Post-Approval Prospective Study - Conventus CAGE™ PH for Use in Proximal Humerus Fracture Fixation

NCT03489408 | Terminated FDA Device

• 1 other identifier: 5807
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to collect device and procedure experience in everyday clinical practice. The patients are being asked to participate in this study because they are a surgical candidate for the treatment of a broken shoulder and are considering treatment with the PH Cage device.

Conditions

Humeral Fractures, Proximal

Keywords

Proximal humerus fracture fixation; trauma

Outcome Measures

Primary Outcomes (1)

• Primary performance patient assessment

  Constant Murley Score

  Change from Baseline in Constant Murley Score at 2-year post-op

Interventions

Conventus Cage™ PH DEVICE

Proximal humeral fracture fixation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study is a prospective, single arm study of patients who are indicated for and have received an FDA cleared Conventus PH Cage.

You may qualify if:

• Patient must be of at least legal age of consent according to applicable State Law.
• Patient is able to understand and provide written consent.
• Patient is willing and able to cooperate with post-operative instructions, including follow-up examinations and limitations of strenuous activities involving the injured extremity.

You may not qualify if:

• The PH Cage should not be implanted in patients with suspected or known allergies to titanium or nickel.
• Patients with open wound fractures.
• Patients with ipsilateral injures or concomitant operation(s) that will have a material impact on the study. Such injuries/ operations are those that affect general health status or the function of the injured extremity.
• Pregnant patients.
• Patients with current or history of mental illness and/or dementia.
• Patients with current or history of alcoholism and/or chemical substance abuse.
• Patient has a medical condition(s) that precludes cooperation with the rehabilitation regimen.
• Patient has active infection at the operative site or other active systemic infection.
• Patient has a pathologic proximal humerus fracture.
• Patients proximal humerus fracture extends into the diaphysis.
• Patient has associated glenohumeral dislocation.
• Patient has ipsilateral injury or concomitant surgery that will have a material impact on the study, such that the injury/surgery affects the patients' health status or the function of the injured extremity.

Sponsors & Collaborators

• Conventus Orthopaedics, Inc.: lead

Study Sites (5)

Stanford University Hospital

Redwood City, California, 94063, United States

Location

Harbor-UCLA

Torrance, California, 90509, United States

Location

The Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Snug Harbor Orthopedics

Duxbury, Massachusetts, 02332, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

MeSH Terms

Conditions

Shoulder Fractures; Wounds and Injuries

Condition Hierarchy (Ancestors)

Fractures, Bone; Shoulder Injuries

Study Officials

• Carrie Hill

  Conventus Orthopaedics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: April 5, 2018
• Study Start: February 1, 2018
• Primary Completion: February 17, 2020
• Study Completion: February 17, 2020
• Last Updated: February 20, 2020

Record last verified: 2020-01

Locations

US (5)