Evaluating the ALPS Proximal Humerus Plating System for shoulder fractures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to document the clinical outcomes and performance of the A.L.P.S® Proximal Humerus Plating System in patients with proximal humeral fractures. It involves physical assessments to measure shoulder strength and range of motion, as well as physician evaluations of radiographs. Additionally, patient-reported outcomes regarding pain levels, functional capabilities, and work or leisure restrictions will be collected. The study will also track any revisions, complications, and adverse events associated with the treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• Vanderbilt Orthopaedics
  Nashville, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Julie M Daniels
• Email: Julie.M.Daniels@Vanderbilt.edu
• Phone: 615-322-4506

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing surgical and non-surgical treatments for shoulder fractures in middle-aged adults

  This study is testing whether surgery or non-surgery works better for helping middle-aged adults with shoulder fractures recover and regain function.

  Recruiting Zealand University Hospital · Køge, Region Sjælland and 1 other locations · NCT06416618

• Comparing immobilization duration after shoulder surgery for fractures

  This study is testing if older patients who have shoulder surgery for fractures recover better with early movement compared to those who wear a sling for four weeks without moving their shoulder.

  Recruiting Cooper Norcross Health · Camden, New Jersey · NCT06133920

• Long-term follow-up of patients with Proximal Humerus Fracture Plates

  This study is tracking patients who have had surgery using a special plate for shoulder fractures to see how well it works and if there are any long-term problems over the next 10 years.

  Recruiting Exactech · New York, New York · NCT05703958

• 3-D classification for proximal humerus fractures

  This project uses CT-based 3-D images to test whether a three-dimensional classification helps doctors categorize displaced proximal humeral fractures in adults.

  Recruiting Hebei Medical University Third Hospital · Shijiazhuang, Hebei · NCT04523415

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.