A new bone adhesive candidate- does it work in human bone? An ex-vivo preclinical evaluation in fresh human osteoporotic femoral head bone.

INTRODUCTION: The fixation of small intraarticular bone fragments is clinically challenging and an obvious first orthopaedic indication for an effective bone adhesive. In the present study the feasibility of bonding freshly harvested human trabecular bone with OsSticR, a novel phosphoserine modified cement, was evaluated using a bone cylinder model pull-out test and compared with a commercial fibrin tissue adhesive. METHODS: Femoral heads (n=13) were collected from hip fracture patients undergoing arthroplasty and stored refrigerated overnight in saline medium prior to testing. Cylindrical bone cores with a pre-inserted bone screw, were prepared using a coring tool. Each core was removed and glued back in place with either the bone adhesive (α-tricalcium phosphate, phosphoserine and 20% trisodium citrate solution) or the fibrin glue. All glued bones were stored in bone medium at 37°C. Tensile loading, using a universal testing machine (5 kN load cell), was applied to each core/head. For the bone adhesive, bone cores were tested at 2 (n=13) and 24 (n=11) hours. For the fibrin tissue adhesive control group (n=9), bone cores were tested exclusively at 2 hours. The femoral bone quality was evaluated with micro-CT. RESULTS: The ultimate pull-out load for the bone adhesive at 2 hours ranged from 36 to 171 N (mean 94 N, SD 42 N). At 24 hours the pull-out strength was similar, 47 to 198 N (mean 123 N, SD 43 N). The adhesive failure usually occurred through the adhesive layer, however in two samples, at 167 N and 198 N the screw pulled out of the bone core. The fibrin tissue adhesive group reached a peak force of 8 N maximally at 2 hours (range 2.8-8 N, mean 5.4 N, SD 1.6 N). The mean BV/TV for femoral heads was 0.15 and indicates poor bone quality. CONCLUSION: The bone adhesive successfully glued wet and fatty tissue of osteoporotic human bone cores. The mean ultimate pull-out force of 123 N at 24 hours corresponds to ∼ 300 kPa shear stress acting on the bone core. These first ex-vivo results in human bone are a promising step toward potential clinical application in osteochondral fragment fixation.

Trochanteric fracture-implant motion during healing - A radiostereometry (RSA) study.

Cut-out complication remains a major unsolved problem in the treatment of trochanteric hip fractures. A better understanding of the three-dimensional fracture-implant motions is needed to enable further development of clinical strategies and countermeasures. The aim of this clinical study was to characterise and quantify three-dimensional motions between the implant and the bone and between the lag screw and nail of the Gamma nail. Radiostereometry Analysis (RSA) analysis was applied in 20 patients with trochanteric hip fractures treated with an intramedullary nail. The following three-dimensional motions were measured postoperatively, at 1 week, 3, 6 and 12 months: translations of the tip of the lag screw in the femoral head, motions of the lag screw in the nail, femoral head motions relative to the nail and nail movements in the femoral shaft. Cranial migration of the tip of the lag screw dominated over the other two translation components in the femoral head. In all fractures the lag screw slid laterally in the nail and the femoral head moved both laterally and inferiorly towards the nail. All femoral heads translated posteriorly relative to the nail, and rotations occurred in both directions with median values close to zero. The nail tended to retrovert in the femoral shaft. Adverse fracture-implant motions were detected in stable trochanteric hip fractures treated with intramedullary nails with high resolution. Therefore, RSA method can be used to evaluate new implant designs and clinical strategies, which aim to reduce cut-out complications. Future RSA studies should aim at more unstable fractures as these are more likely to fail with cut-out.

Three-dimensional bone-implant movements in trochanteric hip fractures: Precision and accuracy of radiostereometric analysis in a phantom model.

