No abstract

First-generation highly crosslinked polyethylene (HXLPE) was developed to reduce polyethylene wear debris and subsequent osteolysis. Two thermal stabilization strategies were developed, annealing and remelting, to remove free radicals remaining in the polymer. Both types of HXLPEs have demonstrated better wear resistance to conventional polyethylene in hip arthroplasty. However, few studies have directly compared the mid- to long-term clinical outcomes of first-generation HXLPEs. We sought to address the following research questions: (1) is there a difference between the revision reasons for HXLPE formulations (annealed and remelted), (2) is there a difference in oxidation between annealed and remelted HXLPEs, (3) is there a difference in the linear penetration rate of annealed and remelted HXLPEs, and (4) does the formulation of first-generation HXLPEs affect the prevalence of osteolysis? A total of 129 first-generation HXLPE acetabular liners were collected in a multicenter retrieval program. These components were implanted for 5 or more years and were fabricated from annealed or remelted HXLPE. Reasons for revision, body mass index, age, sex, and activity levels were collected from medical records. Oxidation was measured at four regions of interest: bearing surface, backside surface, locking mechanism, and rim. Liner penetration was directly measured from retrievals using a micrometer. Osteolysis was reported in the operative notes by the revising surgeon and a thorough review of the operative notes and radiographs. Revision reasons included infection, instability, pain, and loosening. The annealed liners had higher oxidation indices than remelted liners. There was no difference in linear penetration rates between cohorts. There was no difference in osteolysis prevalence between cohorts. We found remelted HXLPE to be more oxidatively stable than annealed HXLPE but did not find a significant difference in the linear penetration rates or the prevalence of osteolysis. Our findings demonstrate sustained long-term wear resistance of both cohorts of HXLPE. We did not find evidence to support a long-term clinical difference between the formulations of HXLPE.

Lumbar fusion surgery has grown in popularity as a solution to lower back pain. Surgical site infection (SSI) is a serious complication of spinal surgery, affecting as high as 8.5% of the patient population. If the SSI cannot be eradicated with intravenous antibiotics, the next step is second surgery, which increases the cost imposed on the patient and extends recovery time. An implantable ultrasound-triggered polyether ether ketone device for the dispersal of antibiotics has been developed as a potential solution. In this study, the device was constructed of bioabsorbable medical grade polymer, enabling gradual degradation, and manufactured via fused filament fabrication (FFF). A novel bioabsorbable filament was manufactured and validated with gel permeation chromatography (GPC) and differential scanning calorimetry (DSC). The filament was consistent in molecular weight and thermal properties (p = 0.348 and p = 0.487, respectively). The filament was utilized for FFF of the device. Dimensional accuracy of the device was assessed with μCT analysis. Dimensional differences between the printed device and intended design were minimal. Degradation of raw material, filament, and the device was performed in accordance to ASTM F1635-16 for a month to determine how melting the material impacted the degradation properties. The degradation rate was found to be similar among the samples weeks one through three however, the raw material degraded at a slower rate by the final week (p = 0.039). This study demonstrated the feasibility of utilizing medical grade bioabsorbable polymers in FFF.