Evaluating the ALPS Proximal Humerus Plating System for shoulder fractures
Clinical Outcomes of the ALPS Proximal Humerus Plating System
Vanderbilt University Medical Center · NCT03328650
This study is testing how well a new shoulder plate works for people with shoulder fractures by looking at their strength, movement, and pain levels after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center (other) |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT03328650 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a proximal humerus fracture requiring surgical intervention using the A.L.P.S Proximal Humerus Plating System.
Not a fit: Patients under 18, those with infections or severe psychiatric disorders, and individuals who do not speak English may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies for proximal humeral fractures, leading to better patient outcomes.
How similar studies have performed: While this study focuses on a specific plating system, similar approaches in evaluating surgical interventions for fractures have shown promising results in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Nashville, Tennessee
- Vanderbilt Orthopaedics — Nashville, Tennessee, United States (RECRUITING)
Study contacts
- Study coordinator: Julie M Daniels
- Email: Julie.M.Daniels@Vanderbilt.edu
- Phone: 615-322-4506
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Proximal Humeral Fracture