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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.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000193370
Enrollment
30
Registered
2008-04-11
Start date
2008-07-14
Completion date
2010-11-05
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 wh

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.

Sponsors

Stryker South Pacific
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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 criteria

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026