The accuracy and precision of RSA were evaluated in the experimental study of screw cut-out complication after fixation of trochanteric fractures. A plastic bone model of a two-part trochanteric fracture was constructed with a Gamma nail implant incorporating RSA markers. The femoral head fragment was attached to a separate rotational table and the femoral shaft was mounted on the micrometer. Three main motions were simulated: Femoral head translation and rotation along the axis of the lag screw and fracture fragment translation along anatomical axes. Accuracy and precision were determined according to ISO 16,087 and ASTM standard F2385-04. Translations along the lag screw axis were measured with a precision within ±0.14 mm and an accuracy within ±0.03 mm. With simultaneous translations along all three anatomical axes, lowest precision was measured for the x-axis (±0.29, 0.07 mm, respectively), but improved when analyzed as a vector (±0.08, 0.03 mm). The precision and accuracy of femoral head rotations were within 0.5° and 0.18°, respectively. The resolution of the RSA method tested in this model was high, though it varied depending on the type of analyzed motion. This information is valuable when selecting and interpreting outcome parameters evaluating implant migration and osteosynthesis stability in future clinical RSA studies.

Critical factors in cut-out complication after Gamma Nail treatment of proximal femoral fractures.

BACKGROUND: The most common mechanical failure in the internal fixation of trochanteric hip fractures is the cut-out of the sliding screw through the femoral head. Several factors that influence this complication have been suggested, but there is no consensus as to the relative importance of each factor. The purpose of this study was to analyse the cut-out complication with respect to the following variables: patients' age, fracture type, fracture reduction, implant positioning and implant design. METHODS: 3066 consecutive patients were treated for trochanteric fractures with Gamma Nails between 1990 and 2002 at the Centre de Traumatologie et de l'Orthopedie (CTO), Strasbourg, France. Cut-out complications were identified by reviewing all available case notes and radiographs. Subsequently, the data were analysed by a single reviewer (AJB) with focus on the studied factors. RESULTS: Seventy-one cut-out complications were found (2.3%) of the 3066 trochanteric fractures. Cut-out failure associated with avascular head necrosis, pathologic fracture, deep infection or secondary to prior failure of other implants were excluded from the study (14 cases). The remaining 57 cases (1.85%, median age 82.6, 79% females) were believed to have a biomechanical explanation for the cut-out failure. 41 patients had a basicervical or complex fracture type. A majority of cut-outs (43 hips, 75%) had a combination of the critical factors studied; non-anatomical reduction, non-optimal lag screw position and the characteristic fracture pattern found. CONCLUSIONS: The primary cut-out rate of 1.85% was low compared with the literature. A typical cut-out complication in our study is represented by an unstable fracture involving the trochanteric and cervical regions or the combination of both, non-anatomical reduction and non-optimal screw position. Surgeons confronted with proximal femoral fractures should carefully scrutinize preoperative radiographs to assess the primary fracture geometry and fracture classification. To reduce the risk of a cut-out it is important to achieve both anatomical reduction and optimal lag screw position as these are the only two factors that can be controlled by the surgeon.

3066 consecutive Gamma Nails. 12 years experience at a single centre.

BACKGROUND: Fixation of trochanteric hip fractures using the Gamma Nail has been performed since 1988 and is today well established and wide-spread. However, a number of reports have raised serious concerns about the implant's complication rate. The main focus has been the increased risk of a subsequent femoral shaft fracture and some authors have argued against its use despite other obvious advantages, when this implant is employed. Through access to a uniquely large patient data base available, which is available for analysis of trochanteric fractures; we have been able to evaluate the performance of the Gamma Nail over a twelve year period. METHODS: 3066 consecutive patients were treated for trochanteric fractures using Gamma Nails between 1990 and 2002 at the Centre de Traumatologie et de l'Orthopedie (CTO), Strasbourg, France. These patients were retrospectively analysed. Information on epidemiological data, intra- and postoperative complications and patients' outcome was retrieved from patient notes. All available radiographs were assessed by a single reviewer (AJB). RESULTS: The results showed a low complication rate with the use of the Gamma Nail. There were 137 (4.5%) intraoperative fracture-related complications. Moreover 189 (6.2%) complications were detected postoperatively and during follow-up. Cut-out of the lag screw from the femoral head was the most frequent mechanical complication (57 patients, 1.85%), whereas a postoperative femoral shaft fracture occurred in 19 patients (0.6%). Other complications, such as infection, delayed healing/non-union, avascular femoral head necrosis and distal locking problems occurred in 113 patients (3.7%). CONCLUSIONS: The use of the Gamma Nail in trochanteric hip fractures is a safe method with a low complication rate. In particular, a low rate of femoral shaft fractures was reported. The low complication rate reported in this series can probably be explained by strict adherence to a proper surgical technique.