Pyrocarbon has been used for over 25 years in finger joint replacements. Excellent biocompatibility, material and wear properties make pyrocarbon ideal for an orthopaedic device.

Pyrocarbon implants incur significantly less wear to articular cartilage than metal implants. The pyrocarbon implant replacement device (PIR) was developed to treat focal chondral and osteochondral defects of the femoral condyles. The PIR is intended to treat defects not amenable to microfracture or similar regenerative techniques and those for which unicompartmental or total knee arthroplasty is not yet indicated. The purpose of this study was to evaluate the in vivo articular response to the PIR device and compare it to a similar device made from cobaltchromium (CoCr) device. In addition, bone fixation of the PIR device with and without hydroxyapatite (HA) coating was evaluated.

Nine adult bred-for-purpose beagles received bilateral 6mm medial condyle full thickness osteochondral defects. One defect was treated with a PIR device and the other an identical CoCr device. In addition, one HA-coated and one non-HA coated PIR device was placed unicortically in the lateral distal femurs of each animal. Three animals each were terminated at 12, 24, and 52 weeks postoperative. Non-decalcified histologic sections of the implanted condyles and decalcified sections of the medial tibia and meniscus were evaluated. The femoral condyle sections were graded using a modified scale of Kirker-Head (2006). Additionally, the bone– implant contact area was quantified. The tibia-meniscus sections were evaluated utilising a modified version of the ICRS Histological Visual Scale (2002). The lateral distal femur implants were mechanically tested in axial push-out to compare the bone-implant interface strength between the HA-coated and non-HA coated PIR devices.

The mean histologic grades for the tibia and meniscus were superior for surfaces that articulated against the pyrocarbon PIR device compared to the CoCr device at 12, 24 and 52 weeks. Over time, the mean histologic grades decreased with both materials; however, tibias that articulated with the CoCr device had the lowest mean grade at 52 weeks. There were little difference in bone contact 12 and 24 weeks between the pyrocarbon and the CoCr devices. At 52 weeks, less bone contact was observed compared to 12 and 24 weeks. Mechanical testing demonstrated that the HA-coating imparted a statically significant improvement in interface strength as well as greater direct bone contact to the implant.

The results of this study confirm that pyrocarbon provides an ideal surface for an implant that articulates with cartilage of the knee. Although adequate direct bone contact was observed, the addition of HA-coating imparted both superior initial and long term bone fixation. The PIR device is suitable for restoration of focal defects of the knee.

An unconstrained, articulating pyrocarbon cervical total disc replacement (TDR; Rescue, Biomet, US) has been developed. Pyrocarbon is a chemically inert form of carbon with an elastic modulus similar to bone. The long-term durability and wear resistance of pyrocarbon has been demonstrated in other orthopaedic devices. The purpose of this study was two-fold: to compare the wear of identical disc reaplcements fabricated from cobalt chrome (CoCr) and ultrahigh-molecular-weight-polyethylene (UHMWPE) to pyrocarbon and to compare the motion at index and motion segments before and after Rescue TDR.

Ten pyrocarbon and three CoCr-UHMWPE TDRs were subjected to 10 million cycles in 20 degrees of flexion–extension with 155N axial load in serum solution at 4.0Hz. One additional CoCr-UHMWPE couple was immersed in serum and loaded to 155 N. TDRs and serum solution were examined at 0, 2.5, 5, 7.5 and 10 million cycles to characterize wear. The surfaces were measured with a coordinate measuring machine prior to and after 10 million cycles. Serum solutions and time controlled serum-only controls were characterized for the quantity of wear debris using particle analysis. Nine cadaver cervical spines were placed through dynamic 2Nm cycles of flexion, extension, and lateral bending. Electromagnetic sensors recorded the motion of each vertebral body in response to applied loads. Total range of motion at the index and adjacent levels were determined for the intact spine and after TDR.

There was no significant difference in the pyrocarbon surface geometry after 10 million cycles or in the number of particles generated during testing compared to baseline (p > 0.05).

However, CoCr-UHMWPE devices displayed classic patterns of total joint wear. CoCr-UHMWPE wear couples had an initial increase in serum particles, followed by lower particle producing rates that gradually increased. The difference in mean UHMWPE wear particles at each interval was significantly greater than with the pyrocarbon TDR (all p< 0.05).

The mean total and dynamic ranges of flexion-extension and lateral bending after implantation of the Rescue TDR at the index level were not statistically significantly different from that of the intact spine (ANOVA: p > 0.05). Similarly, at the superior and inferior adjacent levels, the mean total and dynamic range of flexion-extension and lateral bending after implantation of the Rescue device were not statistically significantly different from the intact spine (ANOVA: p > 0.05).