Healthcare technology and technology assessment.

New technology is one of the primary drivers for increased healthcare costs in the United States. Both physician and industry play important roles in the development, adoption, utilization and choice of new technologies. The Federal Drug Administration regulates new drugs and new medical devices, but healthcare technology assessment remains limited. Healthcare technology assessment originated in federal agencies; today it is decentralized with increasing private sector efforts. Innovation is left to free market forces, including direct to consumer marketing and consumer choice. But to be fair to the consumer, he/she must have free knowledge of all the risks and benefits of a new technology in order to make an informed choice. Physicians, institutions and industry need to work together by providing proven, safe, clinically effective and cost effective new technologies, which require valid pre-market clinical trials and post-market continued surveillance with national and international registries allowing full transparency of new products to the consumer--the patient.

Mechanical testing of bioresorbable implants for use in metacarpal fracture fixation.

The purpose of this study was to evaluate the mechanical properties of a bioresorbable plate and screw system that was developed for the treatment of unstable metacarpal fractures and to compare the strength and stiffness of this system with those of conventional titanium plates and screws. Using a 4-point bending test, we measured the strength and stiffness of these implants over a 12-week period of in vitro degradation. Our data suggest that these implants provide stable bending strength and stiffness for 8 weeks and gradually lose their strength over a period of 12 weeks. Further research is necessary to determine whether this level of fixation is adequate to stabilize unstable metacarpal fractures.

In vivo evaluation of coralline hydroxyapatite and direct current electrical stimulation in lumbar spinal fusion.

STUDY DESIGN: An animal model of posterolateral intertransverse process lumbar spinal fusion using autologous bone, coralline hydroxyapatite, and/or direct current electrical stimulation. OBJECTIVES: To evaluate the effect of an osteoconductive bone graft substitute and direct-current electrical stimulation on the rate of pseudarthrosis in a rabbit spinal fusion model. SUMMARY OF BACKGROUND DATA: Conventional techniques for the surgical treatment of degenerative conditions in the lumbar spine have a substantial failure rate and associated morbidity. Bone graft substitutes and electrical stimulation are alternative techniques to enhance fusion rates and limit the morbidity associated with posterolateral intertransverse process fusion using autologous iliac crest bone graft. METHODS: Fifty-three adult female New Zealand White rabbits underwent single-level lumbar posterolateral intertransverse process fusion. Animals were assigned to one of four groups using either autologous bone (Group I), coralline hydroxyapatite with autologous bone marrow aspirate (Group II), coralline hydroxyapatite with a 40-microA implantable direct current electrical stimulator and bone marrow aspirate (Group III), or coralline hydroxyapatite with a 100-microA implantable direct current electrical stimulator and bone marrow aspirate (Group IV). Animals were killed at 8 weeks, and fused motion segments were subjected to manual palpation, mechanical testing, and radiographic and histologic analysis to assess the fusion mass. RESULTS: Successful fusion was achieved in 57% (8/14) of animals in Group I, 25% (3/12) in Group II, 50% (6/12) in Group III, and 87% (13/15) in Group IV. Mean stiffness and ultimate load to failure were significantly higher in Group IV than in all other groups (P < 0.05). Histologic analysis demonstrated a qualitative increase in fusion mass in Group IV versus all other groups. CONCLUSIONS: Direct-current electrical stimulation increased fusion rates in a dose-dependent manner in a rabbit spinal fusion model. Coralline hydroxyapatite is an osteoconductive bone graft substitute, and thus requires an osteoinductive stimulus to ensure reliable fusion rates. Furthermore, coralline hydroxyapatite and direct current electrical stimulation can be used together to increase fusion rates in a rabbit spinal fusion model while avoiding the morbidity associated with harvesting iliac crest bone.

Survivorship analysis of hips treated with core decompression for nontraumatic osteonecrosis of the femoral head.

