Humeral Fractures, ProximalNCT05019664
Affixus Natural Nail System Humeral Nail PMCF
An observational study of Humeral Fractures, Proximal and Humeral Fractures, run by Zimmer Biomet at 5 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Humeral Fractures, Proximal, Humeral Fractures
- What is being tested?
- humeral fracture
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 29 Aug 2022to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Spain2 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
General Foundation of the University of Valladolid
Valladolid, Valladolid, 47002
United States1 site
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
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)
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.
Read the 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.
- Conditions
- Humeral Fractures, Proximal, Humeral Fractures
- Being tested
- humeral fracture
- Medical subject headings
- Shoulder Fractures, Humeral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
humeral fractureDevice
Patient with either a proximal humeral fracture or humeral shaft fracture requiring surgical intervention and be eligible for fixation by intramedullary nailing.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 12 months
Secondary outcomes (4)
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.
Measured: 12 months
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.
Measured: 12 months
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).
Measured: 12 months
Adverse Events
Adverse Event Report is completed as needed for each complication which is noted.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start29 Aug 2022
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humeral Fractures, ProximalStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emilie Rohmer, MSc., Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019664
- Sponsor's protocol ID
- CMG2020-09T
- Status last verified
- Jun 2026
- First submitted
- 6 Jul 2021
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: This aspect of the study is undecided.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05019664
- Acronym / sponsor ID
- CMG2020-09T
- Conditions
- Humeral Fractures, Proximal, Humeral Fractures
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2022 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.)
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| humeral fracturePatient with either a proximal humeral fracture or humeral shaft fracture requiring surgical intervention and be eligible for fixation by intramedullary nailing. | Device | – |
Primary outcome
Bone Union
Time frame: 12 months
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.)
4 secondary outcomes
Range of Motion
Time frame: 12 months
EQ-5D-5L
Time frame: 12 months
Radiographic Findings
Time frame: 12 months
Adverse Events
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Undecided. This aspect of the study is undecided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilie Rohmer, MSc. study director
Zimmer Biomet
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Humeral Fractures, Proximal and Humeral Fractures, run by Zimmer Biomet at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain, United States, Belgium, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Union (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.