Interest around carbon/PEEK plates and nails has been raising. The elastic modulus close to the bone, the high load-carrying capacity and radiolucency make CFR/PEEK materials a potential breakthrough. In the literature, there are abundant data about CFR/PEEK plates in the treatment of proximal humerus, distal radius and distal fibula fractures. In patients affected by bone metastasis, CFR/PEEK nails were proved effective and safe with 12 months of follow-up. Very little is known about performances of CFR/PEEK nails in patients affected by other pathologies.
The aim of the study was to evaluate safety and efficacy of CFR/PEEK nails in the treatment of various pathological conditions. It was also investigated whatever radiolucency of this nails could lead to a more objective evaluation of bone callus or disease site.
In the study group were included 20 patients (22 bone segments) who underwent CFR/PEEK nail implantation (eight humerus, one tibia, nine femur and four knee arthrodesis). They were affected by pathological fractures, and in four cases, they required an arthrodesis of the knee. They were retrospectively evaluated considering nail failures and bone callus or disease progression (RUSH scores). Mean follow-up time was 11 months (min 6.8-max 20.3). In the control group were included patients treated with titanium nails in the same institution for the same pathologies. An interclass correlation coefficient (ICC) analysis was performed in both groups considering RUSH scores by two expert surgeon from two institution to assess whether radiolucency could lead to a more objective evaluation of disease or bone callus site.
The ICC of mean values between RUSH scores was 0.882 (IC 95%: 0.702-0.953) in the CFR/PEEK group, while it was 0.778 (IC 95%: 0.41-0.91) in the titanium group. Observers' evaluation showed a significantly higher obscuration by titanium nails than by CFR/PEEK nails. No osteosynthesis failures were reported in both groups.
Our results confirm the safety of CFR/PEEK nails in the short-medium term. The radiolucency of these materials led our observers to perform more objective evaluations of bone callus formation or disease progression compared to the titanium group given the higher ICC.
III Case-control therapeutic study.