A randomized study on migration of the Spectron EF and the Charnley flanged 40 cemented femoral components using radiostereometric analysis at 2 years

Background and purpose

We performed a randomized study to determine the migration patterns of the Spectron EF femoral stem and to compare them with those of the Charnley stem, which is regarded by many as the gold standard for comparison of implants due to its extensive documentation.

Patients and methods

150 patients with a mean age of 70 years were randomized, single-blinded, to receive either a cemented Charnley flanged 40 monoblock, stainless steel, vaquasheen surface femoral stem with a 22.2-mm head (n = 30) or a cemented Spectron EF modular, matte, straight, collared, cobalt-chrome femoral stem with a 28-mm femoral head and a roughened proximal third of the stem (n = 120). The patients were followed with repeated radiostereometric analysis for 2 years to assess migration.

Results

At 2 years, stem retroversion was 2.3° and 0.7° (p < 0.001) and posterior translation was 0.44 mm and 0.17 mm (p = 0.002) for the Charnley group (n = 26) and the Spectron EF group (n = 74), respectively. Subsidence was 0.26 mm for the Charnley and 0.20 mm for the Spectron EF (p = 0.5).

Interpretation

The Spectron EF femoral stem was more stable than the Charnley flanged 40 stem in our study when evaluated at 2 years. In a report from the Norwegian arthroplasty register, the Spectron EF stem had a higher revision rate due to aseptic loosening beyond 5 years than the Charnley. Initial stability is not invariably related to good long-term results. Our results emphasize the importance of prospective long-term follow-up of prosthetic implants in clinical trials and national registries and a stepwise introduction of implants.Femoral stem loosening in cemented total hip arthroplasty (THA) is a multifactorial process with different mechanisms (Gruen et al. 1979, Barrack 2000). Factors such as the material, design, and surface finish are of fundamental importance for the long-term performance of cemented femoral hip implants (Scheerlinck and Casteleyn 2006). The longevity of cemented femoral stems has been related to the quality, stability, and endurance of the bonding between stem and cement (Chang et al. 1998, Scheerlinck and Casteleyn 2006). Different femoral stem designs have been developed to obtain increased fixation at this interface, since debonding between the cement and stem is an important mechanism in the initiation of loosening (Jasty et al. 1991).The satin-finish Spectron femoral stem has been one of the best performing stems in the Swedish National Arthroplasty Register (Malchau et al. 2002). A modified, proximally roughened version of the Spectron stem, the Spectron EF (Smith and Nephew, Memphis, TN), was introduced in 1989 to enhance stem-cement bonding.The use of this implant gained increasing popularity, and in 2007 the Spectron EF stem used with the Reflection All-Poly acetabular cup (Smith and Nephew) was the most commonly used primary total hip prosthesis in Norway (Espehaug et al. 2009).The degree of migration during the first years after surgery has been shown to correlate with the long-term performance of joint prostheses (Kärrholm et al. 1994, Kobayashi et al. 1997). Radiostereometric analysis (RSA) allows the accurate measurement of implant movement and has been extensively used for measurement of the in vivo migration of implants (Kärrholm et al. 1997).An earlier prospective randomized study reported an increased revision rate of the Charnley stem compared to the satin-finished Spectron stem (Garellick et al. 1999). In the present randomized, controlled clinical trial we wanted to evaluate the early migration of the successor to this stem, the Spectron EF stem and to compare it to that of the Charnley stem using RSA. The null hypothesis was that the migration of the Spectron EF stem was equal to that of the Charnley prosthesis (DePuy International Ltd., Leeds, UK), which has the longest follow-up and the largest volume of documentation of implants used for primary total hip arthroplasty (Aamodt et al. 2004).