compared the early results that would have been reported at smaller enrollments with those seen in the final, adequately powered study.

Results: In the final analysis of 1226 patients, there was a significant reduction in the risk of re-operation with reamed nails for closed fractures (35% reduction; p=0.02) and a trend towards an increased risk of re-operation for open fractures (23% increase; p=0.26). In stark contradiction, the results for the first 50 patients enrolled in the trial revealed a substantial increased risk for reamed nails in closed fractures (risk increase: 165%). It was not until enrollment reached 800 patients that the results reflected the final findings of an advantage for reamed nails. In open fractures, the trend favoring unreamed nails was not seen until 200 patients had been enrolled.

Conclusion: Our findings suggest that stopping the SPRINT trial early would have led to misleading estimates of the treatment effect between reamed and unreamed nails.

Purpose: To determine the effect of reamed versus non-reamed intramedullary (IM) nailing of femoral diaphyseal fractures on the rates of non-union and acute respiratory distress syndrome (ARDS).

Method: We searched the online databases of OVID, MEDLINE, EMBASE, PubMed, and the Cochrane collaboration for randomized clinical trials (RCT) from 1998 to 2009. Additional studies were identified by hand searches of major orthopaedic journals, reference lists of eligible studies, SCISEARCH, and title reviews of presentations from major orthopaedic trauma meetings. Inclusion criteria were trials evaluating the effect of reamed versus nonreamed closed interlocked intra-medullary nailing of femoral diaphyseal fractures on the rates of nonunion or acute respiratory distress syndrome (ARDS) in skeletally mature adults. Exclusion criteria included patients with pathologic fractures, skeletally immature patients, as well as observational and other non-randomized studies.

Results: Seventy-two citations were initially identified out of 1,147 studies. 6 studies matched all eligibility criteria as assessed by three independent reviewers. A total of 941 patients with 956 femoral diaphyseal fractures treated with intramedullary nailing met the eligibility criteria. The relative risk of non-union (four trials, n= 456 patients) was 0.29 [95% confidence interval (CI), 0.14 to 0.57; p< 0.00001] (ie. a 70% relative risk reduction of nonunion) in favour of a reamed intramedullary nail There was no significant difference in the rates of ARDS following reamed or non-reamed nailing, relative risk for ARDS (two trials, n=397) 1.10 [95% CI, 0.27 to 4.54, p=0.18].

Conclusion: The study suggests that reamed intramedullary nailing of femoral diaphyseal fractures significantly reduces the risk of non-union as compared to nonreaming. The risk of ARDS was not statistically significant between groups; however there was a slight trend towards ARDS iwith reamed IM fixation.

Purpose: Minimizing tip-apex distance (TAD) has been shown to reduce clinical failure of extramedullary sliding hip screws used to fix peritrochanteric fractures. There is debate regarding the optimal position of the lag screw in the femoral head when a cephalomedullary nail is used to treat a peritrochanteric fracture. Some authors suggest the TAD should be minimized as with an extramedullary sliding hip screw, while others suggest the lag screw should be placed inferior within the femoral head. The primary goal of this study was to determine which of 5 possible lag screw positions in the femoral head provides greatest mechanical stiffness and/or load-to-failure for an unstable peritrochanteric fracture treated with a cepha-clomedullary nail. The secondary goal was to determine if there is a linear correlation between implant-femur mechanical stiffness and/or load to failure (dependent variables) with a series of five radiographic measurements (independent variables) of distance from the lag screw tip to the femoral head apex.

Method: Long Gamma 3 Nails (Stryker, Mahwah, NJ) were inserted into 30 left synthetic femurs (Pacific Research Laboratories, Vashon, WA). An unstable four-part fracture was created, anatomically reduced, and repaired using one of 5 lag screw placements in the femoral head:

superior (n=6),

All specimens were radiographed in the anterioposterior and lateral planes, and radiographic measurements including TAD and a calcar referenced tip-apex distance (CalTAD) were calculated. All specimens were tested for axial, lateral, and torsional stiffness, and then loaded-to-failure in the axial position using an Instron 8874 (Canton, MA). ANOVA was used to compare means of the five treatment groups. Linear regression analysis was used to compare stiffness and load-to-failure (dependant variables) with radiographic measurements (independent variables). A post hoc power analysis was performed.

Results: The inferior lag screw position had significantly greater mean axial stiffness than superior (p< 0.01), anterior (p=0.02) and posterior (p=0.04) positions. Analysis revealed significantly less mean torsional stiffness for the superior lag screw position compared to other lag screw positions (p< 0.01 all 4 pairings). No statistical differences were noted for lateral stiffness. Superior and central lag screw positions had significantly greater mean load-to-failure than anterior (p< 0.01 and p=0.02) and posterior (p< 0.01 and p=0.05) positions.

There were significant negative linear correlations between stiffness tests with CalTAD, and load-to-failure with TAD. Power was greater than 95% for axial stiffness, torsional stiffness and load-to-failure tests.

Conclusion: Position of the lag screw in the femoral head affects the biomechanical properties of the implant-femur construct. Central placement of the lag screw with minimization of TAD may provide the best combination of stiffness and load-to-failure.

Purpose: Cephalomedullary nails rely on a large lag screw that provides fixation into the femoral head. There is an option to statically lock the lag screw (static mode) or to allow the lag screw to move within the nail to compress the intertrochanteric fracture (dynamic mode). The purpose of this study was to compare the biomechanical stiffness of static and dynamic modes for a cephalomedullary nail used to fix an unstable peritrochanteric fracture.

Method: Thirty intact synthetic femur specimens (Model #3406, Pacific Research Laboratories, Vashon, WA) were potted into cement blocks distally for testing on an Instron 8874 (Instron, Canton, MA). A long cephalomedullary nail (Long Gamma 3 Nail, Stryker, Mahwah, NJ) was then inserted into each of the femurs. An unstable four-part fracture was created, anatomically reduced, and the cephallomedullary nail was reinserted. Mechanical tests were conducted for axial, lateral, and torsional stiffness with the lag screws in:

static and

A paired student’s t test was used to compare the 2 modes.

Results: The axial stiffness of the cephalomedullary nail was significantly greater (p< 0.01) in the static mode (484.3±80.2N/mm) than in the dynamic mode (424.1±78.0N/mm) (Fig.2A). Similarly, the lateral bending stiffness of the nail was significantly greater (p< 0.01) in the static mode (113.9±8.4N/mm) than in the dynamic mode (109.5±8.8N/mm). The torsional stiffness of the nail was significantly greater (p=0.02) in the dynamic mode (114.5±28.2N/mm) than in the static mode (111.7±27.0N/mm).

A post hoc power analysis with & #945;=0.05 and & #946;=0.20 revealed that the paired t test on 30 samples was sufficiently powered to determine a difference in mean axial stiffness of 33.0N/mm (6.8% of static stiffness), a difference in mean lateral bending stiffness of 3.6N/mm (3.2% of static stiffness) and a difference in mean torsional stiffness of 3.4N/mm (3.0% of static stiffness).

Conclusion: Our results show that there is a 60N/mm reduction in axial stiffness of the cephalomedullary nail when the lag screw is changed from static to dynamic mode. This represents a 12.4% reduction in axial stiffness with a change from axial to dynamic modes which may be clinically significant. The differences in lateral (4.4N/mm, 3.9%) and torsional (2.8N/mm, 2.4%) are small enough that they are likely not clinically significant. We felt that a difference of greater than 10% in axial stiffness and a difference of greater than 5% in lateral or torsional stiffness would be clinically significant. Our study was adequately powered to detect these differences. Given the significant reduction in axial stiffness with dynamization of the cephalomedullary nail construct, we recommend use of the static mode when treating unstable peritrochanteric fractures with a cephalomedullary nail.

Purpose: Preoperative planning forces the surgeon to understand the “fracture personality” and devise an operative plan. In our experience, trainees have difficulty in preparing for complex acetabular cases; these fractures are among the most difficult fractures to conceptualize and teach. As a result, these fractures are poorly understood as demonstrated by low interobserver agreement between trainees in the classification of acetabular fractures. We sought to determine whether the use of visou-haptic technology would help trainees to appreciate the “personality” of an Associated-Both-Column (ABC)fracture more accurately than trainees taught by conventional instruction.

