Global, Multicenter, and Prospective Post-Market Clinical Follow-Up Study of the Avenir Complete* Femoral Stem (Implants and Instrumentation)

Recruiting

• Conditions: arthritis; worn-out hip; 10023213

• Registration Number: NL-OMON52310
• Lead Sponsor: Zimmer Biomet Nederland bv

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

- Patient is at least 20 years old or older and skeletally mature.

- Patient is 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;

- Patient qualifies for total hip arthroplasty based on physical exam and
medical history including at least one of the following:
o Advanced wear of the joint due to degenerative, post-traumatic or rheumatic
diseases;
o Failed previous hip surgery including:
* joint reconstruction (osteotomy)
* Arthrodesis
* Hemi-arthroplasty or total hip replacement (THR);
o Acute traumatic fracture of the femoral head or neck;
o Avascular necrosis of the femoral head.

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, etc.);

Study & Design

• Study Type: Interventional
• Study Design: Not specified