RECRUITING

Affixus Natural Nail System Humeral Nail PMCF

Conditions

Humeral Fractures, Proximal Humeral Fractures

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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

A commercially available product clinical study which aims to confirm the safety, performance and clinical benefits to the patient of the Affixus Natural Nail upper arm (humerus) bone nail system for both the implant itself and the instrumentation used during surgery.

Official Title

Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Affixus Natural Nail System Humeral Nail (Implants and Instrumentation)

Quick Facts

Study Start:2022-08-29

Study Completion:2027-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05019664

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:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients 18 years or older and skeletally mature. * Patient must have either a proximal humeral fracture or humeral shaft fracture requiring surgical intervention and be eligible for fixation by intramedullary nailing. * Patient has been or is scheduled to be treated with the Affixus Natural Nail System Humeral Nail. * Patient must be able and willing to complete the protocol required follow-up. * Patient must have a signed Institutional Review Board/Ethics Committee approved informed consent. (An Institutional Review Board/Ethics Committee is group that has been formally designated to review and monitor medical research involving human subjects.) * 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.	* Distal fracture involving the olecranon fossa. * Bone shaft having excessive bow or deformity. * A medullary canal obliterated by a previous fracture or tumor. * Active or previous infection. * Skeletally immature patients. * All concomitant diseases that can impair the functioning and the success of the implant. * Patients with mental or neurologic conditions who are unwilling or incapable of giving proper informed consent and following postoperative care instructions. * Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant). * Patient known to be pregnant or breast feeding. * Likely problems with maintaining follow-up program (e.g. patient with no fixed address, long distance, plans to move during course of study). * Patients who have any condition that would in the judgment of the investigator place the patient at undue risk or interfere with the study. * Not expected to survive the duration of the follow-up program.

Inclusion Criteria

Exclusion Criteria

* Patients 18 years or older and skeletally mature.
* Patient must have either a proximal humeral fracture or humeral shaft fracture requiring surgical intervention and be eligible for fixation by intramedullary nailing.
* Patient has been or is scheduled to be treated with the Affixus Natural Nail System Humeral Nail.
* Patient must be able and willing to complete the protocol required follow-up.
* Patient must have a signed Institutional Review Board/Ethics Committee approved informed consent. (An Institutional Review Board/Ethics Committee is group that has been formally designated to review and monitor medical research involving human subjects.)
* 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.

* Distal fracture involving the olecranon fossa.
* Bone shaft having excessive bow or deformity.
* A medullary canal obliterated by a previous fracture or tumor.
* Active or previous infection.
* Skeletally immature patients.
* All concomitant diseases that can impair the functioning and the success of the implant.
* Patients with mental or neurologic conditions who are unwilling or incapable of giving proper informed consent and following postoperative care instructions.
* Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant).
* Patient known to be pregnant or breast feeding.
* Likely problems with maintaining follow-up program (e.g. patient with no fixed address, long distance, plans to move during course of study).
* Patients who have any condition that would in the judgment of the investigator place the patient at undue risk or interfere with the study.
* Not expected to survive the duration of the follow-up program.

Contacts and Locations

Study Contact

Priscila Guedes, B.S.

CONTACT

+41 79 891 14 25

priscila.guedes@zimmerbiomet.com

Richard J Marek, B.A.

CONTACT

+1 574 453 7567

richard.marek@zimmerbiomet.com

Principal Investigator

Hassan Achakri, Ph.D.

STUDY_DIRECTOR

Director Clinical Affairs

Study Locations (Sites)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: Zimmer Biomet

Hassan Achakri, Ph.D., STUDY_DIRECTOR, Director Clinical Affairs

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 Date2022-08-29

Study Completion Date2027-08

Study Record Updates

Study Start Date2022-08-29

Study Completion Date2027-08

Terms related to this study

Additional Relevant MeSH Terms

Humeral Fractures, Proximal
Humeral Fractures