A Multi-Centre, Prospective Study to Obtain Survival and Clinical Outcome Data on the Zimmer Hip Resurfacing System Utilising the Metasul Monoblock Component™ Cup in a Hip Resurfacing Application With the Durom® Hip Resurfacing Femoral Component.
The Zimmer Hip Resurfacing System Post-Market Clinical Follow-up study will examine the safety and efficacy of this device in the young and/or active patient with advanced hip disease.
• Patient selection without bias to race or gender.
• Patient is ≥ 18 and ≤ 65 years of age.
• Female patients only, if
‣ Actively practicing a contraceptive method, or
⁃ Surgically sterilized, or
⁃ Post-menopausal
• Pre-operative Harris Hip Score ≤ 70.
• Primary surgical hip candidate, suffering from hip pain and/or disability due to degenerative joint disease (inflammatory or non-inflammatory), based on physical examination and history, which may include the following diagnosis:
‣ Non-inflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis or osteoarthritis
⁃ Inflammatory joint disease (IJD), e.g., rheumatoid arthritis
• Patient is willing and able to cooperate in prescribed post-operative therapy.
• Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
• Patient has participated in the Informed Consent process and has signed an Ethics Committee approved Informed Consent.