Clinical trial NCT03328650: Clinical Outcomes of the ALPS Proximal Humerus Plating System
Official title: Clinical Outcomes of the ALPS Proximal Humerus Plating System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Proximal Humeral Fracture
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have suffered a proximal humerus fracture that requires operative intervention using the A.L.P.S Proximal Humerus Plating System.

Brief 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

Detailed 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

Eligibility 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

Primary outcomes:
measure: Bone Material Strength
timeFrame: During surgical procedure
measure: Bone Indentation Distance
timeFrame: During surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Orthopaedics
state: Tennessee
Study officials:
References: