Global, Multicenter, and Prospective Post-Market Clinical Follow-Up Study of the Avenir Complete™ Femoral Stem (Implants and Instrumentation)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Hip
- Sponsor
- Zimmer Biomet
- Enrollment
- 275
- Locations
- 9
- Primary Endpoint
- Survival of the study device; whether or not it is still implanted in the subject
- Status
- Active, Not Recruiting
- Last Updated
- 10 months ago
Overview
Brief 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.
Detailed Description
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: The primary endpoint is defined by the survival of the implant system at 10 years, which is based on the removal or intended removal of the "study device and determined using Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. The secondary endpoints are the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs) as well as radiographic outcomes (if available).
Investigators
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Survival of the study device; whether or not it is still implanted in the subject
Time Frame: 10 years
Survival is classified as removal of the study device for any reason
Secondary Outcomes
- Radiographic analysis(10 years)
- Oxford Hip Score(10 years)
- Patient Quality of Life(10 years)
- Incidence of treatment-emergent Adverse Events (safety)(10 years)
- Harris Hip Score(3 years)