Ceramic total hip arthroplasty in the United States: safety and risk issues revisited.

The advantages of all-alumina bearings are superb wear resistance, stability, and inertness demonstrated over 3 decades. The disadvantage is a small risk for brittle fracture, as described in this paper. Surveying the latest ceramic hip series reported in recent journal articles or presented at the 6th World Biomaterials Congress, we found 11 studies representing more than 35,000 cases followed for 3 to 25 years. There were 24 reported fractures. A unique survey of hip complications in the 1990s found a fracture risk of approximately 1.4 per 1000 ceramic balls used in the United States. A company database holding more than 2.5 million records described the overall fracture risk as 1 per 10,000 cases. Initial use of ceramic cup inserts indicated a 2% to 3% incidence of chipping during surgery. Beginning in 1997, the number of ceramic-metal cup-locking cases entered into a US Food and Drug Administration ceramics database was more than 2400, with no fractures reported by the FDA in July 2003.

Micro-wear features on unique 100-Mrad cups: two retrieved cups compared to hip simulator wear study.

We studied the micro-wear phenomena of unique, extensively cross-linked polyethylene cups (cross-linked with 1,000 kGy-irradiation) that had been used briefly in Japan. Two retrievals (at 15 years) came from the Japanese "SOM" hip system (implanted 1971-78). These were compared to a set of 0 kGy and 500-1,500 kGy cups run in our hip simulator. The polyethylene cups that had not been cross-linked had the greatest wear. The worn areas had a burnished appearance and were clearly separated from the unworn region by a distinct ridge-line. The worn areas had lost all machine tracks, showed a large amount of UHMWPE 'flow', and long PE fibrils. The associated surface rippling was degraded. These features were considered synonymous with severe polyethylene wear. In contrast, the worn areas in the very cross-linked cups had a visibly matte surface and no ridge-line. Micro-examination showed that the machine tracks were still present. Ripple formations were less obvious than in the cups that were not cross-linked, polyethylene surface fibrils were scarcer and all the fibrils were much smaller than in the cups that were not crosslinked. Our two retrieved cups and the simulator cups confirmed the greater wear-resistance of very cross-linked polyethylene. It should also be noted that the SOM cup design and processing were unique and differed greatly from that of modern polyethylene cups.

Stripe wear rates in alumina THR--comparison of microseparation simulator study with retrieved implants.

Alumina-on-alumina hip implants with microseparation were run in a hip simulator for comparison of the nonseparation simulator mode and retrievals. The 28-, 32-, and 36-mm Biolox-forte implants were run to 5 million cycles with the use of 50% newborn calf serum. Howmedica Osteonics Trident cups with titanium backing were used in all sets. In standard (STD) and microseparation (MSX) mode, the typical biphasic wear trend was evident, but the MSX test mode had much higher magnitudes. There was a 5-fold increase for run-in wear and up to a 35-fold increase in steady-state wear. The stripe wear on the ball formed early, but did not progress in grade beyond 0.6 Mc. The locations of the stripes were similar in retrieved and simulator balls. However, the stripes from the simulator were narrower than short-term retrievals and much narrower than some long-term retrievals. The long-term retrieved balls had a grade of wear greater than the simulators. In vivo a broader range of motion occurs and this may lead to the wider stripe observed on the retrievals. These observations suggested that simulators could produce the loading and kinematics similar to a patient walking but not necessarily the variety of motions possible in the in vivo situation.

Assessment of lumbar spinal canal stenosis by magnetic resonance phlebography.

There is evidence to suggest that cauda equina intermittent claudication is caused by local circulatory disturbances in the cauda equina as well as compression of the cauda equina. We evaluated the role of magnetic resonance phlebography (MRP) in identifying circulatory disturbances of the vertebral venous system in patients with lumbar spinal canal stenosis. Extensive filling defects of the anterior internal vertebral venous plexus were evident in patients with lumbar spinal canal stenosis ( n = 53), whereas only milder abnormalities were noted in patients with other lumbar diseases ( n = 16) and none in normal subjects ( n = 13). The extent of the defect on MRP correlated with the time at which intermittent claudication appeared. In patients with lumbar spinal canal stenosis, extensive defects of the internal vertebral venous plexus on MRP were noted in the neutral spine position, but the defect diminished with anterior flexion of the spine. This phenomenon correlated closely with the time at which intermittent claudication appeared. Our results highlight the importance of MRP for assessing the underlying mechanism of cauda equina intermittent claudication in patients with lumbar spinal canal stenosis and suggest that congestive venous ischemia is involved in the development of intermittent claudication in these patients.