title: First clinical study of a novel complete metal-free ceramic total knee replacement system.
abstract: BACKGROUND
  The aim of the study was to evaluate the safety and efficacy of a novel metal-free ceramic total knee replacement system.
  
  
  METHODS
  Thirty-eight primary total knee arthroplasties (TKAs) were performed on 34 patients using the metal-free BPK-S ceramic total knee replacement system with both the femoral and tibial components of an alumina/zirconia ceramic composite. The clinical outcome was evaluated pre- and postoperatively at 3 (n = 32 TKA) and 12 months (n = 32 TKA) using the Knee Society Score (KSS), the Oxford Knee Score and the EQ-5D. Safety analysis was performed by radiological examination and assessment of adverse events.
  
  
  RESULTS
  Postoperatively, the KSS, Oxford Knee Score and EQ-5D improved significantly at 3 and 12 months (p < 0.001). Non-progressive partial radiolucent lines were observed in six cases, but there was no osteolysis and no implant loosening. Induction or exacerbation of allergies did not occur during the follow-up.
  
  
  CONCLUSIONS
  The metal-free BPK-S ceramic total knee replacement system proved to be a safe and clinically efficient alternative to metal implants in this short-term follow-up study.
authors: Department of Orthopaedic and Trauma Surgery, University Hospital Erlangen, Krankenhausstr. 12, 91054, Erlangen, Germany. eva.meier@uk-erlangen.de.
authors: E
authors: E
authors: Meier
authors: Department of Orthopaedic and Trauma Surgery, University Hospital Erlangen, Krankenhausstr. 12, 91054, Erlangen, Germany.
authors: K
authors: K
authors: Gelse
authors: Hospital Wels, Grieskirchnerstr. 42, A-4600, Wels, Austria.
authors: K
authors: K
authors: Trieb
authors: Department of Orthopaedic and Trauma Surgery, University Hospital Erlangen, Krankenhausstr. 12, 91054, Erlangen, Germany.
authors: M
authors: M
authors: Pachowsky
authors: Department of Orthopaedic and Trauma Surgery, University Hospital Erlangen, Krankenhausstr. 12, 91054, Erlangen, Germany.
authors: F F
authors: FF
authors: Hennig
authors: Department of Orthopaedic and Trauma Surgery, University Hospital Erlangen, Krankenhausstr. 12, 91054, Erlangen, Germany.
authors: A
authors: A
authors: Mauerer
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000537:Aluminum Oxide; D019645:Arthroplasty, Replacement, Knee / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D002516:Ceramics; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007719:Knee Joint / Q000000981:diagnostic imaging; D007720:Knee Prosthesis / Q000009:adverse effects; D008297:Male; D008670:Metals; D008875:Middle Aged; D011474:Prosthesis Design; D015040:Zirconium
chemical_list: D008670:Metals; D015040:Zirconium; D000537:Aluminum Oxide; C028541:zirconium oxide