Failure of the uncoated titanium ProxiLock femoral hip prosthesis.

UNLABELLED: New prostheses should be evaluated for stability and clinical performance. In a prospective randomized clinical trial, we implanted 22 titanium (Ti) and 20 hydroxyapatite-coated (HA) ProxiLock femoral hip prostheses during total hip arthroplasty in 42 patients. The patients were followed for 24 months with clinical, radiographic and radiostereometric analysis. Full weightbearing was allowed immediately postoperatively. One patient with a titanium stem was lost to followup. During the first two months, 34 of the 41 stems subsided and/or rotated towards retroversion, regardless of stem type. At the 24-month followup 35 of the 41 prostheses were either fully stabilized (16 HA and 11 Ti stems) or had clinical irrelevant migration (four HA and four Ti stems). Six Ti prostheses showed continuous migrations with maximums of 4.7 mm translation and 12.2 degrees retroversion; four of these were revised, the other two had no clinical complaints. CLINICAL RELEVANCE: The migration pattern we found indicates insufficient primary fixation of the ProxiLock stem in an immediate full weightbearing protocol. The HA coating improves the secondary stability of the prosthesis compared to the uncoated stem. Early migration is associated with an increased risk of possible future loosening and revision, and therefore we discontinued the use of this prosthesis. LEVEL OF EVIDENCE: Therapeutic Level I. See Guidelines for Authors for a complete description of levels of evidence.

RCT Entities:   Population Interventions Outcomes