None listed
Conditions
Brief summary
Primary fixation of the acetabular cup in total hip arthroplasty is vital for long-term stability. In cementless press-fit cups, this initial stability is achieved by the press-fit fixation. Additional primary fixation may be obtained by the use of extra screws. However, the value of additional screw fixation of press-fit acetabular cup implants on implant survival is questioned. We investigate if screw fixation is necessary when a GB DMD uncemented cup purposefully designed to enhance osseointegration is implanted. The specific objectives of this project are to i) evaluate the migration profile of the GB DMD uncemented acetabular Cup at 3 months, 1 and 2 years ii) compare quality of stability (using radiostereometric analysis) and clinical outcomes with screw verses no screw fixation at 2 years
Interventions
Screw fixation of a press fit uncemented cup by one of 2 experienced orthopaedic surgeons (> 15 years) at a single private hospital. This intervention will be delivered once at time of primary hip arthroplasty. This surgery generally takes 60-90 minutes to perform.
Sponsors
Gruppo Bioimpianti Srl
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. consenting male and female patients 2. aged 50 to 75-years 3. degenerative native hip-joint pathology 4. adequate acetabular and femoral bone stock for uncemented fixation
Exclusion criteria
1. local hip joint infection or significant systemic disease 2. affected by neuromuscular or sensory pathology 3. immunosuppressed 4. morbidly obese (BMI higher than 40) 5. unable to comply with the postoperative follow-up investigations to be inducted into the study
Outcome results
None listed