Method: Thirty senior medical students and PGY1 residents, were randomized into two groups. The control group studied an ABC fracture with the aid of a textbook excerpt and a 3D CT reconstruction of the fracture. The intervention group was given the same instructional materials, and a visuo-haptic CT model of the fracture. All other learning variables, including time on task were standardized. Participants were evaluated on their accuracy in drawing the fracture lines on a model pelvis.

Results: There was no significant difference in gender, visuo-spatial ability, and training level between groups. The participants taught with the visuo-haptic model recalled an additional 26% anatomic relationships (p< 0.01) compared with the control group.

Conclusion: These findings suggest that in addition to the benefits observed in the learning of motor skills, visuo-haptic input may improve the understanding of spatial relationships. This technology may be a useful adjunct for teaching anatomy, as well as preoperative planning.

Purpose: Accurate prediction of re-operation following tibial nailing may facilitate optimal patient care. We recently completed the SPRINT trial, a large, multi-centre trial of reamed versus non-reamed intramedullary nails in 1226 patients with tibial shaft fractures. Using the SPRINT data, we conducted an investigation of baseline and surgical patient characteristics to determine if they are associated with increased risk of re-operation within one year.

Method: Using multivariable logistic regression analysis, we investigated 15 characteristics for association with increased risk of re-operations. Because the primary SPRINT analysis found that reamed nailing reduced events in patients with closed but not open fractures, we considered both open and closed as well as treatment status in our model.

Results: We found an increased risk of re-operation in patients with a high energy mechanism of injury (odds ratio, OR=1.57, 95% CI 1.05 to 2.35), stainless steel versus titanium nail (OR=1.52, 95% CI 1.10 to 2.13), fracture gap (OR=2.40, 95% CI 1.47 to 3.94) and post-operative weightbearing (OR=1.63, 95% 1.003 to 2.64). Open fractures increased the risk of re-operation in patients who received a reamed nail (OR=3.26, 95% CI 2.01 to 5.28) but not in patients who received a non-reamed nail (OR=1.50, 95% CI 0.92 to 2.47). Patients with open fractures who had either wound management without any additional procedures, or delayed primary closure, had a decreased risk of re-operation when compared to patients who required subsequent reconstruction (respectively, OR=0.18, 95% CI 0.09 to 0.35; OR=0.29 95% CI 0.14 to 0.62).

Conclusion: To ensure optimal patient care surgeons should consider the characteristics identified in our analysis to reduce risk of re-operation.

Purpose: The use of UHMW polyethylene acetabular liners is known to cause polyethylene wear related osteolysis, the major limiting factor in its use in the younger active patient. Modern alumina ceramic articulations have been developed in order to reduce wear and avoid polyethylene debris. This prospective randomized long-term study aims to compare the outcome between an alumina ceramic-on-ceramic (CC) articulation with a ceramic on UHMW polyethylene articulation (CP).

Method: Fixty-six hips in 55 patients with mean age 42.2 (range 19–56) each received uncemented components (Wright Medical) and a 28mm alumina head with acetabular liner selected via sealed envelope randomization following anesthetic induction. Subsequent regular clinical and radiologic follow up measured patient outcome scores and noted any radiological changes.

Results: Twenty-six CP hips and 30 CC hips were evaluated. One failure required revision in each group. Mean St Michael’s outcome score for each group with up to 10 years follow-up (median 8 years, range 1–10) was 22.8 and 22.9 respectively (p=0.057). Radiographs with a minimum 5 years post-operative follow-up were analyzed in 42 hips (23 CC and 19 CP). The mean time of wear measurement for the CC group was 8.3 years (SD 1.3, Range 4.8–10.1 years) and for the CP group was 8.1 years (SD 0.9, Range 6.1–9.2 years)(p=0.471). Wear was identified in all but one CP hip but in only 12 of 23 CC replacements. Mean wear in the CP group was 0.11mm per year and 0.02mm per year in the CC group (p< 0.001).

Conclusion: To our knowledge this is the first long term randomized trial comparing in-vivo ceramic-on-ceramic with ceramic-on-polyethylene hip articulations. Other than significantly greater wear in the polyethylene group there was no significant difference in long-term outcome scores between the two groups with up to 10 years of follow-up. The use of a ceramic-on-ceramic bearing is a safe and durable option in the young patient avoiding the concerns of active metal ions and osteolytic polyethylene debris.

Purpose: Vascular Endothelial Growth Factor (VEGF) plays an important role in promoting angiogenesis and osteogenesis during fracture repair. Our previous studies have shown that cell-based VEGF gene therapy accelerates bone healing of a rabbit tibia segmental bone defect in-vivo, and increases osteoblast proliferation and mineralization in-vitro. The aim of this project was to examine the effect of exogenous human VEGF (hVEGF) on the endogenous rat VEGF messenger RNA (mRNA) expression in a cell-based gene transfer model.

Method: The osteoblasts were obtained from the rat periosteum. The fibroblasts were obtained from the rat dermal tissue. The cells were then cultured to reach 60% confluence and transfected with hVEGF using Superfect. Four groups were:

osteoblast-hVEGF,

The cultured cells were harvested at 1, 3 and 7 days after the transfection. The total mRNA was extracted (TRIZOL); both hVEGF and rat VEGF mRNA were measured by reverse transcriptase-polymerase chain reaction (RT-PCR) and quantified by VisionWorksLS.

Results: The hVEGF mRNA was detected by RT-PCR from transfected osteoblasts after three days of gene transfection. The hVEGF mRNA expression in transfected fibroblasts increased exponentially at days 1, 3 and 7 after the transfection. We compared the endogenous rat VEGF mRNA expression level of the osteoblasts or fibroblasts that were transfected with hVEGF with the cells without the transfection. The hVEGF transfected osteoblasts had a greater rat VEGF mRNA expression than the non-transfected osteoblasts. Furthermore, when hVEGF was transfected to the rat fibroblasts, the endogenous mRNA expression level measured was also greater than that from the non-transfected fibroblasts. Rat VEGF mRNA expression increased in the first three days of the hVEGF transfection, but the expression level was reduced at Day 7.

Conclusion: These results suggest that cell-based hVEGF gene therapy enhances endogenous rat VEGF mRNA expression in both osteoblasts and fibroblasts.

Purpose: The purpose of this study was to relate the extent of reaming to bone formation occurring around a critical sized defect in the tibia.

Method: Eleven canines were allocated into 2 groups: empty (N=5) or iliac crest autograft (N=6). All tibiae were reamed to 7.0 mm and fixed with a 6.5 mm statically locked intramedullary nail after creation of an 8.0 mm diaphyseal defect. The extent of reaming of the canal was dependent on the cross-sectional area of the tibia as all tibiae were reamed to 7.0 mm. Fluorescent markers were given at different times: calcein green (6 weeks), xylenol orange (9 weeks), and tetracycline (11 and 14 weeks). Animals were sacrificed at 15 weeks and perfused with a barium compound. Radiography, Micro CT, brightfield microscopy and fluorescent microscopy were used for analysis.

Results: Bone and vasculature volume within the defect were reported as a percentage of the total volume of the defect. Linear regression analysis of percent bone volume (dependent variable) and canal area (independent variable) provided a Pearson correlation coefficient of 0.925 (p=0.025) for the empty group and 0.244 (p=0.641) for the autograft group. Linear regression analysis of percent vasculature volume (dependent variable) and canal area (independent variable) provided a Pearson correlation coefficient of 0.784 (p=0.117) for the empty group and −0.146 (p=0.783) for the autograft group. Bone formation at osteotomy sites was defined as the distance from the original osteotomy site to the tip of newly formed bone. Linear regression analysis of bone formation at the osteotomy sites (dependent variable) and canal area (independent variable) provided a Pearson correlation coefficient of 0.132 (p=0.832) for the empty group and −0.937 (p=0.006) for the autograft group. Bone formation rates were reported as the distance between the fluorescent labels. Bone formation rate was less within the endosteum, cortex and periosteum with extensive reaming in empty samples.

Conclusion: Our results suggest that the acute management of tibia fractures with bone defects should involve limited reaming. This does not apply when the defect is autografted. Limited reaming may be defined by the cross-sectional area of the tibia in ratio to that of the reamer.

