Avenir Complete Post-Market Clinical Follow-Up Study

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.

Conditions

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

Study Overview

Study Details

Study overview

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.

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

Avenir Complete Post-Market Clinical Follow-Up Study

Condition
Osteoarthritis, Hip
Intervention / Treatment

-

Contacts and Locations

Jackson

Mississippi Sports Medicine and Orthopaedic Center PLLC, Jackson, Mississippi, United States, 39202

Saint Joseph

Heartland Regional Medical Center d.b.a. Mosaic Life Care, Saint Joseph, Missouri, United States, 64506

Portland

Orthopedic & Fracture Clinic, PC, Portland, Oregon, United States, 97225

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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;

Ages Eligible for Study

20 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Zimmer Biomet,

Study Record Dates

2036-06-01