Abstract
Recently, new metallurgical techniques allowed the creation of 3D metal matrices for cementless acetabular components. Among several different products now available on the market, the Biofoam Dynasty cup (MicroPort Orthopedics® Inc., Arlington, TN, USA) uses an ultraporous Titanium technology but has never been assessed in literature. Coping with this lack of information, our study aims to assess its radiological osteointegration at two years in a primary total hip arthroplasty and compares it to a successful contemporary cementless acetabular cup.
This monocentric retrospective study includes 96 Dynasty Biofoam acetabular components implanted between March 2010 and August 2014 with a minimum 2 years radiographic follow-up. Previous acetabular surgery, any septic issue or re-operation for component malposition were exclusion criteria. They were compared to 96 THA using the Trident PSL matched for age, gender, BMI and follow-up. Presence of radiolucencies and sclerotic lines were described on AP pelvis views using the classification of DeLee and Charnley
There was no statistical difference between the two groups concerning demographics and mean follow-up (p> 0.05). Shell's anteversion was similar but inclination was greater in the biofoam group (p=0.006). 27,17% of the Biofoam shells presented radiolucencies in 2 zones or more and 0% of the Trident shells. 11,96% of Biofoam cups showed radiolucencies in the 3 zones of DeLee comparing to 0% of the Trident cups. There was no statistical difference between the Biofoam group (n=54/96) and the Trident PSL group (n=57/96) in pre-operative functional scores for both WOMAC subscales and SF-12. When evaluating last follow-up PROM's, no significant differences were found comparing the entirety of both groups, 56 Biofoam and 51 Trident PSL. No difference was found either when comparing Biofoam patients with ³ 2 zones of radiolucencies (n=15) to the whole Trident group (n=51).
This study raises concerns about radiologic evidence of osteointegration of the Biofoam acetabular cup. Nevertheless, these radiological findings do not find any clinical correlation considering clinical scores. Thus, it may question the real meaning of these high-rated radiolucencies, which at first sight reflect a poorer osteointegration. The first possible limitation with this study is an overinterpretation of the radiographs. Nevertheless, both observers were blinded regarding the patients groups and clinical outcomes and there was a strong inter-observer reliability. Although both cohorts were matched on their demographics and were similar on the cup anteversion, we noticed a slightly lower abduction angle in the Biofoam population. It could reduce the bone-implant coverage area and hence hinders the bony integration, but this difference was small and both groups remained in the Lewinneck security zone. Furthermore, even if patients were matched on age, gender, BMI and follow-up, other variables can influence early osteointegration (smoke status, osteoporosis) and have not been controlled even though we have no reasons to think their distribution could differ in the 2 groups.
The real clinical meaning of these findings remains unknown but serious concerns are raised about the radiographic osteointegration of the Dynasty Biofoam acetabular components. Concerns are all the more lawful that this implants aim to enhance osteointegration.