Purpose: To conduct a study to identify differences in complication rates and outcomes between previously recognized sub-groups commonly treated for limb length discrepancies (LLD).

Method: Forty-two males and 13 females were treated for LLD at two level-one trauma centres. Mean LLD was 4.4 cm (range 1.8 to 18cm). There were 44 femoral segments (in 41 patients) and 14 tibia segments lengthened. Forty were post-traumatic, and 18 congenital/ developmental. Objective data regarding complications, length achieved, and lengthening duration was collected from patient records. Two groups were compared for differences: Developmental (congenital and developmental etiology combined; LLD occurred prior to skeletal maturity and treatment involved creating new length) versus post-traumatic (restoration of previously existing length), and tibia versus femoral lengthening.

Results: A mean of 4.4 cm of length was achieved over a mean duration of 83 days, for a mean lengthening index of 18.9 days/cm. Superficial pin tract infections were the most common complication, occurring in 33 segments (56%). Deep infection occurred in six segments (10%). Three of these six had a history of open fracture, and a fourth had a history of infection during initial fracture management. All were successfully treated with irrigation and debridement, and exchange nailing. The developmental group had significantly greater incidence of flexion contracture (13% versus 78%, p< 0.001), and surgical correction for a contracture deformity (5% versus 61%, p< 0.001). The post-traumatic group had a significantly higher rate of painful hardware requiring removal following successful treatment of their LLD (45% versus 16%, p=0.04). Tibia segments had a significantly greater lengthening index (29 d/cm versus 18 d/cm, p=0.03).

Conclusion: Limb lengthening is an involved process with potential for serious complications. Patients who had limb-lengthening for congenital/ developmental discrepancies had a higher rate of adjacent joint contrac-ture and subsequent requirement for surgical release. Patients with post-traumatic lengthening had a higher rate of hardware removal, and the lengthening index was greater for tibiae than femora. Deep infection remains a significant concern. This study provides information for physicians and patients on the rate and type of complications that can be expected both overall, and within specific LLD treatment groups.

Purpose: While the durability of most uncemented femoral stems remains unknown, it is the aim of this study to demonstrate Echelon Primary femoral stem performance with regard patient outcome and overall implant survival.

Method: Between February 1998 and March 2007, 428 patients received the Echelon Primary stem. The mean age of each patient was 58.1 (SD 11.1, Range 20–87). Body mass index averaged 30.5 kg/m2 (SD 5.8, Range 17.7–58.2). The majority of patients received a Reflection uncemented acetabular component (91%) and an ultra high molecular weight polyethylene liner (76.5%), although the highly cross linked polyethylene is now used with increased frequency, used in 31% of hips since 2005. The majority of femoral heads were cobalt chrome (79.3%).

Results: Kaplan Meier survivorship for the Echelon Femoral stem with revision for aseptic loosening as end point at 100 months is 99.3% (95% CI 97.1–99.8). Taking revision for any reason as the end point the Kaplan Meier survivorship is 98.3% at 100 months (95% CI 95.9–99.3). A pre-operative WOMAC score was available for 345 of the 392 patients with mean score of 43.5 (95% CI 41.6–45.4). At the three-month post-operative review the mean WOMAC score was significantly increased to 74.54 (95% CI 72.7–76.3)(p< 0.001) and by 1 year 84.3 (95% CI 80.5–88.1). At subsequent years, the modified WOMAC score remained at a plateau of around 80. General health assessment using the SF-36 shows an improvement in the physical component score from 33.1 (95% CI 32.3–33.9) preoperatively to 42.6 (95% CI 41.7–43.6)(p< 0.001) at three months and 48.19 (95% CI 44.2–52.2) at latest follow up. The mental component scores increased from 48.7 (95% CI 47.6–49.9) to 51.4 (95% CI 50.3–52.4)(p< 0.001) and 53.5 (95% CI 50.3–56.6) respectively.

Conclusion: This large prospective review of the Echelon Primary femoral stems reveals an excellent survivorship of the stem with a 99.3% survival at 8 years with regard aseptic loosening and 98.3% survival including revision for any reason. Patient outcome scores are significantly improved and subsequently maintained. There have been no changes with regard to manufacture or design of the stem within the period of review.

Purpose: Endothelial Progenitor Cells (EPCs) have been proven to contribute to formation of new blood vessels. The objective of this study was to evaluate the effects of local EPC therapy on the stimulation of angiogenesis at a fracture site and the promotion of bone healing by increasing osteogenesis and callus formation.

Method: Rat bone marrow EPCs were isolated and cultured. A segmental bone defect (4mm.) was created in the rat femur diaphysis and stabilized with a mini-plate. A gelfoam piece impregnated with a solution of EPCs (1x106) was placed into the fracture gap. Control animals received only saline-gelfoam with no cells. In total, 42 rats were studied: 21 in EPC and 21 in control groups. Seven animals were sacrificed from each group at one, two, and three weeks post-operatively. Plain radiographs of the operated femur were taken before sacrifice. Operated femurs were harvested and the specimens from the osteotomy site were collected for histological evaluation. The x-rays were scored in a scale from zero to five according to the percentage and the intensity of the bone filling at the osteotomy site. Hematoxylin-eosin stained slides were evaluated for new vessel formation and the amount of bone tissue.

Results: Radiographically, at three weeks, the mean score for the EPC group was 4.5 with five out of seven animals having bridging callus; whereas for the control group, the mean score was 2.2 with no bridging callus formation. At two weeks, EPC treated animals had a mean score of 2.4, and the control group had a score of 1. Bone formation was insignificant at one week in either group, however, the scores tended to be higher in the EPC group animals than the control; 0.6 to 0.3 respectively. Histological evaluation revealed that the specimens from EPC treated animals had abundant spicules of trabecular bone containing predominantly bone cells, osteoid, and new vessels. Conversely, control animals had scarce trabecular bone with markedly less bone cells and vessels.

Conclusion: Local EPC therapy stimulates angiogenesis and increases osteogenesis and callus formation post fracture. Our report encourages further investigation of the local use of EPCs as a potential therapy to promote bone regeneration.

Purpose: Identifying optimal treatment strategies in patients with traumatic foot and ankle injuries has been hampered by the variety of different measurement tools and lack of validation of generic and foot-specific functional measures. It remains plausible that the choice of functional outcome measure may influence our ability to accurately measure treatment effects. This prospective observational study aims to correlate the scores across six functional outcome measures in patients with traumatic foot and ankle injuries and to examine agreement of scores and patients’ subjective health status.

Method: Patients with traumatic foot or ankle injuries completed two generic, the SF-12 Health Survey and the Short Musculoskeletal Functional Assessment (SMFA), and four specific health outcome measures, the Foot Function Index (FFI), Foot and Ankle Ability Measure (FAAM), American Academy of Orthopedic Surgeons (AAOS) Foot and Ankle Questionnaire and the American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale, at a single follow-up visit. Raw scores were calculated and used to assign patients to a categorical functional level (excellent, very good, good, fair or poor). Agreement between the assignments was assessed and Pearson correlation co-efficients were calculated for each pair of outcome scores. Statistical significance was determined using an α of 0.05.

Results: 52 patients (mean age 43.3 ± 16.8 years) were enrolled at a mean follow-up of 15.5 months. All correlations except for that between the AOFAS ankle-hindfoot scale and the mental component of the SF-12 were statistically significant. The strongest correlations were found between the SMFA, FFI, AAOS Foot and Ankle Questionnaire and the FAAM. Despite significant correlation between scores and patients’ subjective functional outcome, there was minimal agreement between assigned categorical functional levels.

Conclusion: The high correlations between scores on the generic and foot-specific functional measures suggest that it is likely unnecessary to use more than one instrument when examining functional outcome in patients with traumatic foot and ankle injuries. Generic tools also appear to function as well as specific scores in this population. However, assignment of patients to a categorical functional level based on raw outcome scores must be performed with caution as the results obtained may not accurately reflect functional outcome.

Purpose: Hip resurfacing is a technically demanding alternative to total hip arthroplasty. Placement of the initial femoral guidewire utilizing traditional mechanical jigs may lead to preparatory errors and a high degree of variability in final implant stem-shaft angle (SSA). Intraoperative computer navigation has the potential to decrease preparatory errors and provide a reliable method of femoral component placement. The current study evaluated the accuracy and learning curve of 140 consecutive navigated hip resurfacing arthroplasties.

