RecruitingNot Applicable

Clinical Outcomes of the ALPS Proximal Humerus Plating System

United States150 participantsStarted 2017-08-07

Plain-language summary

The purpose of this study is to document the performance and clinical outcomes of the A.L.P.S® Proximal Humerus Plating System. Specific Aims: * Conduct physical assessments measuring shoulder strength and range of motion, physician assessment of radiographs * Obtain patient-reported outcomes regarding pain level, function capabilities, and work/leisure restrictions * Document revisions, complications, and adverse events

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: * Patients who present with a proximal humerus fracture requiring primary or revision ORIF using A.L.P.S Proximal Humerus Plating System * Patients who present with a proximal humerus fracture that involves the metaphysis * 18 years or older Exclusion Criteria: * Patients under the age of 18 * Patients who have an infection, sepsis, or osteomyelitis * Patients who are unwilling to take part in study, have documented psychiatric disorder that limits ability to consent and maintain follow-up, or who may have severe problems maintaining follow-up (e.g. patients who are prisoners, homeless, intellectually changed without adequate family support) * Patients who do not speak English (do to unavailability of non-English surveys) * Patients who have known risk factors of pathologic fractures (e.g. bone metastasis) * Patients who have received treatment for osteoporosis (e.g. bisphosphonate) within the last 5 years or whose treatment lasted longer than 5 years * Patients who have Type 1 diabetes * Patients who have other bone disease (e.g. osteogenesis imperfecta, Paget's disease, thyroid disease, Vitamin D deficiency, hyperparathyroidism) * Patients that have a history of cancer, abnormal serum calcium, or chronic steroid use

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

Bone Material Strength

Timeframe: During surgical procedure

Bone Indentation Distance

Timeframe: During surgical procedure

Trial details

NCT IDNCT03328650

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2031-12-01

Contact for this trial

Julie M Daniels

615-322-4506 Julie.M.Daniels@Vanderbilt.edu

View on ClinicalTrials.gov More Proximal Humeral Fracture trials