Comparative Analysis of Early Follow-up of Biologic Fixation and Cemented Stem Fixation for Femoral Tumor Prosthesis.

Objective: To compare the safety and efficacy between biologic fixation and traditional cement stems for the fixation of distal femoral prostheses for reconstruction following tumor resection.

Methods: Retrospective analysis was performed of patients who received a first distal femoral tumor prosthesis, with a rotating hinge, in the Department of Orthopaedic Oncology of Beijing Jishuitan Hospital between October 2011 and January 2016. Two hundred and sixty eligible cases were enrolled, with a cemented fixation used in 199 of these cases and a biologic fixation in 61 cases. Survival rates and survival time of prostheses were analyzed, with prosthetic failure considered as the endpoint event for survival time of the prosthesis. Kaplan-Meier survival curve and the log-rank test were used to compare survival rates between the two types of fixation methods, and factors that may affect the survival rate of prosthesis were evaluated.

Results: Of the 260 cases forming our study group, 138 were males and 122 females, with 102 males and 97 females in the cemented fixation group (mean age, 25.8 years; range, 8-72 years) and 36 males and 25 females in the biologic fixation group (mean age, 25.5 years; range, 12-59 years). Osteosarcoma was the most common type of tumor (188 cases, 72.3%), of which 145 cases (72.9%) were in the cemented and 45 cases (72.1%) in the biologic fixation group. Among the 260 cases enrolled into the study group, 13 patients were lost to follow-up. The average duration of follow-up for the remaining 247 cases was 28.8 months (median, 28.8 months; range, 4-61 months). The 3-year overall survival rate of prostheses was 87.2% for the biologic fixation group and 80.4% in the cemented fixation group (P = 0.389). The 3-year mechanical survival rate (excluding cases of infection and oncologic progression) was 100% for the biologic fixation and 97.6% for the cemented fixation group (P = 0.468). Complications were identified in 21 cases: 3 cases (5%) in the biologic and 18 cases (9.6%) in the cemented fixation group (P = 0.264). Two revisions were required in the cemented fixation group, but no revision was required in the biologic fixation group. A total of 10 patients required amputation after prosthesis implantation. Of these, 7 cases (4 cement and 3 biologic) were due to tumor recurrence; 3 cases were due to infection, with all cases occurring in the cement fixation group.

Conclusion: The current study provides a baseline reference for future mid-term to long-term follow-up, laying the foundation for further studies and comparison of the incidence of aseptic loosening of both types of prosthesis.