Method: Between October 2005 and May 2007, 140 consecutive Birmingham Hip Resurfacings were performed on 132 patients (107 male, 25 female). The mean age of the cohort was 51.2 years (range 25–82). Indications for surgery included osteoarthritis (n=136) and avascular necrosis (n=4). Preoperative templating was performed using digital AP unilateral hip radiographs. Neck-shaft angles (NSA) were digitally measured and relative implant stem-shaft angles planned. The central guidewire was drilled and verified intra-operatively using an imageless navigation system. Implant stem-shaft angles were assessed using 3 month post-operative radiographs.

Results: Pre-operative templating determined a mean NSA of 132.2 degrees (SD 5.3 degrees, range 115–160). The planned SSA was a relative valgus alignment of 9.5 degrees (SD 2.6 degrees). The post-operative SSA differed from the planned SSA by 2.5 degrees (SD 1.9 degrees, range 0–8). The final SSA measured within ±5 degrees of the planned SSA in 89% of cases. Of the remaining 11% of cases, all measurements erred in valgus. No cases of neck notching or varus implant alignment occurred in the series. The mean navigation time for the entire series was 18 minutes (SD 6.6 minutes, range 10–50). A learning curve was observed with respect to navigation time, with a significant decrease in navigation time between the first 20 cases and the remainder of the series. There was no evidence of a learning curve for implant placement accuracy.

Conclusion: Imageless computer navigation shows promise in optimizing preparation of the femoral head and reducing the introduction of mechanical preparatory factors that predispose to femoral neck fracture. Navigation may afford the surgeon an accurate and reliable method of femoral component placement with negligible learning curve.

Purpose: The aim of our study was to evaluate bone formation and angiogenesis produced within a biodegradable poly-D, L-lactide-co-glycolide acid/calcium phosphate (PLGA/CaP) scaffold when used to treat a diaphyseal tibia defect and compare this to an iliac crest autograft or an empty defect.

Method: An 8.0 mm diaphyseal defect was created in a canine tibia model. All tibiae were reamed to 7.0 mm and fixed with a 6.5 mm statically locked intramedullary nail. Eighteen canines were allotted into three treatment groups:

empty (N=5),

Fluorescent markers were given at different times: calcein green (six weeks), xylenol orange (nine weeks), and tetracycline (11 and 14 weeks). Animals were sacrificed at 15 weeks and perfused with a barium compound. Radiography, Micro CT, and brightfield and fluorescent microscopy were used for analysis.

Results: Micro CT and brightfield images of scaffold samples displayed multiple vessels (10 to 100μm) within the scaffold. The bone volume and vasculature volume (measured with Micro CT) within the tibial defect site were reported as a percentage of the total volume of the defect site. The percent bone volume within the defect site was not different between treatment groups (p=0.112). There was greater percent vasculature volume in the scaffold group than the autograft group (p< 0.001). Bone formation at the osteotomy sites was defined as the distance from the original osteotomy site to the tip of newly formed bone. Osteotomy bone formation was significantly greater in the scaffold group than the autograft group (p=0.015). Osteotomy sites associated with greater angiogenesis displayed greater bone formation. Bone formation rates were reported as the distance between the fluorescent bone labels. Autograft samples had the greatest bone formation rates within the periosteum. Autograft and scaffold samples had the greatest rate of bone formation within the cortex.

Conclusion: Our canine tibial defect model provides a satisfactory facsimile of the traumatic tibia fracture with associated bone loss. The PLGA/CaP biodegradable scaffold we have employed promotes angiogenesis within a defect and could be used in conjunction with autografting.

We conducted a systematic review and meta-analysis of randomised controlled trials comparing cross-linked with conventional polyethylene liners for total hip replacement in order to determine whether these liners reduce rates of wear, radiological evidence of osteolysis and the need for revision. The MEDLINE, EMBASE and COCHRANE databases were searched from their inception to May 2010 for all trials involving the use of cross-linked polyethylene in total hip replacement. Eligibility for inclusion in the review included the random allocation of treatments, the use of cross-linked and conventional polyethylene, and radiological wear as an outcome measure. The pooled mean differences were calculated for bedding-in, linear wear rate, three-dimensional linear wear rate, volumetric wear rate and total linear wear. Pooled risk ratios were calculated for radiological osteolysis and revision hip replacement. A search of the literature identified 194 potential studies, of which 12 met the inclusion criteria. All reported a significant reduction in radiological wear for cross-linked polyethylene.

The pooled mean differences for linear rate of wear, three-dimensional linear rate of wear, volumetric wear rate and total linear wear were all significantly reduced for cross-linked polyethylene. The risk ratio for radiological osteolysis was 0.40 (95% confidence interval 0.27 to 0.58; I² = 0%), favouring cross-linked polyethylene. The follow-up was not long enough to show a difference in the need for revision surgery.

We systematically reviewed the peer-reviewed literature to relate the survival of hybrid metal-on-metal hip resurfacing arthroplasty devices to a National Institute of Clinical Excellence (NICE) benchmark for choosing a primary total hip replacement, which is a survival rate of 90% at a follow-up of ten years.

A total of 29 articles (10 621 resurfaced hips) met the inclusion criteria. The mean follow-up ranged from 0.6 to 10.5 years and the survival of the implant ranged from 84% to 100%. Of the 10 621 hips, 370 were revised (3.5%), with aseptic loosening as the most frequent mode of failure.

None of the hip resurfacing arthroplasty implants used to date met the full ten-year NICE benchmark of survival. A total of 13 studies showed satisfactory survival compared with the three-year NICE benchmark.

Purpose: Micro-CT is efficient, non-destructive, and accurate for qualitative and quantitative studies of bone microarchitecture during fracture healing. A cell-based vascular endothelial growth factor (VEGF) gene delivery system can increase fracture healing. Three dimensional structural variation of new bone formation in rabbit fracture segmental defects was studied with micro-CT to determine how VEGF affects these microarchitectural differences for bone healing in various periods.

Method: All animal procedures were approved by the Animal Care Committee at St. Michael’s hospital. Ten millimeter segmental bone defects were treated by local injection with cell-based VEGF gene transfer (n=15), or control group with fibroblasts alone or saline only (n=15), to stimulate differences in bone healing. The animals were sacrificed and fracture healing specimens collected at 4, 8 and 12 weeks post surgery. The region of interest (ROI) was set where the segmental defect was located, and was selected for analysis from the recognizable margins of the original defect. To describe the topographic pattern of bone healing, the ROI was divided into three areas of equal volume: proximal, middle and distal. The new bone formation and mineralization at the defect sites were evaluated by bone structural parameters from the 3-D reconstruction of micro-CT.

Results: Macroscopic evaluation of the interfragmentary section from reconstructed micro CT scans, in the VEGF treated rabbits, showed abundant fragmentary bone filling the gap of the osteotomy at 4 weeks and abundant callus bridging the gap at 8 and 12 weeks. In the control group, only small amounts of sparsely formed bone were seen in the gap at 4 weeks. In the control group, the regenerate bone was ovoid around the bone sites and a big gap remained in the segmental bone defects at 8 and 12 weeks. The bone healing micro-structural differences between the two groups varied with the period of treatment, with more differences seen at 4 than 8 or 12 weeks.

Conclusion: Cell-based VEGF gene therapy enhances fracture healing of segmental defects, and this effect is best seen in the early period following defect creation.

Purpose: The mechanical behavior of human scapholunate ligaments is not described well in the literature regarding torsion. Presently, intact scapholunate specimens were mechanically tested in torsion to determine if any tensile forces were generated as a result.

Method: Scapholunate specimens (n=19) were harvested and inspected visually. Scaphoid and lunate bones were potted in square chambers using epoxy cement. The interposing ligaments remained exposed. Specimens were mounted in a specially designed test jig and remained at a fixed axial length during testing. Using angular displacement control, ligaments were subjected to a torsional motion regime that included cyclic preconditioning (25 cycles, 1 Hz, triangular wave, 5 deg max), ramp-up to 15 deg at 180 deg/min, stress relaxation for 120 sec duration, ramp-down to 0 angulation at 180 deg/min, rest period for 5–10 minutes, and torsion-to-failure at 180 deg/min. Torque and axial tension were monitored simultaneously.

