Purpose: Today, numerous functional outcome tools exist to assess the patient’s ability to carry out basic and instrumental activities of daily living. Furthermore, the increase in range of mobility measures reflect differences in rating scales, scores, administration and scoring options which make outcome results difficult to assess across trials. Because of the lack of consensus among investigators, we wanted to identify the citation patterns of the functional outcomes tools used by investigators in hip fracture RCTs. We believed that the lack of proper citation is an underlying factor in the diverse usage of outcome tools.

Method: We extracted the citations of disability tools from 59 Level 1 hip fracture RCTs. Disability was defined using the WHO classification (ICF). We excluded measures assessing body structure. The text and reference lists of the identified articles were screened in order to compile relevant literature on the instrument used in the RCT. Disability tools which were cited in the references were also compared to original development articles.

Results: Overall 68 different instruments were identified that measured disability in the hip fracture literature. According to ICF, 47 tools measured body function alone, 13 tools evaluated activity limitations and participation restriction and 8 were composite scoring systems. We found that 34.2% of the trials did not provide any citations to the tools assessing body function. In trials measuring activity and participation, 23.2% provided instrument citations. In trials using composite scoring systems, 19.4% of the trials provided instrument citations. All of the instrument citations when provided by the investigators were found to correspond to original development articles or trials.

Conclusion: The appropriate choice of a functional outcome instrument is fundamental in order to ensure that the results that are obtained reflect the patient. However, if citations of the indices and scales themselves are lacking, trial methodology and results could be informative but not replicated. In the future, we recommend that rigor in quality reporting include proper instrument citations.

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: The purpose of this study was to compare the effects of two types of stem/progenitor cells on the healing of critical sized bone defects in a rat model. Endothelial Progenitor Cells (EPCs), a novel cell type with previously demonstrated effects on angiogenesis in animal models of vascular disease, were compared to both a control group of no cell therapy, and a treatment group of Mesenchymal Stem Cells (MSCs). The hypothesis was that EPCs would demonstrate both superior bone healing and angiogenesis, when compared to the control group and MSC group.

Method: EPCs and MSCs were isolated from the bone marrow of syngeneic rats by differential culture and grown ex vivo for 10 days. Subsequently the cells were harvested, seeded on a gelfoam scaffold, and implanted into a 5mm segmental defect in a rat femur that had been stabilized with a plate and screws. Bone healing was assessed radiographically and by microCT. Angiogenesis was assessed by histology and physiologically, using laser doppler to assess blood flow in the bone and soft tissues. All animal protocols were approved by and performed in accordance with the St. Michael’s Hospital Animal Care Committee. ANOVA was used to test for significant differences between the groups, and a p-value of < 0.05 was considered statistically significant.

Results: The EPC (n=14) group demonstrated radiographic evidence of healing of the bone defect as early as 2 weeks, and all specimens were radiographically healed at 6 weeks. Both the control group (n=14) and the MSC group (n=14) showed no radiographic evidence of healing at 10 weeks. MicroCT comparison of the EPC group versus the control group showed significantly greater bone volume and density at the defect site (p< 0.001). More blood vessel formation was observed in the EPC group versus the control group on histology at 2 weeks. Laser Doppler assessment showed significantly more soft tissue and bone blood flow at 2 and 3 weeks in the EPC group versus the control group (p=0.021).

Conclusion: The results of this study demonstrate that EPCs are effective as cell-based therapy for healing critical sized bone defects in a rat model. In this model EPCs demonstrated superiority to MSCs with regard to bone healing. In addition, EPCs demonstrated superior angiogenesis over controls in a rat model of fracture healing. These results strongly suggest that EPCs are effective for therapeutic angiogenesis and osteogenesis in fracture healing. There is a clinical need for effective strategies in the management of traumatic bone defects and nonunions. Investigation into the use of MSCs as an effective alternative to autologous bone grafting has failed to translate into clinical use. It is possible that EPCs are more effective at the regeneration of bone in segmental defects because of their synergistic effect on angiogenesis and osteogenesis. Further research into EPC based therapies for fracture healing is warranted.

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: 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: 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: 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: 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: 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: 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: 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: 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.

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: 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.