Proximal Humeral FractureALPS PHPNCT03328650
Clinical Outcomes of the ALPS Proximal Humerus Plating System
An observational study of Proximal Humeral Fracture, run by Vanderbilt University Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proximal Humeral Fracture
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2017to 1 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have suffered a proximal humerus fracture that requires operative intervention using the A.L.P.S Proximal Humerus Plating System.
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt Orthopaedics
Nashville, Tennessee, 37232
Julie M Daniels, 615-322-4506, Julie.M.Daniels@Vanderbilt.edu
Mihir J Desai, MD
About this study
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
Read the 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
- Conditions
- Proximal Humeral Fracture
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Proximal Humerus Fracture Patients | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Material Strength
Measured by the Osteoprobe
Measured: During surgical procedure
Bone Indentation Distance
Measured by the Osteoprobe
Measured: During surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start7 Aug 2017
- Primary completion1 Dec 2031 (estimated)
- Study completion1 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Humeral FractureStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mihir Desai, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328650
- Sponsor's protocol ID
- 171043
- Acronym
- ALPS PHP
- Status last verified
- May 2026
- First submitted
- 9 Oct 2017
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of the ALPS Proximal Humerus Plating System
- ClinicalTrials.gov ID
- NCT03328650
- Acronym / sponsor ID
- ALPS PHP / 171043
- Conditions
- Proximal Humeral Fracture
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 1 Dec 2031 (estimated)
- Study completion
- 1 Dec 2031 (estimated)
- First posted
- 1 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proximal Humerus Fracture Patients | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have suffered a proximal humerus fracture that requires operative intervention using the A.L.P.S Proximal Humerus Plating System.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone Material Strength
Time frame: During surgical procedure
Measured by the Osteoprobe
Bone Indentation Distance
Time frame: During surgical procedure
Measured by the Osteoprobe
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No. No plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proximal Humeral Fracture, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie M Daniels (615-322-4506, Julie.M.Daniels@Vanderbilt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Material Strength (time frame: During surgical procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.