UnknownPhase 4

NovaLign Intramedullary Fixation System (IFS) for the Treatment of Humeral Fractures

United States20 participantsStarted 2009-09

Plain-language summary

This post-market clinical study is being done to evaluate the use of the NovaLign™ Intramedullary Fixation System in the treatment of humeral fractures.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Humeral Fracture * Surgical intervention can be performed within 14 days of injury (injury being Day 0 for this particular criteria) * Fully functioning contralateral limb (e.g., hand, arm, shoulder) * Age 18 years or older and skeletally mature Exclusion Criteria: * Intraarticular fractures or those involving shoulder or elbow of the index arm * Pathologic fracture (e.g., tumor involvement, osteomalacia, etc.; osteoporosis is not an exclusion) * Evidence of neurologic injury in the index arm, including compartment syndrome or radial nerve palsy * Additional upper body injuries (e.g., upper extremity, abdominal, thoracic, neck or head injury) that may affect or inhibit the evaluation of the index or contralateral arm, shoulder, elbow, etc or would not allow the patient to follow or comply with appropriate post-operative regimens * Any previous bodily injury or surgery that may interfere with function or evaluation of index or contralateral arm, shoulder, elbow, etc.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Radiographic union and safety

Timeframe: 12 months

Trial details

NCT IDNCT00969839

SponsorNovaLign Orthopaedics, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-03

View on ClinicalTrials.gov More Fracture trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.