Recruiting

ALPS Plating System

Sponsor:

Vanderbilt University Medical Center

Code:

NCT03328650

Conditions

Proximal Humeral Fracture

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Conditions

Proximal Humeral Fracture

Study ID

NCT03328650

Start date

Aug 7, 2017

Status verified date

May, 2026

Completion date

Dec 1, 2031

Anticipated

Primary completion date

Dec 1, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Bone Material Strength [ Time Frame: During surgical procedure ]
  • Bone Indentation Distance [ Time Frame: During surgical procedure ]

Central Contacts and Locations

Central contacts

Julie M Daniels

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

Locations

Vanderbilt Orthopaedics

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Julie M Daniels

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

Principal Investigator:

Mihir J Desai, MD

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

May 11, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-05-11.