Affixus Natural Nail System Humeral Nail PMCF

Last updated: April 5, 2024
Sponsor: Zimmer Biomet
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Affixus Natural Nail System

Clinical Study ID

NCT05019664
CMG2020-09T
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients 18 years or older and skeletally mature.
  • Patient must have either a proximal humeral fracture or humeral shaft fracturerequiring surgical intervention and be eligible for fixation by intramedullarynailing.
  • Patient has been or is scheduled to be treated with the Affixus Natural Nail SystemHumeral Nail.
  • Patient must be able and willing to complete the protocol required follow-up.
  • Patient must have a signed Institutional Review Board/Ethics Committee approvedinformed consent. (An Institutional Review Board/Ethics Committee is group that hasbeen formally designated to review and monitor medical research involving humansubjects.)
  • Patients capable of understanding the surgeon's explanations and following hisinstructions, able and willing to participate in the follow-up program and who gaveconsent to take part in the study.

Exclusion

Exclusion Criteria:

  • 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 theimplant.
  • Patients with mental or neurologic conditions who are unwilling or incapable of givingproper informed consent and following postoperative care instructions.
  • Patient is a vulnerable subject (prisoner, mentally incompetent or unable tounderstand 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 fixedaddress, long distance, plans to move during course of study).
  • Patients who have any condition that would in the judgment of the investigator placethe patient at undue risk or interfere with the study.
  • Not expected to survive the duration of the follow-up program.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Affixus Natural Nail System
Phase:
Study Start date:
August 29, 2022
Estimated Completion Date:
August 31, 2027

Study Description

Study objective:

The objectives of this observational, prospective study with optional retrospective enrollment are to confirm safety, performance and clinical benefits of the Affixus Natural Nail System Humeral Nail and its instrumentation by analyzing adverse event records, fracture/osteotomy healing and functional outcome and adverse events.

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 performance and clinical benefits will be evaluated by assessment of fracture/osteotomy healing and functional outcome of all enrolled study subjects.

Study Endpoints:

Primary endpoint:

The primary endpoint is bone union after 12 months since surgery.

Secondary endpoint:

The secondary endpoints will be evaluating functional outcomes (Range of Motion, & American Shoulder and Elbow Surgeons questionnaire), quality of life questionnaire (EQ-5D-5L), radiographic findings and adverse events including re-operation of all enrolled study subjects at the defined follow up time points.

Connect with a study center

  • UZ Leuven - Traumatology Department

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025
    Spain

    Active - Recruiting

  • Kantonsspital Frauenfeld

    Frauenfeld, Thurgau 8501
    Switzerland

    Active - Recruiting

  • Cleveland Clinic Florida

    Weston, Florida 33331
    United States

    Site Not Available

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas 78229
    United States

    Active - Recruiting

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