Background: This study was designed to compare the fixation of a Mallory-Head total hip prosthesis with and without cement.

Methods: Two hundred and fifty patients with osteoarthritis of the hip were randomized to receive a Mallory-Head total hip prosthesis designed for insertion with cement or the same prosthesis designed for insertion without cement. Neither the patient nor the outcomes assessor was aware of the type of prosthesis. Outcomes were assessed with respect to mortality, revision arthroplasty, health-related quality of life (evaluated with the Harris hip score, Merle d'Aubigné and Postel hip score, McMaster-Toronto Arthritis Patient Preference Disability Questionnaire (MACTAR), Western Ontario and McMaster University Osteoarthritis Index (WOMAC), and the time trade-off technique), and the six-minute-walk test. Patients were seen at three, six, and twelve months and yearly thereafter.

Results: The prosthesis was inserted with cement in 124 patients and without cement in 126 patients. The mean age of the patients was sixty-four years, 48% were female, and the mean duration of follow-up was 6.3 years. There were thirteen revisions in the group that had fixation with cement and six in the group that had fixation without cement (p = 0.11), and more femoral components were revised in the group that had fixation with cement (twelve versus one; p = 0.002). All health-related quality-of-life measures improved postoperatively in both groups.

Conclusions: In this randomized trial, the group that had the cemented Mallory-Head hip prostheses required more revisions of the femoral component than did the group with the cementless Mallory-Head prostheses, which was perhaps related to the titanium-alloy femoral stem. Our findings are specific to the implants evaluated in this study.