Randomised controlled trial of cemented and uncemented fixation of primary total hip replacement
In persons older than 50 undergoing total hip replacement surgery for primary osteoarthritis, is there any difference in hip pain and function at two years and longer-term follow-up with cemented versus cementless prosthesis fixation?
Professor Donald W Howie
80 participants
Jun 2, 1986
Interventional
Conditions
Summary
Uncemented porous coated prostheses were introduced in the early 1980s as a possible answer to the complications of loosening of cemented prostheses and osteolysis. At that time, there was a lack of comparative studies, there being only one published randomised controlled trial of cemented and uncemented THR. In that trial, worse early pain scores were reported for uncemented THR. Therefore a randomised controlled trial was undertaken to examine the hypothesis that there are no important differences in hip pain and function following cemented and uncemented primary total hip replacement for osteoarthritis in middle-aged patients.
Eligibility
Inclusion Criteria3
- Diagnosis of primary osteoarthritis of hip
- Minimum age of 50 years
- Aged less than 72 for males and 77 for females which were the population age cut-offs for a life expectancy of at least 10 years as of the start of the trial.
Exclusion Criteria7
- Previous surgery or trauma to the hip
- Previous infection of the hip
- Paget’s disease
- Acetabular dysplasia
- Known allergy to cobalt-chrome
- Medical conditions with resultant life expectancy of less than 10 years
- Unable to attend regular outpatient reviews for at least two years.
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Interventions
Uncemented total hip replacement surgery with a cobalt-chrome alloy porous coated hemispherical PCA acetabular component with two lateral fixation lugs for supplementary fixation (Howmedica International, London) and a collarless cobalt chrome alloy PCA femoral stem with sintered porous beads coating the proximal one third of the stem circumferentially (Howmedica International, London), performed using standard surgical tehniques and a posterior surgical approach. Patients monitored regularly following the procedure by clinical and radiographic review, including at 2 years for primary study hypothesis and over the long-term until revision of the components, death or lost-to-follow-up.
Locations(2)
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ACTRN12613000335796