Avenir Complete Post-Market Clinical Follow-Up Study
United States, Denmark, Japan275 participantsStarted 2021-09-27
Plain-language summary
The main objectives of this study are to confirm the long-term safety, performance and clinical benefits the Avenir Complete femoral stem and its instrumentation when used in primary total, hemi, and revision hip arthroplasty.
Who can participate
Age range20 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient is at least 20 years old or older and skeletally mature.
* Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases;
* Failed previous hip surgery including
* Joint reconstruction (osteotomy)
* Arthrodesis
* Hemi-arthroplasty or total hip replacement (THR)
* Acute traumatic fracture of the femoral head or neck;
* Avascular necrosis of the femoral head.
* Patients capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study;
Exclusion Criteria:
* 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 Inclusion criteria
* Patient is at least 20 years old or older and skeletally mature.
* Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases;
* Failed previous hip surgery including
* Joint reconstruction (osteotomy)
* Arthrodesis
* Hemi-arthroplasty or total hip replacement (THR)
* Acute traumatic fracture of the femoral head or neck;
* Avascular necrosis of the femoral head.
* Patients capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study;
Exclusion criteria
* Acute, chron…
What they're measuring
1
Survival of the study device; whether or not it is still implanted in the subject