Results: Tests showed a coupled linear relationship between applied torsion and the resultant tensile forces generated for the ligament during ramp-up (Torsion/Tension Ratio = 38.86 +/− 29.00 mm, Linearity Coefficient R-squared = 0.89 +/− 0.15, n=19), stress relaxation (Ratio = 23.43 +/− 15.84 mm, R-squared = 0.90 +/− 0.09, n=16), and failure tests (Ratio = 38.81 +/− 26.39 mm, R-squared = 0.77 +/− 0.20, n=16). No statistically significant differences were detected between the Torsion/Tension ratios (p=0.13) or between the linearity (R-squared) of the best-fit lines (p> 0.085).

Conclusion: A strong linear relationship between applied torsion and resulting tensile forces for the ligament was exhibited during all testing phases. This may suggest that there is interplay between torsion and tension in both the stabilization of the scapholunate ligament during normal physiological motion and during resistance to injury processes. This is the first report in the literature of the coupling of torsion with tension for the scapholunate ligament.

Purpose: Tibial shaft fractures are a common injury. Tibial nailing is the current standard of care for these injuries, yet there is little information regarding patient based outcomes after nailing. We sought to determine the 1 year patient based outcomes and return to activities for patients with tibia fractures in a randomized trial of reamed and unreamed nail insertion.

Method: Over a 5 year period 1226 patients with 842 closed and 406 open tibial shaft fractures were enrolled in a randomized trial comparing reamed with unreamed tibial nail insertion in 29 trauma centers and had one year follow-up. The average age was 39±16 years and 74% were male. Patient based outcomes were determined using the validated Short Form-36 (SF-36) Physical Component Summary, the Short Musculoskeletal Functional Assessment (SMFA) Dysfunction Index, and a published return to activity questionnaire. Questionnaires were administered during the initial hospitalization to obtain pre-injury status, and then the same outcome instruments were used at the 2 week, 3 month, 6 month, and one year follow-up. Statistical analysis was performed comparing the groups with p < 0.05 designated as significant.

Results: There was no difference in any outcome parameter for any time frame between the reamed and unreamed groups. The 1 year SF-36 PCS (a 100 point scale with a mean of 50 in the general population, higher better) was 42.9±11 for the reamed group and 43.5±11 for unreamed group as compared with 52.5±9 for the reamed group and 53.1±9 for the unreamed group pre-injury. The SMFA Dysfunction Index (100 point scale, higher is worse) at 1 year was 18.2±17 for the reamed group and 17.5±17 for the unreamed group as compared with 7.9±13 for the reamed group and 7.7±13 unreamed group pre-injury.

Conclusion: In patients with tibial shaft fractures treated with intramedullary nails, patient based outcomes are not related to reamed or unreamed insertion. Patients sustaining tibial shaft injuries do not return to their pre-injury status based on validated outcomes assessments or return to activity by one year after injury.

Purpose: In a prospective randomized clinical trial, we have previously reported the “limb-specific” results comparing operative (plate fixation) versus non-operative (sling) treatment for completely displaced fractures of the shaft of the clavicle. We also sought to determine the effect that a fracture of the shaft of the clavicle had on general health status, as measured by the SF-36 General Health Status instrument. We then evaluated the effects of different treatment methods (operative versus non-operative), on general health scores.

Method: We performed a multi-center, randomized clinical trial of operative versus non-operative treatment of completely displaced clavicular shaft fractures in 111 patients. In addition to radiographic, surgeon-based, and limb-specific data we prospectively gathered SF-36 questionnaires at baseline, and at 6 weeks and 3, 6, 12, and 24 months post-injury.

Results: Results: Both groups had SF-36 scores equivalent to or slightly superior to population norms at baseline. A clavicular shaft fracture had a significant negative effect on SF-36 scores (especially the physical components) in both groups at 6 weeks (p< 0.01) and 3 months (p< 0.01). There was a statistically greater decrease in Physical Component Scores (PCS) in the non-operative group compared to the operative group (P< 0.05). At 6 months, scores had returned to pre-operative levels in the operative group, but remained significantly decreased in the non-operative group (p=0.04). This difference persisted at the one and two year points.

Conclusion: A displaced fracture of the clavicular shaft has a clinically significant negative effect on general health status scores. This effect can be mitigated by primary operative fixation, which restores scores to normal levels by six months post-injury. Patients treated non-operatively for a displaced fracture of the shaft of the clavicle demonstrated lower PCS scores at two years post-injury. This information is useful in counseling patients with regards to treatment options following displaced fractures of the clavicle shaft.

Purpose: The choice of irrigating fluid and delivery pressure remains controversial. Identifying surgeons’ preferences in techniques and the rationale for their choices may aid in focusing educational activities to the orthopaedic community as well as planning future clinical trials. Our objective was to clarify current opinion with regard to the irrigation of open fracture wounds.

Method: We mailed and delivered a cross-sectional survey using a sample-to-redundancy strategy to members of the Canadian Orthopaedic Association and attendees of an international fracture course (AO, Davos, Switzerland) to examine surgeons’ preferences in the initial management of open fracture wounds.

Results: Of the 1,764 surgeons who received the questionnaire, 984 (55.8%) responded. In the management of open wounds, most surgeons surveyed, 676 (70.5%), favoured normal saline alone, however 16.8% used Bacitracin. Many surgeons, 695 (71%) used low pressures when delivering the irrigating solution to the wound, however variation exists in what constituted high versus low pressure lavage. Surgeons supported the need for a clinical trial evaluating outcomes following both the use of different irrigating solutions as well as irrigating pressures [803 (84.8%) and 730 (77.6%) respectively].

Conclusion: The majority of surgeons favour both normal saline and low pressure lavage for the initial management of open fracture wounds.

Purpose: We conducted the first, multicentre, prospective cohort study to define the incidence of symptomatic venous thromboembolism (VTE) in patients with tibia and ankle fractures treated conservatively and relatively minor lower leg fractures. The reported incidence of deep vein thrombosis (DVT) using routine venography in patients with lower leg injury requiring cast immobilization is approximately 20–40%, which has lead to the routine use of anticoagulant prophylaxis for several weeks in many such patients. However the vast majority of venographically-detected DVTs are asymptomatic, distal thrombi whose clinical relevance is uncertain. Therefore venography is not the best outcome measure to assess the burden of clinically important VTE.

Method: Consecutive patients with tibia and fibula fractures (treated non-operatively) and patella and foot fractures, (treated operatively or conservatively) were assessed for eligibility at 5 Ontario hospitals. Patients were enrolled after informed consent within 96 hours of injury and were followed prospectively, by telephone, at 2, 6 and 12 weeks. Those with major trauma, active cancer, and previous VTE were excluded. Thromboprophylaxis was not allowed. Education regarding symptoms of VTE was provided at study entry and patients were asked about VTE symptoms at follow up. Suspected VTE was investigated in a standardized manner.

Results: From August 2002 to June 2005, 1200 patients were enrolled from 2446 consecutively screened patients. 98% of patients completed 3-month follow-up. The mean age was 45 years (16 to 93) and 60% were female. The most common fractures were fibular (39%) and most injuries were caused by falls (75%). 99 % of these fractures were unilateral. Most fractures did not require surgical repair (93%), and 82% of patients were immobilized by cast or splint for an average of 42 ±32 days. Overall, 7 patients had symptomatic, objectively confirmed VTE (2 proximal DVT, 3 calf DVT, 2 PE) with no fatal PE – an incidence of 0.6 % (95% CI 0.2 to 1.2).

Conclusion: Symptomatic VTE is an infrequent complication after these fractures without thromboprophylaxis. Therefore routine thromboprophylaxis is neither warranted, nor likely to be cost-effective in these patients. This study also highlights the significant discrepancy between clinical endpoint studies and studies using venography.

Purpose: Vascular Endothelial Growth Factor (VEGF) is vital for both angiogenesis and osteogenesis. The aim of this study was to investigate the effect of cell based VEGF gene delivery on the proliferation and mineralization of rabbit osteoblasts in vitro.

