Comparison of femoral component migration between Refobacin bone cement R and Palacos R + G in cemented total hip arthroplasty: A randomised controlled roentgen stereophotogrammetric analysis and clinical study.
OBJECTIVE
The widely used and well-proven Palacos R (a.k.a. Refobacin Palacos R) bone cement is no longer commercially available and was superseded by Refobacin bone cement R and Palacos R + G in 2005. However, the performance of these newly introduced bone cements have not been tested in a phased evidence-based manner, including roentgen stereophotogrammetric analysis (RSA).


METHODS
In this blinded, randomised, clinical RSA study, the migration of the Stanmore femoral component was compared between Refobacin bone cement R and Palacos R + G in 62 consecutive total hip arthroplasties. The primary outcome measure was femoral component migration measured using RSA and secondary outcomes were Harris hip score (HHS), Hip disability and Osteoarthritis Outcome Score (HOOS), EuroQol 5D (EQ-5D) and Short Form 36 (SF-36).


RESULTS
Femoral component migration was comparable between Refobacin bone cement R and Palacos R + G during the two-year follow-up period with an estimated mean difference of 0.06 mm of subsidence (p = 0.56) and 0.08° of retroversion (p = 0.82). Five hips (three Refobacin bone cement R and two Palacos R + G) showed non-stabilising, continuous migration; the femoral cement mantle in these hips, was mean 0.7 mm thicker (p = 0.02) and there were more radiolucencies at the bone-cement interface (p = 0.004) in comparison to hips showing stabilising migration. Post-operative HHS was comparable throughout the follow-up period (p = 0.62). HOOS, EQ5D, and SF-36 scores were also comparable (p-values > 0.05) at the two-year follow-up point.


CONCLUSIONS
Refobacin bone cement R and Palacos R + G show comparable component migration and clinical outcome during the first two post-operative years. Hips showing continuous migration are at risk for early failure. However, this seems to be unrelated to cement type, but rather to cementing technique. Cite this article: Bone Joint J 2016;98-B:1333-41.
Leiden University Medical Center, Albinusdreef 2, J11-R-70, Leiden, 2333 ZA, The Netherlands.
P
P
van der Voort
Leiden University Medical Center, Albinusdreef 2, J11-R-70, Leiden, 2333 ZA, The Netherlands.
E R
ER
Valstar
Leiden University Medical Center, Albinusdreef 2, J11-R-70, Leiden, 2333 ZA, The Netherlands.
B L
BL
Kaptein
Leiden University Medical Center, Albinusdreef 2, J11-R-70, Leiden, 2333 ZA, The Netherlands.
M
M
Fiocco
Leiden University Medical Center, Albinusdreef 2, J11-R-70, Leiden, 2333 ZA, The Netherlands.
H J L
HJ
van der Heide
Leiden University Medical Center, Albinusdreef 2, J11-R-70, Leiden, 2333 ZA, The Netherlands.
R G H H
RG
Nelissen
D000328:Adult; D000368:Aged; D019644:Arthroplasty, Replacement, Hip / Q000379:methods*; D001843:Bone Cements; D005260:Female; D005500:Follow-Up Studies; D005839:Gentamicins / Q000494:pharmacology*; D006621:Hip Joint / Q000000981:diagnostic imaging / Q000601:surgery*; D006622:Hip Prosthesis; D006801:Humans; D008297:Male; D008768:Methylmethacrylates / Q000494:pharmacology*; D008875:Middle Aged; D015207:Osteoarthritis, Hip / Q000175:diagnosis / Q000601:surgery*; D019904:Polymethyl Methacrylate / Q000494:pharmacology*; D011474:Prosthesis Design; D059869:Radiostereometric Analysis / Q000379:methods*; D012189:Retrospective Studies; D016037:Single-Blind Method
D001843:Bone Cements; D005839:Gentamicins; D008768:Methylmethacrylates; C529143:Palacos R+G; C030159:gentamicin-polymethylmethacrylate bead; D019904:Polymethyl Methacrylate
Bone cement; Randomised controlled trial; Roentgen stereophotogrammetric analysis; Total hip arthroplasty