Back to results

Affixus Natural Nail System Humeral Nail PMCF

Primary Purpose

Humeral Fractures, Proximal, Humeral Fractures

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Affixus Natural Nail System

About this trial

This is an interventional treatment trial for Humeral Fractures, Proximal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion 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.

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 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.

Sites / Locations

Cleveland Clinic Florida
University of Texas Health Science Center at San Antonio
UZ Leuven - Traumatology DepartmentRecruiting
Hospital de la Santa Creu i Sant PauRecruiting
Kantonsspital FrauenfeldRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

Subject target population suffers from fractures or osteotomies of the humerus which require temporary fixation and stabilization.

Outcomes

Primary Outcome Measures

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.)

Secondary Outcome Measures

Range of Motion

The Range of Motion (total shoulder motion, active and passive) of the affected and contralateral (right and left) upper arm will be measured.

EQ-5D-5L

EQ-5D-5L Health Questionnaire is completed by the patient and assesses his/her general health status. The EQ-5D-5L is used to derive a quality of life index used for health economics considerations.

Radiographic Findings

Postoperative Radiographic Evaluation collects radiographic parameters like bridging callus, visible fracture line, device fracture, device loosening and union status (AP, lateral, and auxiliary view).

Adverse Events

Adverse Event Report is completed as needed for each complication which is noted.

Full Information

NCT ID

NCT05019664

First Posted

July 6, 2021

Last Updated

August 16, 2023

Sponsor

Zimmer Biomet

1. Study Identification

Unique Protocol Identification Number

NCT05019664

Brief Title

Affixus Natural Nail System Humeral Nail PMCF

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)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 29, 2022 (Actual)

Primary Completion Date

August 2027 (Anticipated)

Study Completion Date

August 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zimmer Biomet

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Humeral Fractures, Proximal, Humeral Fractures

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment Group

Arm Type

Experimental

Arm Description

Subject target population suffers from fractures or osteotomies of the humerus which require temporary fixation and stabilization.

Intervention Type

Device

Intervention Name(s)

Affixus Natural Nail System

Intervention Description

Intramedullary nailing designed for fixation and stabilization of fractures or osteotomies of the humerus. Nails are comprised of proximal and antegrade/retrograde.

Primary Outcome Measure Information:

Title

Bone Union

Description

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.)

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Range of Motion

Description

The Range of Motion (total shoulder motion, active and passive) of the affected and contralateral (right and left) upper arm will be measured.

Time Frame

12 months

Title

EQ-5D-5L

Description

EQ-5D-5L Health Questionnaire is completed by the patient and assesses his/her general health status. The EQ-5D-5L is used to derive a quality of life index used for health economics considerations.

Time Frame

12 months

Title

Radiographic Findings

Description

Time Frame

12 months

Title

Adverse Events

Description

Adverse Event Report is completed as needed for each complication which is noted.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion 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. 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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kristopher J Krajewski, B.A.

Phone

+41 79 396 94 59

Kristopher.Krajewski@zimmerbiomet.com

First Name & Middle Initial & Last Name or Official Title & Degree

Darin A Fawley, B.S., M.A

Phone

+1 574 373 4340

Darin.Fawley@zimmerbiomet.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hassan Achakri, Ph.D.

Organizational Affiliation

Director Clinical Affairs

Official's Role

Study Director

Facility Information:

Facility Name

Cleveland Clinic Florida

City

Weston

State/Province

Florida

ZIP/Postal Code

33331

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jorge Manrique-Succar, M.D.

Phone

954-659-5000

jorgemanriquemd@gmail.com

Facility Name

University of Texas Health Science Center at San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anil K. Dutta, M.D.

Phone

210-882-9983

duttaa@uthscsa.edu

Facility Name

UZ Leuven - Traumatology Department

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Harm Hoekstra, M.D.

Phone

+ 32 16 34 13 27

harm.hoekstra@uzleuven.be

First Name & Middle Initial & Last Name & Degree

Elga Nijs

Phone

+32 16 34 23 64

elga.nijs@uzleuven.be

Facility Name

Hospital de la Santa Creu i Sant Pau

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Julio de Caso, M.D.

Phone

+34 617715500

jcaso@santpau.cat

Facility Name

Kantonsspital Frauenfeld

City

Frauenfeld

State/Province

Thurgau

ZIP/Postal Code

8501

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Florian Hess, M.D.

Phone

+41 52 723 76 81

florian.hess@stgag.ch

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

This aspect of the study is undecided.

Learn more about this trial

Affixus Natural Nail System Humeral Nail PMCF

We'll reach out to this number within 24 hrs