ACTIVE_NOT_RECRUITING

Avenir Complete Post-Market Clinical Follow-Up Study

Conditions

Osteoarthritis, Hip Avascular Necrosis of Hip Avascular Necrosis of the Femoral Head Post-traumatic; Arthrosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-09-27

Study Completion:2036-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04731077

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:20 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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;	* 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; * 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;

Inclusion Criteria

Exclusion 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;

* 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;
* 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;

Contacts and Locations

Study Locations (Sites)

Mississippi Sports Medicine and Orthopaedic Center PLLC

Jackson, Mississippi, 39202

United States

Heartland Regional Medical Center d.b.a. Mosaic Life Care

Saint Joseph, Missouri, 64506

United States

Orthopedic & Fracture Clinic, PC

Portland, Oregon, 97225

United States

Collaborators and Investigators

Sponsor: Zimmer Biomet

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-27

Study Completion Date2036-06-01

Study Record Updates

Study Start Date2021-09-27

Study Completion Date2036-06-01

Terms related to this study

Additional Relevant MeSH Terms

Osteoarthritis, Hip
Avascular Necrosis of Hip
Avascular Necrosis of the Femoral Head
Post-traumatic; Arthrosis