Avenir Complete Post-Market Clinical Follow-Up Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 20 Years and Over
Gender All
More Inclusion & Exclusion 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; - 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 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;

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04731077
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Zimmer Biomet
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Denmark, Japan, Netherlands, Norway, Sweden, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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

The main objectives of this study are to confirm the long-term safety, performance and clinical benefits the Avenir Completeā„¢ 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).

Arms & Interventions

Arms

Other: Avenir Complete Femoral Stem

All enrolled subjects receive the study implant

Interventions

Device: - Avenir Complete Femoral Stem

All enrolled subjects will receive the Avenir Complete Femoral Stem

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Jackson, Mississippi

Status

Active, not recruiting

Address

Mississippi Sports Medicine and Orthopaedic Center PLLC

Jackson, Mississippi, 39202

Saint Joseph, Missouri

Status

Active, not recruiting

Address

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

Saint Joseph, Missouri, 64506

Orthopedic & Fracture Clinic, PC, Portland, Oregon

Status

Active, not recruiting

Address

Orthopedic & Fracture Clinic, PC

Portland, Oregon, 97225

International Sites

Copenhagen University Hospital, Hvidovre, Copenhagen, Denmark

Status

Active, not recruiting

Address

Copenhagen University Hospital, Hvidovre

Copenhagen, , DK-2650

Nissan Tamagawa Hospital, Setagaya-Ku, Tokyo, Japan

Status

Active, not recruiting

Address

Nissan Tamagawa Hospital

Setagaya-Ku, Tokyo, 410-0302

Okayama City Hospital, Okayama, Japan

Status

Active, not recruiting

Address

Okayama City Hospital

Okayama, , 700-0962

Ikazia Ziekenhuis, Rotterdam, Zuid-Holland, Netherlands

Status

Active, not recruiting

Address

Ikazia Ziekenhuis

Rotterdam, Zuid-Holland, 3083 AN

Sykehuset Innlandet HF, Tynset, Norway

Status

Recruiting

Address

Sykehuset Innlandet HF

Tynset, , 2500

Site Contact

Stein Storeggen, MD, PhD

[email protected]

+31 62 395 6378

Molndal, Sweden

Status

Recruiting

Address

Sahlgrenska University Hospital - Molndal

Molndal, , 43180

Site Contact

Raed Itayem, MD, PhD

[email protected]

+31 62 395 6378