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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
Must not have
Bone shaft having excessive bow or deformity
Distal fracture involving the olecranon fossa
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

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.
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.
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
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I am 18 years or older and my bones have stopped growing.
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I need surgery for a broken upper arm and can have a rod placed inside the bone.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My bone is abnormally curved or deformed.
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I have a fracture near my elbow.
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My bone's central cavity was filled due to a past fracture or tumor.
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I am able to understand and follow the study's requirements.
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My bones are still growing.
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I have had or currently have an infection.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Bone Union
Secondary study objectives
Adverse Events
EQ-5D-5L
Radiographic Findings
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

Zimmer BiometLead Sponsor
378 Previous Clinical Trials
67,983 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
~53 spots leftby Aug 2027
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