Avenir® Cemented Hip Stem - PMCF

Zimmer Biomet

Status: Active, not recruiting

Conditions: Femoral Head Necrosis; Femoral Neck Fractures; Post-Traumatic Osteoarthritis of Hip; Congenital Hip Dysplasia; Osteotomies; Sequelae From Previous Hip Surgery; Primary Osteoarthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT03396224

CME2013-03H

Details and patient eligibility

About

The objective of this post-market clinical follow-up study is to confirm the safety and performance of the Avenir® Cemented Hip stem when used in primary total hip arthroplasty.

Full description

This is a multicenter, prospective, non-controlled post-market clinical follow-up study to fulfill the post market surveillance obligations according to Medical Device Directive and MEDDEV 2.12-2.

The objectives of this study are to confirm the safety and performance of the Avenir Cemented Hip Stem when used in primary total hip arthroplasty at 6 weeks to 6 months, 1, 2, 3, 5, 7 and 10 years post-operatively.

The Avenir Cemented Hip Stem is a straight double-tapered stem offering 9 standard and 9 lateralized versions, the same as the uncemented version, the Avenir-Mueller Stem.

Safety will be evaluated by monitoring the frequency and incidence of adverse events and through radiographic review.

Performance will be based on the implant survival, overall pain and functional performances, subject quality-of-life and radiographic parameters of study subjects who received the Avenir® Cemented Hip stem.

Implant survival will be based on removal or intended removal of the device.

A total of 130 patients will be enrolled into the study at up to 4 sites.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Patients who received the Avenir® Cemented Hip Stem

Description:

Patients suffering from severe hip pain and disability requiring total hip arthroplasty and who meet the inclusion/exclusion criteria