Method: Primary cultured rabbit osteoblasts were divided into four groups (each n=6). In Group I, osteoblasts were transfected with pcDNA3.1-VEGF; in Group II, osteoblasts were transfected with pcDNA-Efficiency Green Fluorescent Protein (EGFP); in Group III, osteoblasts were treated with the supernatant of fibroblasts that were transfected with VEGF genes; and in Group IV, osteoblasts were treated with the supernatant of fibroblasts that were transfected with EGFP. The cells were cultured in a-EME with 10% FBS, 2% penicillin/streptomycin with or without 10-^7 M dexamethasone and 50μg/ml L-ascorbic acid for 28 days. In the last 4 days, the cells were stimulated to initiate calcium mineralized nodule formation by adding 10 mM B-glycerophosphate. They were stained by the Von Kossa technique so that the number and the area of the nodules could be assessed by an imaging analysis system.

Results: The cells transfected by VEGF were indicated by the EGFP marked cells under a fluorescent microscope. There was a significant difference in the total nodule area (mean 18.38 mm² SE 3.73 and 5.07 mm² SE 0.55, p< 0.05) and count (mean 18.67 SE 3.22 and 2.17 SE 0.40, p< 0.001) between Group I and Group II (ANOVA, SPSS). More unmineralized and smaller nodules were found in Group III and Group IV. However, the nodules in Group III covered greater areas with dark brown staining in the cell culture dishes when compared with Group IV.

Conclusion: The observations indicate that cell based VEGF gene delivery has a positive effect on the proliferation and mineralization of osteoblasts. The greatest effect is seen with direct transfection of osteoblast cells. Cell-based VEGF gene therapy may be used to promote fracture healing.

The computed neck-shaft angle and the size of the femoral component were recorded in 100 consecutive hip resurfacings using imageless computer-navigation and compared with the angle measured before operation and with actual component implanted. The reliability of the registration was further analysed using ten cadaver femora. The mean absolute difference between the measured and navigated neck-shaft angle was 16.3° (0° to 52°). Navigation underestimated the measured neck-shaft angle in 38 patients and the correct implant size in 11. Registration of the cadaver femora tended to overestimate the correct implant size and provided a low level of repeatability in computing the neck-shaft angle.

Prudent pre-operative planning is advisable for use in conjunction with imageless navigation since misleading information may be registered intraoperatively, which could lead to inappropriate sizing and positioning of the femoral component in hip resurfacing.

Femur fractures are a complication of hip arthroplasty. When the stem is well fixed, fracture fixation is the preferred treatment option. Numerous fixation methods have been advocated, using plates and/or allograft struts. The study was conducted to determine the biomechanical characteristics of three constructs currently used for fixation of these fractures.

Vancouver type B1 periprosthetic femur fractures were created distal to a cemented hip stem implanted in third generation composite femurs. The fractures were fixed with one of three constructs: 1- A non-locking plate and allograft strut (NLP-A) 2- A locking plate and allograft strut (LP-A) 3- A locking plate alone. (LP) The struts were held in place with cables. There were five specimens in each group. Following fixation, the constructs underwent sinusoidal cyclic loading from 200 to 1200 N for 100000 cycles. Stiffness of the constructs was determined in bending, torsion and axial compression before and after cyclic loading. Axial load to failure was also determined.

Overall, cyclic loading had little effect on the mechanical properties of these constructs. The two constructs with allografts were significantly stiffer in coronal plane bending than the construct consisting of only a locking plate. There were no significant differences in axial or torsional stiffness between the constructs. Load to failure of the NLP-A (4095 N) and LP-A (4007 N) constructs was significantly greater than the LP construct (3398 N) (p=0.023 and p=0.044 respectively).

All three constructs tested retained their mechanical characteristics following 100000 cycles of loading. Our initial concerns that the cables holding the allograft strut would loosen appear unfounded. Allograft strut-plate constructs are stiffer in bending and have a higher load to failure than a stand-alone locking plate. When an allograft plate construct is chosen, locking screws provide no mechanical advantage in this experimental model.

Early fracture stabilization has been shown to reduce morbidity and mortality in the patient who is multiply injured. Controversy exists in terms of managing multiple trauma patients who sustain thoracic injuries along with femoral shaft fractures. The purpose of the present study was to determine whether the presence and treatment of femoral shaft fractures increases morbidity in patients with pulmonary contusions and to determine the effect of patient and surgical factors on outcome.

Patients that suffered chest injuries between January 1987 and April 2006 were identified from the prospectively collected trauma databases at two hospitals. Patient records were reviewed to verify all data. The diagnosis of pulmonary contusion was confirmed with radiologic or post-mortem investigations. All relevant patient and surgical data was collected. Exclusion criteria included severely injured patients (head/abdomen AIS> 3), age sixty years, death twenty-four hours after injuries occurred.

A total of 1190 patients with confirmed pulmonary contusions met inclusion criteria; there were 113 femoral shaft fractures (five bilateral). Patients in both the isolated pulmonary contusion and pulmonary contusion with femoral fracture had similar injury severity scores (ISS) and demographic information. Fractures were reduced with intramedullary nailing in 88% of cases. Mean age was thirty-five years. There were significantly more incidences of fat embolism syndrome and acute lung injury (ALI) in patients with femoral factures (twenty-four hours following the injury had significantly greater risk of developing ARDS (p< 0.05).

The presence of femoral shaft fractures in patients with pulmonary contusions increases the duration of admittance to hospital and can lead to higher rates of fat embolism syndrome and ALI, however it does not appear to impact overall mortality or contribute to the development of other common respiratory complications. Early reduction of shaft fractures is encouraged to further decrease complications.

Fat embolism syndrome (FES) is a potentially lethal condition commonly seen in poly-traumatised patients, particularly those with multiple long-bone fractures. Treatment has centered around supportive care and early fracture fixation. Several clinical small trials have suggested corticosteroids benefit patients with FES but its use remains controversial. Our objective was to determine the effect of corticosteroids in preventing FES in patients with multiple long-bone fractures.

We conducted a meta-analysis of randomised trials, searching computerised databases for published studies from 1966–2006. Additionally, we performed hand searches of major orthopaedic journals, meeting proceedings, and texts. Our primary outcome was the rate of FES. Secondary outcomes included presence of hypoxia, petechiae, mortality, infection, and delayed union.

Of the one hundred and four studies identified, nine were potentially eligible, and only seven met all our eligibility criteria. From our pooled analysis of three hundred and eighty-nine patients, we found that corticosteroids reduced the risk of FES by 78% (95%CI: 43–92%, heterogeneity p-value=0.62, I2=10%) and that only eight patients needed to be treated (NNT=7.5) to prevent one case of FES (95%CI: five to thirteen patients). We did not find any significant differences in the rates of mortality, infection, or delayed union.

The current evidence suggests that the use of corticosteroids is beneficial in the prevention of fat embolism syndrome in patients with multiple long-bone fractures. The use of corticosteroids does not appear to significantly increase the risk of complications although a confirmatory large randomised trial is needed.

We sought to establish whether fibroblasts transfected ex vivo could be delivered via gelfoam impregnated with a solution of transfected cells to achieve local transgene expression in a fracture site.

A 10 millimeter segmental bone defect was created after 12 mm periosteal excision and plated in the middle one third of each rabbit tibia. Dermal tissues were obtained and fibroblasts were cultured with DMEM. Fibroblasts were labeled with CMTMR and 5x106 labeled fibroblasts in 1ml PBS with 1x1 cm? Impregnated gelfoam was placed into the fracture gap (n=2). Twenty four hours after cell injection, the rabbits were killed and specimens were harvested from the fractured leg. Using SuperFect (Qiagen Inc), the primary fibroblasts were transfected with pcDNA-VEGF which was generated with the full length coding sequence of the human VEGF gene. A convenient reporter gene, Efficiency Green Fluorescent Protein (EGFP), was used for monitoring transfection of VEGF by fluorescence intensity. Experimental rabbits received 5.0 X 106 VEGF transfected cells in 1 ml PBS via gelfoam at the fracture sites. The animals were sacrificed at seven days (n=4), fourteen days (n=4) and twenty-one days (n=4) post surgery and the fracture site specimens were collected for analysis.

