title: Early Subsidence Predicts Failure of a Cemented Femoral Stem With Minor Design Changes.
abstract: BACKGROUND
  Radiostereometry (RSA) measurements of early micromotion can predict later failure in hip and knee prostheses. In hip implants, RSA has been particularly helpful in the evaluation of composite-beam stem designs. The Spectron EF Primary stem (Smith & Nephew, London, UK) has shown inferior performance compared with its predecessors in both clinical studies and registry reports. Early RSA studies have shown somewhat greater subsidence for the Spectron EF Primary stem compared with the earlier Spectron EF, but still within boundaries considered to be safe.
  
  
  OBJECTIVE
  Our primary research question was whether stem subsidence and rotation for this stem design measured with RSA at 2 years can predict later stem failure. A secondary question was whether high femoral stem offset and small stem sizes, both features specific to the Spectron EF Primary stem compared with its predecessors, are associated with stem failure rate.
  
  
  METHODS
  Two hundred forty-seven hips (209 patients with median age 63 years [range, 29-80 years], 65% female, and 77% primary osteoarthritis) with a valid RSA examination at 2 years were selected from four different RSA studies (totaling 279 hips in 236 patients) in our department. The studies were primarily aimed at evaluating cup fixation, bone cement, and polyethylene types. All study patients received a cemented Spectron EF Primary stem. The selected hips had complete followup until stem failure, death, or the end of the followup period. Stem failure was defined as revision of a loose femoral stem or radiological failure with significant osteolysis in Gruen zones 2 to 6. Cox regression analyses were performed to evaluate if stem subsidence and rotation after 2 years, adjusted for age, sex, stem size, standard/high stem offset, and conventional/highly crosslinked polyethylene, could predict later clinical aseptic failure of the stem. We identified 32 stem failures (27 revisions, five radiological failures) at 14 years median followup (range, 3-18 years). Ten-year stem survival was 94% (95% confidence interval [CI], 90%-96%).
  
  
  RESULTS
  Stem subsidence at 2 years (adjusted hazard ratio [HR], 6.0; 95% CI, 2.5-15; p < 0.001) and retrotorsion of the stem (adjusted HR, 1.7; 95% CI, 1.1-2.5; p = 0.018) were associated with later stem failure. Further risk factors were male sex (subsidence analysis HR, 6.9; p > 0.001), use of the two smallest stem sizes (HRsize 1, 8.0; p > 0.001, HRsize 2, 1 [reference], HRsize 3+, 0.06; p = 0.035), and the high offset option (HR, 3.1; p = 0.005).
  
  
  CONCLUSIONS
  Stem subsidence and retrotorsion at 2 years can predict later failure in the Spectron EF Primary stem, consistent with earlier findings on composite-beam cemented stems. Small stem size and high-offset stems comprise the main group of underperforming stems. We recommend that premarket small-scale RSA studies be performed after any design change to a THA femoral component, because even seemingly minor design changes may unexpectedly result in inferior performance.
  
  
  METHODS
  Level III, therapeutic study.
authors.affiliation: Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. per-erik.johanson@vgregion.se.|Sahlgrenska University Hospital/Sahlgrenska, 413 45, Gothenburg, Sweden. per-erik.johanson@vgregion.se.
authors.forename: Per-Erik
authors.initials: PE
authors.lastname: Johanson
authors.affiliation: Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
authors.forename: Martin
authors.initials: M
authors.lastname: Antonsson
authors.affiliation: Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
authors.forename: Bita
authors.initials: B
authors.lastname: Shareghi
authors.affiliation: Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
authors.forename: Johan
authors.initials: J
authors.lastname: Kärrholm
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019644:Arthroplasty, Replacement, Hip / Q000009:adverse effects / Q000295:instrumentation*; D001696:Biomechanical Phenomena; D005260:Female; D005269:Femur / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D006621:Hip Joint / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D006622:Hip Prosthesis; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D011475:Prosthesis Failure; D059869:Radiostereometric Analysis; D018570:Risk Assessment; D012307:Risk Factors; D012399:Rotation; D013997:Time Factors; D016896:Treatment Outcome