Clinical Outcomes of the ALPS Proximal Humerus Plating System

Proximal Humeral Fracture Clinical Trial

— ALPS PHP  

Official title:

Clinical Outcomes of the ALPS Proximal Humerus Plating System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03328650
• Other study ID #: 171043
• Status: Recruiting
• Start date: August 7, 2017
• Est. completion date: December 1, 2031

Study information

• Verified date: March 2024
• Source: Vanderbilt University Medical Center
• Contact: Julie M Daniels
• Phone: 615-322-4506
• Email: Julie.M.Daniels[@]Vanderbilt.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 1, 2031
• Est. primary completion date: December 1, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Humeral Fractures
• Proximal Humeral Fracture
• Shoulder Fractures

Locations

Country	Name	City	State
United States	Vanderbilt Orthopaedics	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Material Strength	Measured by the Osteoprobe	During surgical procedure
Primary	Bone Indentation Distance	Measured by the Osteoprobe	During surgical procedure