The fluorescently labeled cells with CMTMR were found at the fracture site and surrounding tissues. It was demonstrated that the labeled cells were delivered into the fracture gap, bone marrow and muscle surrounding a segmental defect in the rabbit. In the VEGF group, visualised VEGF immunostaining (brown) was shown in the fracture site around the Gelfoam; as well VEGF was distributed at sites of endochondral ossification. Visible bone formation was shown: VEGF promoted new bone formation by VonKossa staining (dark) and produced numerous vessels by CD31 positive staining (brownish black). The VEGF protein was detected in and around the fracture by ELISA.

This data encourages the further development of genetic approaches using cell based VEGF gene transfer without viral vectors to promote fracture healing.

Gaining stable fixation in cases of recalcitrant non-unions can be challenging. These cases can be accompanied by a segmental bone defect and disuse osteopenia. One strategy to gain stable fixation is the use of allografts. Both cortical struts and intramedullary fibular allografts have been used for this purpose in the femur, tibia and humerus. The present study aims to compare the mechanical properties a locking plate, an intramedullary fibular strut allograft and a cortical strut allograft in a femur model of segmental bone defect.

A transverse mid-shaft osteotomy was performed in fifteen third generation large composite femurs. Twelve millimeters of bone was resected to create a segmental bone defect. Fixation was undertaken as follows: Construct F (Fibula): Lateral Non Locking plate and Intramedullary Fibula Allograft Construct LP (Locking Plate): Lateral Locking Plate Constrcut S (Strut): Lateral Non-Locking Plate and Medial Cortical Strut Allograft Axial, Torsional and Bending Stiffness as well as Load-to-Failure were determined using an Instron 8874 materials testing machine.

Overall, construct S was the stiffest, construct F intermediate and construct LP the least stiff. Specifically, the S construct was significantly (p< 0.05) stiffer than the two other constructs in the axial, coronal plane bending, sagital plane bending and torsional modes. Construct F was significantly stiffer than construct LP in the axial and coronal plane bending modes only. Both the S construct (6108 N) and the F construct (5344 N) had a greater Load-to-Failure than the LP construct (2855 N) (p=0.005 and 0.001 respectively).

The construct with a lateral non-locking plate and a medial allograft strut was stiffer and had a higher load-to-failure than the construct consisting of a stand-alone locking plate. An intramedullary fibular allograft with a lateral non-locking plate had intermediate characteristics. Other factors, such as anatomic and biologic considerations need to be considered before choosing one of the above constructs. The allograft procedures should only be used once soft tissue coverage has been obtained and any infection eradicated.

We have investigated the accuracy of placement of the femoral component using imageless navigation in 100 consecutive Birmingham Hip Resurfacings. Pre-operative templating determined the native neck-shaft angle and planned stem-shaft angle of the implant. The latter were verified post-operatively using digital anteroposterior unilateral radiographs of the hip.

The mean neck-shaft angle determined before operation was 132.7° (118° to 160°). The mean planned stem-shaft angle was a relative valgus alignment of 9.7° (sd 2.6). The stem-shaft angle after operation differed from that planned by a mean of 2.8° (sd 2.0) and in 86% of cases the final angle measured within ± 5° of that planned. We had no instances of notching of the neck or varus alignment of the implant in our series. A learning curve was observed in the time taken for navigation, but not for accurate placement of the implant.

Navigation in hip resurfacing may afford the surgeon a reliable and accurate method of placement of the femoral component.

A total of 20 pairs of fresh-frozen cadaver femurs were assigned to four alignment groups consisting of relative varus (10° and 20°) and relative valgus (10° and 20°), 75 composite femurs of two neck geometries were also used. In both the cadaver and the composite femurs, placing the component in 20° of valgus resulted in a significant increase in load to failure. Placing the component in 10° of valgus had no appreciable effect on increasing the load to failure except in the composite femurs with varus native femoral necks. Specimens in 10° of varus were significantly weaker than the neutrally-aligned specimens.

The results suggest that retention of the intact proximal femoral strength occurs at an implant angulation of ≥ 142°. However, the benefit of extreme valgus alignment may be outweighed in clinical practice by the risk of superior femoral neck notching, which was avoided in this study.

Thirty total hip replacements in twenty-eight patients in which a Zirconia/Polyethylene articulation was utilized were compared to a control group undergoing total hip replacement utilizing Cobalt-Chrome/Polyethylene articulation. These patients were matched for gender, BMI and pre-operative diagnosis.

At nine years after implantation there was no difference in the functional outcome between the two groups and no difference in liner wear rate on x-ray (Livermore technique). There was a 27% revision rate in the Zirconia group compared to the 11.5% revision rate in the Cobalt-Chrome group.

Bearing surfaces require long- term clinical follow-up to validate in vitro performance.

To determine the benefit of Zirconia on polyethylene versus cobalt-chrome on polyethylene in total hip articulation.

Zirconia offers no advantage over a cobalt-chrome head in decreasing in vivo polyethylene wear at ten- year follow-up.

Newer bearing surfaces require long- term clinical follow-up to validate in vitro laboratory performance.

All primary total hip replacements at this institution are entered prospectively in a database and are assessed on an annual basis. All patients in this study were followed for a mean of nine years with a range of six to thirteen years.

Thirty cementless total hip arthroplasties were performed in twenty-eight patients utilizing a Zirconia head coupled with a polyethylene acetabular component. Twenty-six hips have been followed for a mean of nine years. These were matched to a control group of twenty-six hips in twenty-six patients utilizing a cobalt-chrome head coupled with an identical polyethylene liner followed for a mean of ten years (range five to fourteen years). There was no functional difference in outcome at nine years between the two groups utilizing the Livermore technique there was no difference in the liner wear rate between the two patient groups. However, seven hips (27%) of the Zirconia group required revision due to loosening and/or extensive osteolysis around the cup and only three hips (11.5%) required revision in the cobalt-chrome group. Our study demonstrates that although changes in component designs and materials may offer theoretical advantages over current components their effect in vivo remains questionable.

This study (n=126, mean age=68.8 years, males=62) evaluated pre-operative WOMAC pain and physical function, age, gender, general health status, revision severity classification, number of revisions, comorbidity and unilateral vs. bilateral surgery as predictors of WOMAC pain and physical function at twenty-four months post revision hip arthroplasty. Pain improved from 9.3 to 3.6 and physical function improved from 35.4 to 17.1. No factors were predictive of patient function. Decreased pain was predicted by less pain pre surgery (p=0.01) and being male (p=0.04).

To determine if pre-operative WOMAC pain and physical function, age, gender, general health status (SF-36), revision severity classification, number of revisions, comorbidity and unilateral vs. bilateral surgery are predictive of WOMAC pain and physical function at twenty-four months post revision hip arthroplasty.

Physical function at twenty-four months is not independently predicted by the pre-treatment factors evaluated in this study. Male patients with less pain pre surgery and little comorbidity have less pain post surgery.

With the exception of pre-treatment pain, the pre-treatment factors tested in this study provide minimal guidance in identifying factors that might be modified to enhance patient outcome.

This prospective cohort study included one hundred and twenty-six patients (mean age=68.8 years, males: females=62:64) who had revision for other than infection or peri-prosthetic fracture. On average from pre-surgery to twenty-four months post-surgery, WOMAC pain improved 9.3 to 3.6 and physical function improved from 35.4 to 17.1. In univariate analysis (t-test, p< 0.05), males tended to have better function (19.6 vs. 14.7) and reported less pain (4.4 vs. 2.8). No other factors were significant in univariate analysis. None of the a priori factors noted above were independently predictive of patient function at twenty-four months in the multivariate model (F=2.06, p=0.04, R²=0.16). Decreased pain with activity at twenty-four months independently was predicted by having less pain pre surgery (p=0.01), being male (p=0.04) and having fewer comorbidities (p=0.07) in the multi-variate model (F=2.9. p=0.004, R²=0.21).

Funding: This work was supported by a grant from The Arthritis Society

We have evaluated the functional, clinical and radiological outcome of patients with simple and complex acetabular fractures involving the posterior wall, and identified factors associated with an adverse outcome.

We reviewed 128 patients treated operatively for a fracture involving the posterior wall of the acetabulum between 1982 and 1999. The Musculoskeletal Functional Assessment and Short-Form 36 scores, the presence of radiological arthritis and complications were assessed as a function of injury, treatment and clinical variables.

