Clinical Outcomes of the ALPS Proximal Humerus Plating System (ALPS PHP)

Vanderbilt University Medical Center

Status: Enrolling

Conditions: Proximal Humeral Fracture

Study type: Observational

Funder types: Other

Identifiers

NCT03328650

171043

Details and patient eligibility

About

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

Full description

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 1 patient group

Proximal Humerus Fracture Patients

Description:

As part of their routine care, patients who have experienced a proximal humerus fracture that requires operative fixation will receive the A.L.P.S® Proximal Humerus Plating System. This study is an observational, prospective study that monitors the patient's pain, functional ability, and patient-reported outcomes.