NCT05019664

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
15mo left

Started Aug 2022

Longer than P75 for all trials

Geographic Reach
4 countries

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Aug 2022Aug 2027

First Submitted

Initial submission to the registry

July 6, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
1 year until next milestone

Study Start

First participant enrolled

August 29, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

November 12, 2025

Status Verified

June 1, 2025

Enrollment Period

4.9 years

First QC Date

July 6, 2021

Last Update Submit

November 10, 2025

Conditions

Humeral Fractures, ProximalHumeral Fractures

Outcome Measures

Primary Outcomes (1)

  • Bone Union

    The primary endpoint is bone union after 12 months since surgery. (Bone union defined as no pain or tenderness at the site, and strong enough to allow normal activities.)

    12 months

Secondary Outcomes (4)

  • Range of Motion

    12 months

  • EQ-5D-5L

    12 months

  • Radiographic Findings

    12 months

  • Adverse Events

    12 months

Interventions

humeral fractureDEVICE

Patient with either a proximal humeral fracture or humeral shaft fracture requiring surgical intervention and be eligible for fixation by intramedullary nailing.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive series of 100 subjects globally implanted with the Affixus Natural Nail System Humeral Nail for temporary fixation and stabilization of fractures or osteotomies of the humerus.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

UZ Leuven - Traumatology Department

Leuven, 3000, Belgium

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

RECRUITING

General Foundation of the University of Valladolid

Valladolid, 47002, Spain

RECRUITING

Kantonsspital Frauenfeld

Frauenfeld, Thurgau, 8501, Switzerland

RECRUITING

MeSH Terms

Conditions

Shoulder FracturesHumeral Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesShoulder InjuriesArm Injuries

Study Officials

  • Emilie Rohmer, MSc.

    Zimmer Biomet

    STUDY DIRECTOR

Central Study Contacts

Kristopher Krajewski, B.A.

CONTACT

+41 79 396 94 59kristopher.krajewski@zimmerbiomet.com

Richard J Marek, B.A.

CONTACT

+1 574 453 7567richard.marek@zimmerbiomet.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2021

First Posted

August 25, 2021

Study Start

August 29, 2022

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

November 12, 2025

Record last verified: 2025-06

Locations

CH(1)US(1)ES(2)BE(1)