ClinicalTrials.gg
RecruitingNCT03328650ALPS PHPUpdated May 11, 2026

Clinical Outcomes of the ALPS Proximal Humerus Plating System

An observational study in Proximal Humeral Fracture, sponsored by Vanderbilt University Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-11.

Sponsored by Vanderbilt University Medical Center · Observational

From the registry’s dates

  • Started Aug 2017; still recruiting 9 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 21 studies in Shoulder Fractures with a site in United States — 10 open to participants now, 13 under way, none of them phase 3. Shoulder Fractures · United States.

Planned enrollment
5th of 17
150 · median 100
Started
2017
with 2 others
Observational
17 of 21
9 open now
Primary completion
2031-12
later than 5 of 12 live
Registered
4th of 21
by date
Lead sponsor
1 of 21
Vanderbilt University Medical Center

Among the 21 studies in Shoulder Fractures with a site in United States, this one is the 5th largest by planned enrollment of the 17 observational ones that give a count, is one of 3 that started in 2017, is one of 17 observational ones, reaches primary completion later than 5 of the 12 other live ones, and was the 4th registered.

Shoulder Fractures

113 studies on the registry are indexed under Shoulder Fractures; 30 are open to participants now.

Browse Shoulder Fractures studies →

Open to participants now

10 of the 21 studies in Shoulder Fractures with a site in United States are open now. Recruiting first, the newest first:

4 more — sign in →

All 10 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 18 Shoulder Fractures studies recruiting now, 13 (72%) set no upper age limit and 3 (17%) stop at 75 or younger; 4 take children under 18; 2 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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
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
03

Conditions studied

  • Proximal Humeral Fracture

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 )
  • 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 use
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Bone Material Strength

    Measured by the Osteoprobe

    Time frame: During surgical procedure

  2. Bone Indentation Distance

    Measured by the Osteoprobe

    Time frame: During surgical procedure

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — No plan to make individual participant data available to other researchers.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2017 (actual). Primary completion is estimated for Dec 2031, 171 months after the start.

Of 30 observational studies under Shoulder Fractures, half reached primary completion within 83 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 109. This study's planned 171 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 9, 2017
First posted
Nov 1, 2017
StartActual
Aug 7, 2017
Primary completionEst.
Dec 1, 2031
CompletionEst.
Dec 1, 2031
Last update
May 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03328650
Responsible party
Mihir Desai (Assistant Professor of Orthopaedic Surgery and Rehabilitation, Vanderbilt University Medical Center) — Principal investigator
First posted
Nov 1, 2017
Start date
Aug 7, 2017
Primary completion
Dec 1, 2031 (estimated)
Completion
Dec 1, 2031 (estimated)
Last update
May 11, 2026

Study contacts

Julie M Daniels
Contact
Julie.M.Daniels@Vanderbilt.edu
615-322-4506

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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