Abstract
We evaluated an anatomical uncemented stem, SP-CL, (Static Physiologicus – CementLess) designed to facilitate insertion and to avoid stress concentration at solitary contact points in a randomized controlled trial, with use of the Corail stem as control. The SPÅ-Cl stem has been on the market since 2014 but is still not well documented.
79 patients (80 hips) were primarily recruited and 71 patients (72 hips, 36 SP-CL, 36 Corail) attended the last follow up at 2 years. The clinical evaluation included several types of PROMs with Oxford Hip Score (OHS) as primary outcome. In addition, repeated measurements of stem migration, changes in bone mineral density and development of radiolucencies were studied with RSA, DXA and conventional radiography.
At two years the Oxford Hip Score did not differ between the SP-CL and Corail stem (estimated mean difference: −0.70 (95% CI: −4.28 – 2.89). In both groups Oxford hip score had almost doubled at 3 months, continued to increase up to 6 months and was about equal at 2 years (SP-CL; median 46 (17–48), Corail; median 47 (19–48)). At 2 years the SP-CL stems showed a median distal migration of −0.23 (−5.2 – 0.1) and the Corail stems of − 0.11 (−4.4 – 0.4). The SP-CL stems showed slightly more loss of bone mineral density in Gruen region 7 (p = 0.003).
We found no difference in clinical results with use of either of the two stems. Bone mineral density loss tended to be higher with use of the SP-CL stem and the early subsidence tended to be more pronounced, which turned out to be compatible with about the same stem stability reached between 1 and 2 years. As a next step we think that the SP-CL stem should be studied in a multi-center setting, before accepted for general use.
