Clinical trial NCT05019664: 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
Overall status: RECRUITING
Phase: NA
Conditions: Humeral Fractures, Proximal
Humeral Fractures
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2021-08-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Bone Union
timeFrame: 12 months
Secondary outcomes:
measure: Range of Motion
timeFrame: 12 months
measure: EQ-5D-5L
timeFrame: 12 months
measure: Radiographic Findings
timeFrame: 12 months
measure: Adverse Events
timeFrame: 12 months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Leuven
country: Belgium
facility: UZ Leuven - Traumatology Department
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Frauenfeld
country: Switzerland
facility: Kantonsspital Frauenfeld
state: Thurgau
Study officials:
affiliation: Director Clinical Affairs
name: Hassan Achakri, Ph.D.
role: STUDY_DIRECTOR
References: