Clinical Outcomes of the ALPS Proximal Humerus Plating Sy... | NCT03328650

Studies
Clinical Outcomes of the ALPS Proximal Humerus Plating System

NCT03328650

Sponsor

Vanderbilt University Medical Center

Status

Recruiting

Last Update Posted

May 11, 2026Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Proximal Humeral Fracture

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 7, 2017Actual

Primary Completion Date

Dec 1, 2031Estimated

Completion Date

Dec 1, 2031Estimated

First Submitted Date

Oct 9, 2017

First Submission Date that Met QC Criteria

Oct 27, 2017

First Posted Date

Nov 1, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2026

Last Update Posted Date

May 11, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bone Material Strength	Measured by the Osteoprobe	During surgical procedure
Bone Indentation Distance	Measured by the Osteoprobe	During surgical procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Julie M Daniels	Contact	615-322-4506		Julie.M.Daniels@Vanderbilt.edu

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt Orthopaedics	Recruiting	Nashville	Tennessee	37232	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

No plan to make individual participant data available to other researchers.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries
D000070599	Shoulder Injuries