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Orthopedic Implant

Affixus Nail System for Broken Arm

N/A

Recruiting

Research Sponsored by Zimmer Biomet

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial aims to confirm the safety and benefits of the Affixus Natural Nail system for upper arm bone surgery.

Who is the study for?

This trial is for adults over 18 with a broken upper arm bone needing surgery, who can follow the study's procedures and have agreed to participate. It's not for those with certain bone conditions, infections, mental or neurologic issues that prevent consent, pregnancy, or if they're unlikely to complete the study.Check my eligibility

What is being tested?

The Affixus Natural Nail System is being tested in patients with specific types of arm fractures. The study aims to confirm its safety and effectiveness when used in surgical repair of these fractures.See study design

What are the potential side effects?

While specific side effects are not listed here, typical risks may include pain at the site of surgery, infection risk from implants or instruments used during surgery, possible damage to surrounding tissues or nerves.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years or older and my bones have stopped growing.

Select...

I need surgery for a broken upper arm and can have a rod placed inside the bone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Bone Union

Secondary outcome measures

Adverse Events

EQ-5D-5L

Radiographic Findings

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment GroupExperimental Treatment1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Zimmer BiometLead Sponsor

373 Previous Clinical Trials

67,297 Total Patients Enrolled

Hassan Achakri, Ph.D.Study DirectorDirector Clinical Affairs

Media Library

Affixus Natural Nail System (Orthopedic Implant) Clinical Trial Eligibility Overview. Trial Name: NCT05019664 — N/A

Broken Arm Research Study Groups: Treatment Group

Broken Arm Clinical Trial 2023: Affixus Natural Nail System Highlights & Side Effects. Trial Name: NCT05019664 — N/A

Affixus Natural Nail System (Orthopedic Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05019664 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for participants in this experiment?

"Unfortunately, the trial posted on November 15th 2022 is no longer accepting participants. The last update to this study was made on September 22nd 2022; however there are numerous other trials actively recruiting at present with a total of 352 listings."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Affixus Natural Nail System Humeral Nail PMCF

2022. "Affixus Natural Nail System Humeral Nail PMCF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05019664.