We reviewed the long-term results of core decompression for the treatment of nontraumatic osteonecrosis of the femoral head, performed in thirty-four patients (fifty-four hips) between January 1, 1981, and June 30, 1995. Twenty patients (59 percent) had bilateral involvement. The mean age of the patients at the time of presentation was thirty-eight years (range, twenty-two to eighty-three years). The presumed risk factors were use of corticosteroids (thirty-seven hips), excessive intake of alcohol (eight hips), and use of adrenocorticotropic hormone for the treatment of multiple sclerosis (two hips); the remaining seven hips had idiopathic osteonecrosis. According to a modification of the classification system of Ficat and Arlet in combination with the system of Steinberg et al., thirteen hips were stage I (normal radiographs) preoperatively; seven, stage IIA sclerotic; sixteen, stage IIA cystic or sclerocystic; ten, stage IIB (transitional stage, with a crescent sign); and eight, stage III (collapse). The mean duration of follow-up after the core decompression was 120 months (range, twenty-four to 196 months). The result was considered successful if the patient was asymptomatic, with no progression of the disease, and unsuccessful if there was radiographic failure (progression to stage III [collapse]) or clinical failure (the need for a subsequent operation), or both. The Kaplan-Meier product-limit method was used to estimate clinical and radiographic survival. Overall, twenty-six hips (48 percent) had a satisfactory clinical result and twenty (37 percent) survived according to radiographic criteria. Radiographic or clinical failure, or both, were seen in four of the thirteen stage-I hips, none of the seven stage-IIA sclerotic hips, thirteen of the sixteen stage-IIA cystic or sclerocystic hips, nine of the ten stage-IIB hips, and all eight stage-III hips. On the basis of the Cox proportional-hazards regression model, significant predictors of overall failure included an advanced preoperative radiographic stage (p < 0.0001), a shorter duration of symptoms (p < 0.05), and use of corticosteroids (p < 0.05). No association was found between age, gender, excessive intake of alcohol, or renal transplantation and the overall outcome. Two patients (two hips; 4 percent) had a postoperative complication. One patient had a fracture of the femoral neck, and the other had a hematoma. Our findings suggest that core decompression is a safe and effective procedure for the treatment of stage-I or stage-IIA sclerotic disease. These data also demonstrate the importance of differentiating between stage-IIA sclerotic disease and stage-IIA cystic or sclerocystic disease. We believe that core decompression has a limited role in the operative management of patients who have evidence of cystic changes in the femoral head on plain radiographs.

Radiographic appearance of the normal distal tibiofibular syndesmosis in children.

In adults, a tibiofibular clear space (i.e., distance from the incisura fibularis to the medial fibula) of > or = 6 mm or a loss of tibiofibular overlap has been reported to correlate with injury to the distal tibiofibular syndesmosis. We reviewed anteroposterior (AP), lateral, and mortise ankle radiographs from 106 children (50 boys, 56 girls) aged 1-15 years in an attempt to assess whether these criteria are applicable to children. The incisura was detectable at a mean age of 8.2 years for girls and 11.2 years for boys. The range of tibiofibular clear space among the 48 children with a detectable incisura was 2-8 mm; seven (23%) of these 48 children had a clear space of > or = 6 mm in one or more views. The mean age at which the tibiofibular overlap began to appear on the AP view was 5 years for both genders, whereas on the mortise view, it was 10 years for girls and 16 years for boys. The criteria used to evaluate the integrity of the distal tibiofibular syndesmosis in adults do not apply to children in this normal study population.

Three-dimensional finite element modeling of a cervical vertebra: an investigation of burst fracture mechanism.

Finite element modeling was used to study the mechanical behavior of a cervical vertebra under axial compressive loading. A three-dimensional (3-D) finite element (FE) model of a mid-cervical vertebra using inhomogeneous material properties was generated from quantitative computed tomographic (CT) scan data. This model improved upon previous vertebral FE models by using a highly refined mesh to represent the 3-D variation in material properties of vertebral bone. Traumatic loading of the vertebra was simulated by applying an axial compressive displacement through linear spring elements. Bone strength was computed from the CT scan data and compared with predicted stress. Based on the maximum shear stress theory of failure, the model predicts initiation of failure in the central cancellous region of the vertebral body. The type of fracture pattern predicted by the model is consistent with the typical cervical burst fracture that is seen clinically after compressive loading of the cervical spine. As such, we have developed a tool that can be useful for validating proposed fracture mechanisms in the cervical spine.