The patients had profound functional deficits compared with the normal population. Anatomical reduction alone was not sufficient to restore function. The fracture pattern, marginal impaction and residual displacement of > 2 mm were associated with the development of arthritis, which related to poor function and the need for hip replacement. It may be appropriate to consider immediate total hip replacement for patients aged > 50 years with marginal impaction and comminution of the wall, since 7 of 13 (54%) of these required early hip replacement.

A total of 179 adult patients with displaced intra-articular fractures of the distal radius was randomised to receive indirect percutaneous reduction and external fixation (n = 88) or open reduction and internal fixation (n = 91). Patients were followed up for two years. During the first year the upper limb musculoskeletal function assessment score, the SF-36 bodily pain sub-scale score, the overall Jebsen score, pinch strength and grip strength improved significantly in all patients. There was no statistically significant difference in the radiological restoration of anatomical features or the range of movement between the groups.

During the period of two years, patients who underwent indirect reduction and percutaneous fixation had a more rapid return of function and a better functional outcome than those who underwent open reduction and internal fixation, provided that the intra-articular step and gap deformity were minimised.

High-pressure lavage produces greater visible damage to bone at a macroscopic and microscopic level when compared with low-pressure lavage and can result in delay in the healing of fractures. Osteoblasts and adipocytes are derived from mesenchymal stem cells. Conditions which lead to bone loss often involve a switch from the osteoblast to adipocyte lineage. We have therefore examined the effect of high- and low-pressure irrigation on the differentiation of adipocytes.

Calvaria-derived bone cells were exposed to either low-pressure or high-pressure irrigation with normal saline. After 14 days the cells were fixed and the osteoblasts and adipocytes quantified using Oil Red O to stain cytoplasmic lipid droplets (triglycerides) in the cells. Osteoblasts were quantified using a commercially available alkaline-phosphatase staining assay.

A standard quantitative reverse transcription-polymerase chain reaction (RT-PCR) was performed. Messenger RNA levels for osteocalcin, a marker of osteoblasts, and PPARγ2, a marker of adipocytes, were measured. High-pressure lavage resulted in an increase in adipogenesis of 50% when compared with low-pressure lavage.

Our findings suggest that high-pressure lavage may promote differentiation of mesenchymal stem cells towards the adipoctye lineage. This may have clinical significance in the development of delayed and nonunion after treatment of fractures of long bones.

The reliability of the radiological assessment of the healing of tibial fractures remains undetermined. We examined the inter- and intraobserver agreement of the healing of such fractures among four orthopaedic trauma surgeons who, on two separate occasions eight weeks apart, independently assessed the radiographs of 30 patients with fractures of the tibial shaft which had been treated by intramedullary fixation. The radiographs were selected from a database to represent fractures at various stages of healing. For each radiograph, the surgeon scored the degree of union, quantified the number of cortices bridged by callus or with a visible fracture line, described the extent and quality of the callus, and provided an overall rating of healing.

The interobserver chance-corrected agreement using a quadratically weighted kappa (κ) statistic in which values of 0.61 to 0.80 represented substantial agreement were as follows: radiological union scale (κ = 0.60); number of cortices bridged by callus (κ = 0.75); number of cortices with a visible fracture line (κ = 0.70); the extent of the callus (κ = 0.57); and general impression of fracture healing (κ = 0.67). The intraobserver agreement of the overall impression of healing (κ = 0.89) and the number of cortices bridged by callus (κ = 0.82) or with a visible fracture line (κ = 0.83) was almost perfect.

There are no validated scales which allow surgeons to grade fracture healing radiologically. Among those examined, the number of cortices bridged by bone appears to be a reliable, and easily measured radiological variable to assess the healing of fractures after intramedullary fixation.

We have systematically reviewed the effect of alternative methods of stabilisation of open tibial fractures on the rates of reoperation, and the secondary outcomes of nonunion, deep and superficial infection, failure of the implant and malunion by the analysis of 799 citations on the subject, identified from computerised databases. Although 68 proved to be potentially eligible, only eight met all criteria for inclusion. Three investigators independently graded the quality of each study and extracted the relevant data.

One study (n = 56 patients) suggested that the use of external fixators significantly decreased the requirement for reoperation when compared with fixation with plates. The use of unreamed nails, compared with external fixators (five studies, n = 396 patients), reduced the risk of reoperation, malunion and superficial infection.

Comparison of reamed with unreamed nails showed a reduced risk of reoperation (two studies, n = 132) with the reamed technique. An indirect comparison between reamed nails and external fixators also showed a reduced risk of reoperation (two studies) when using nails.

We have identified compelling evidence that unreamed nails reduced the incidence of reoperations, superficial infections and malunions, when compared with external fixators. The relative merits of reamed versus unreamed nails in the treatment of open tibial fractures remain uncertain.

We reviewed 26 patients who had had internal fixation of an open intra-articular supracondylar fracture of the humerus. All operations were performed using a posterior approach, 13 with a triceps split and 13 with an olecranon osteotomy. The outcome was assessed by means of the Mayo Elbow score, the Disability of the Arm, Shoulder and Hand (DASH) score and the SF-36 Physical Function score. Patients with an olecranon osteotomy had less good results.

We randomised prospectively 44 patients with fractures of the shaft of the humerus to open reduction and internal fixation by either an intramedullary nail (IMN) or a dynamic compression plate (DCP). Patients were followed up for a minimum of six months. There were no significant differences in the function of the shoulder and elbow, as determined by the American Shoulder and Elbow Surgeons’ score, the visual analogue pain score, range of movement, or the time taken to return to normal activity. There was a single case of shoulder impingement in the DCP group and six in the IMN group. Of these six, five occurred after antegrade insertion of an IMN. In the DCP group three patients developed complications, compared with 13 in the IMN group. We had to perform secondary surgery on seven patients in the IMN group, but on only one in the DCP group (p = 0.016).

Our findings suggest that open reduction and internal fixation with a DCP remains the best treatment for unstable fractures of the shaft of the humerus. Fixation by IMN may be indicated for specific situations, but is technically more demanding and has a higher rate of complications.

Previous studies of the Ilizarov procedure have concentrated on musculoskeletal assessments rather than the opinions of patients. In a prospective trial of 25 consecutive patients, we evaluated the effect of Ilizarov reconstruction of post-traumatic deformity on general health status using the SF36 and Nottingham Health Profile (NHP).

The patients had very low preoperative scores, which remained low during treatment and correction, but increased postoperatively. The mean overall SF36 score improved from 36 ± 3 to 58 ± 7 (p = 0.031) and the NHP score from 39 ± 11 to 67 ± 10 (p = 0.002). The improvements in scores were not limited to the physical components and were equal or better than the improvements reported for other orthopaedic procedures, including total joint arthroplasty.

Ilizarov-type reconstruction of deformity of the lower limb not only restores bony configuration, but also produces a large improvement in the general health status of patients.

We examined the roles of methylmethacrylate (MMA) monomer and cementing technique in the formation, and haemodynamic outcome, of pulmonary fat emboli. The preparation of the femoral canal and the cementing technique were studied in four groups of adult dogs as follows: control (no preparation); lavage; cement pressurisation; and cement pressurisation after lavage. We measured the intramedullary pressure, pulmonary artery pressure (PAP), pulmonary capillary wedge pressure and bilateral femoral vein levels of triglyceride, cholesterol and MMA monomer at rest and after reaming, lavage, and cementing.

Femoral vein triglyceride and cholesterol levels did not vary significantly from resting levels despite significant elevations in intramedullary pressure with reaming, lavage and cementing (p = 0.001). PAP was seen to rise significantly with reaming (p = 0.0038), lavage (p = 0.0031), cementing (p = 0.0024) and cementing after lavage (p = 0.0028) while the pulmonary capillary wedge pressure remained unchanged.

MMA monomer was detected in femoral vein samples when cement pressurisation was used. Intramedullary lavage before cementing had no significant effect on the MMA level. Haemodynamic evidence of pulmonary embolism was noted with reaming and intramedullary canal preparation, irrespective of the presence of MMA monomer. We found no relationship between MMA monomer level and intramedullary pressure, PAP or pulmonary capillary wedge pressure.

Our findings suggest that the presence of MMA monomer in femoral venous blood has no effect on the formation of fat emboli or their pulmonary haemodynamic outcome during cemented hip arthroplasty.