Clinical Outcomes of the ALPS Proximal Humerus Plating System
ConditionProximal Humeral Fracture
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
Patients who have suffered a proximal humerus fracture that requires operative intervention using the A.L.P.S Proximal Humerus Plating System.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 1 trial groupGroup A: Proximal Humerus Fracture Patients
Trial outcomes
Primary outcomes
1
Bone Material Strength
Measured by the Osteoprobe
Time frame
During surgical procedure2
Bone Indentation Distance
Measured by the Osteoprobe
Time frame
During surgical procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov