None listed
Conditions
Brief summary
The purpose of this clinical study is to determine the predicted long-term safety and effectiveness of the anthology cementless femoral stem using an RSA technique to yield early results in small numbers of patients. The secondary purpose of this study is to assess the efficacy of fully coating this stem with hydroxyapatite (HA) compared to a proximally-HA coated stem.
Interventions
prospective controlled trial comparing partially coated cementless stem to fully hydroxyapatite (HA) coated cementless stem.
cementless stems utilise a fixation surface to optimise the fixation to bone. In this design the proximal end of the stem has a macro texture with a titanium coating. Hydroxyapatite is applied to the proximal coating or the full length of the stem to enhance initial fixation.
Patients enrolled in this study will have their surgery during a 12 month
recruitment period.
prospective controlled trial comparing partially coated cementless stem to fully hydroxyapatite (HA) coated cementless stem. cementless stems utilise a fixation surface to optimise the fixation to bone. In this design the proximal end of the stem has a macro texture with a titanium coating. Hydroxyapatite is applied to the proximal coating or the full length of the stem to enhance initial fixation. Patients enrolled in this study will have their surgery during a 12 month recruitment period. The operation takes approximately 1 hour. Patients will be studied for two years following their surgery and will return for routine follow-up thereafter.
Sponsors
David Campbell
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
hip osteoarthritis
Exclusion criteria
non-osteoarthritis hip disease
Outcome results
None listed