Molded, Gamma-radiated, Argon-processed Polyethylene Components of Rotating Hinge Knee Megaprostheses Have a Lower Failure Hazard and Revision Rates Than Air-sterilized, Machined, Ram-extruded Bar Stock Components.

BACKGROUND Megaprostheses are commonly used for reconstruction after distal femoral resection in orthopaedic oncology. The polyethylene bearings in these reconstructions experience wear and wear-related complications that may result in revision surgery. Improved manufacturing and processing of polyethylene has increased the durability of components commonly used for routine arthroplasty. Alterations in the manufacture of polyethylene is expected to reduce the revision risk of oncologic megaprostheses, resulting in fewer revision procedures, but this has not been proven. QUESTIONS/PURPOSES Is there a difference in the hazard of polyethylene wear or breakage leading to prosthetic revision between differences in polyethylene manufacture and processing based on a competing risk analysis? METHODS This was a single-center, observational, retrospective comparative study of 224 patients who had distal femur megaprostheses with identical rotating hinge articulations and knee kinematics after oncologic surgery from 1993 to 2015. No differences in surgical indications, joint articular components and kinematics, age, sex, diagnosis, BMI, use of chemotherapy, or tumor stage were seen with the patient numbers available. Prosthetic survivorship free from prosthetic revision surgery because of polyethylene wear-related revisions, defined as breakage, increased excursion on varus-valgus stress, or new locking or giving way was compared between two groups of patients: group 1 polyethylene (P1) (66 patients) who had air-sterilized machined ram-extruded bar stock or group 2 polyethylene (P2) (158 patients) molded gamma-radiated argon-processed polyethylene components. The mean follow-up duration for the P1 group (89 ± 55 months) was not different from that of patients with P2 polyethylene (79 ± 63 months; p = 0.24) including 27% (18 of 66) of patients in the P1 group and 25% (40 of 158) of patients in the P2 group followed for more than 10 years. More patients in the P2 group were lost to follow-up (9.2%, 16 of 174) than in the P1 group (5.7%, 4 of 70) but this was not statistically different (chi square; p = 0.37). The hazard of revision because of polyethylene wear or breakage was calculated with a competing risk analysis using the Fine-Gray subdistribution hazard model. RESULTS The P1 implants had a higher hazard ratio for revision caused by polyethylene damage at 120 months than did the P2 polyethylene implants (P1 HR 0.24 [95% CI 0.13 to 0.36] versus HR 0.07 [95% CI 0.03 to 0.12]), which represents an estimated absolute risk reduction of 17% (95% CI 6.15 to 27.9). CONCLUSION Polyethylene damage can result in megaprosthetic revisions in patients undergoing oncologic procedures. The hazard of polyethylene failure resulting in revision surgery was lower in patients who received recent polyethylene than in patients with polyethylene produced by previous methods, enhancing the durability of distal femoral megaprosthetic reconstructions. Despite improvements in polyethylene manufacture and clinical results, revision solely because of polyethylene damage still occurs in 7% of patients by the 10-year timepoint; thus, more improvement is needed. Patients who receive these implants should be monitored for signs and symptoms of polyethylene damage. LEVEL OF EVIDENCE Level III, therapeutic study.