Background: Hypersensitivity reactions are suspected to cause premature aseptic loosening in susceptible patients after total knee arthroplasty. In response, metal-free implants have been developed. The aim of this prospective, observational midterm study was the assessment of a completely metal-free ceramic knee replacement system as a concise follow-up of a previous report.
Methods: Thirty-eight patients, with anamnestic suspected or documented allergy to the metal used in prosthetic alloys, participated in this 4-year follow-up of the metal-free BPK-S (Peter Brehm) total knee replacement system with ceramic femoral and tibial components. Clinical assessment included Knee Society Score (KSS), Oxford Knee Score, Euro Quol-5D-Visual Analogue Scale (EQ-5D-VAS), and perioperative or postoperative complications and need for revision. The position of the implant, signs of loosening, and leg alignment were assessed radiographically.
Results: All postoperative clinical scores improved significantly from baseline to 48-month follow-up examination. The Oxford Knee Score improved from 39 to 15 points. The KSS improved from 99 to 195 points (the KSS knee score 42.5 to 96 and the KSS function score 60 to 100). The EQ-5D improved from 12 to 7 points; the EQ-VAS improved from 52.5 to 97 points. No allergic reactions could be detected. Radiologically, a median preoperative varus deformity of 5° improved to 0° at 4-year follow-up. Radiolucent lines appeared around uncemented areas with no clinical symptoms.
Conclusion: The fully metal-free BPK-S Integration ceramic knee replacement system exhibits excellent immuno-allergological compatibility, offering a safe option for patients with prior hypersensitivity reactions to metallic materials. Full cementation of all components is recommended to avoid radiolucent lines around the implant.
Keywords: ceramic; function; hypersensitivity; knee arthroplasty; outcome.
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