Active, not recruiting
Not applicable
Avenir Complete Post-Market Clinical Follow-Up Study
Condition(s) studied
Osteoarthritis, HipAvascular Necrosis of HipAvascular Necrosis of the Femoral HeadPost-traumatic; Arthrosis
Investigational drug(s) / intervention(s)
Avenir Complete Femoral Stem
Avenir Complete Femoral Stem: All enrolled subjects will receive the Avenir Complete Femoral Stem
Study 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.
Eligibility
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, 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. cobalt, chromium, nickel, etc.);
* Local bone tumors and/or cysts;
* Pregnancy;
* Skeletal immaturity.
* Patients unwilling or unable to give consent, or to comply with the follow-up program;
* Patients who have any condition that would - in the judgement of the Investigator - place him/her at undue risk or
* interfere with the study;
* Any vulnerable subject:
* a prisoner
* mentally incompetent or unable to understand what participation in the study entails
* a known alcohol or drug abuser
* anticipated to be non-compliant
* Patients with plans to relocate during the study follow-up period;
* Individuals whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate;
Primary outcome measure(s)
- Survival of the study device; whether or not it is still implanted in the subject — 10 years
Survival is classified as removal of the study device for any reason
Trial sites (9)
| Facility | City | Region | Status |
| Mississippi Sports Medicine and Orthopaedic Center PLLC |
Jackson |
Mississippi |
|
| Heartland Regional Medical Center d.b.a. Mosaic Life Care |
Saint Joseph |
Missouri |
|
| Orthopedic & Fracture Clinic, PC |
Portland |
Oregon |
|
| Copenhagen University Hospital, Hvidovre |
Copenhagen |
Denmark |
|
| Nissan Tamagawa Hospital |
Setagaya-Ku |
Tokyo |
|
| Okayama City Hospital |
Okayama |
Japan |
|
| Ikazia Ziekenhuis |
Rotterdam |
South Holland |
|
| Sykehuset Innlandet HF |
Tynset |
Norway |
|
| Sahlgrenska University Hospital - Molndal |
Mölndal |
Sweden |
|
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