Purpose

The Conventus CAGE™ PH (PH Cage) System Post-Approval Observational Data Collection Study (Study) is a single center, prospective, post-approval clinical study designed to collect device and procedure experience in everyday clinical practice.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patient must be of at least legal age of consent according to applicable State Law.
  • Patient is able to understand and provide written consent

Exclusion Criteria

  • The PH Cage should not be implanted in patients with suspected or known allergies to titanium or nickel.
  • Pregnant female patients.
  • Patients with current or history of mental illness and/or senility.
  • Patients with current or history of alcoholism and/or chemical substance abuse.
  • Patient has a medical condition(s) that preclude 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 known pre-existing rotator cuff disease.
  • 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.

Study Design

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Prospective

More Details

Status
Terminated
Sponsor
Conventus Orthopaedics, Inc.

Study Contact

Detailed Description

The study is a prospective, non-randomized, post-market approval data collection study that is designed to collect device/procedure and outcome data on patients who have experienced proximal humerus bone fractures and received a PH Cage.

Specifically, the study will provide:

1. Patient outcome and performance data for the implant and implant procedure that that may be used to support scientific publications.

2. Assurance of continued product safety and effectiveness.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.