Equivalent hip stem fixation by Hi-Fatigue G and Palacos R + G bone cement: a randomized radiostereometric controlled trial of 52 patients with 2 years’ follow-up

Background and purpose — Long-term fixation of cemented femoral stems relies on several factors including cement adhesion and fatigue. Hi-Fatigue is a newer third-generation bone cement with low-viscosity properties at room temperature, good mechanical strength, and stable bone–cement interface in a laboratory testing environment. Palacos bone cement has excellent 10-year survival and is considered gold standard. We compared stem subsidence after fixation with Hi-Fatigue and Palacos bone cements using radiostereometry.

Patients and methods — In a patient-blinded randomized controlled trial, 52 patients (30 women) at mean age 76 years (71–87) with osteoarthrosis and no osteoporosis received Hi-Fatigue G or Palacos R + G cement fixation of collarless, polished, double-tapered stems (CPT). Tantalum beads were inserted in the periprosthetic bone. Supine stereoradiographs were obtained postoperatively, 3 months, 6 months, 1 year, and 2 years after surgery. Oxford Hip Score (OHS) and VAS pain were recorded preoperatively and 1 and 2 years after surgery. Cement working times and properties were registered.

Results — At 2 years, mean stem subsidence of 1.12 mm (95% CI 0.96–1.29) for Hi-Fatigue and 1.19 mm (CI 1.03–1.34) for Palacos was similar. Likewise, stem version was comparable between cement groups. Mean OHS and VAS pain were similar between cement groups.

Cement working times were similar between cement groups, but the mean curing time was longer for Hi-Fatigue (13.7 min) than for Palacos (11.6 min).

Interpretation — We found similar and generally low migration of CPT femoral stems inserted with Hi-Fatigue and Palacos bone cement until 2 years’ follow-up, which indicates a good long-term survival of polished taper femoral stems inserted with both cement types.

Trial registration:ClinicalTrials.gov identifier: NCT01289834.