Prospective consecutive series, assessing Chrome and Cobalt metal ions in patients after hip resurfacing surgery.
Prospective consecutive series of 40 patients undergoing metal on metal hip resurfacing surgery, assessing the change in metal ions over time.
Stryker South Pacific
40 participants
Jul 14, 2008
Interventional
Conditions
Eligibility
Inclusion Criteria1
- MITCH hip resurfacing group: * Diagnosed with degenerative osteoarthritis * Good femoral bone stock * Good acetabular bone quality * Templated for size 48-56 femoral head * Minimal femoral bone deformity: <1/3 of the femoral head with cysts * Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow up * patients who are capable of, and have given, informed consent to their participation in the study MITCH modular head hip arthrosplasty group: * diagnosed with degenerative osteoarthritis or avascular necrosis * Good acetabular bone quality * Templated for a size 56 acetabulum and 46-54 femoral head * Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow up * Patients who are capable of, and have given informed consent to their participation in the study
Exclusion Criteria12
- MITCH hip resurfacing group:
- Patients with renal impairment
- Patients with primary avascular necrosis
- Patients that have any other metallic implants
- Patients that may be taking health supplements with Chrome or Cobalt
- Patients with osteoporosis
- metabolic disorders that may affect chromium and cobalt metabolism
- MITCH modular head hip arthroplasty group:
- patients with renal impairment
- patients that have any other metallic implants
- patients that may be taking health supplements with Chrome or Cobalt
- metabolic disorders that may affect Chromium and Cobalt metabolism
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
This study includes 2 types of interventions. Group one will undergo hip resurfacing surgery using the Stryker 'MITCH' resurfacing system. The 'MITCH' resurfacing system is in 2 parts - an acetabular cup, and a femoral cap which sits over the femoral head. Group two will undergo surgery using the Stryker 'MITCH' modular system with a Stryker 'Accolade' stem. The 'MITCH' modular system is in 3 parts - an acetabular cup, a femoral component which replaces the femoral head and an 'Accolade' stem which sits in the femur and supports the whole construct. Surgery for group one and group two will take approximately 2 hours. Both groups will be followed for 2 years.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12608000193370