None listed
Conditions
Brief 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.
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 f
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.
Sponsors
Professor Donald W Howie
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to 77 Years
Healthy volunteers
No
Inclusion criteria
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 criteria
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.
Outcome results
None listed