Avenir® Cemented Hip Stem - PMCF

Launched by ZIMMER BIOMET · Jan 4, 2018

Keywords

ClinConnect Summary

The Avenir® Cemented Hip Stem study is looking at how safe and effective a specific type of hip implant is for people undergoing total hip replacement surgery. This trial is for adults aged 18 and older who are experiencing severe hip pain and disability that makes surgery necessary. To participate, patients need to be willing to follow post-surgery therapy and attend follow-up appointments, as these are important for the study.

While the trial is currently active and not recruiting new participants, it's important to know that people with certain health issues, such as severe infections, significant muscle or nerve problems, or allergies to metal, may not be eligible. If selected, patients can expect to have their safety and recovery monitored closely after receiving the implant, helping researchers gather valuable information about its performance in real-life settings. Overall, this study aims to ensure that the Avenir® Cemented Hip Stem provides good outcomes for those needing hip surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient is 18 years of age minimum.
• • Patient is suffering from severe hip pain and disability requiring primary unilateral or bilateral total hip arthroplasty based on physical exam and medical history.
• • Patient is willing and able to cooperate in the required post-operative therapy.
• • Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
• Exclusion Criteria:
• • Patient is unwilling or unable to give consent, or to comply with the follow-up program.
• • Acute, chronic, local, or systemic infections.
• • Severe muscular, neural, or vascular diseases that endanger the limbs involved.
• • Lack of bony structures proximal or distal to the joint, so that good anchorage of the implant is unlikely or impossible.
• • Total or partial absence of the muscular or ligamentous apparatus.
• • Any concomitant diseases that can jeopardize the functioning and the success of the implant.
• • Allergy to the implanted material, especially to metal (e.g., stainless steel).
• • Local bone tumors and/or cysts.
• • Pregnancy
• • Skeletal immaturity
• • Patients who have any condition that would in the judgment of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, a known drug abuser or alcoholic or anyone who cannot understand what is required of them.
• • Patients with plans to relocate during the study follow-up period.
• • For patients biologically younger than 60 years with joint disease, a different reconstruction operation (e.g., osteotomy) or arthrodesis may be indicated.