Clinical trial NCT03489408: Post-Approval Prospective Study - Conventus CAGE™ PH for Use in Proximal Humerus Fracture Fixation
Official title: Post-Approval Prospective Study - Conventus CAGE™ PH for Use in Proximal Humerus Fracture Fixation - Study ID 5807
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Humeral Fractures, Proximal
Keywords: Proximal humerus fracture fixation
trauma
Lead sponsor: Conventus Orthopaedics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Detailed description: The Conventus CAGE™ PH (PH Cage) System Post-Approval Prospective Study (Study) is a multi-center, prospective, post-approval clinical study designed to collect device and procedure experience in everyday clinical practice.

Specifically, the study will provide:

1. Device safety and patient outcome data.
2. Device usage data.
3. Performance data for the implant procedure.
4. Publications.
5. Early economic benefit data.

Patient Assessments Demographic and general health data will be collected on all patients at the baseline appointment to ensure subjects meet inclusion/exclusion criteria. In addition, to these data, x-rays and adverse event reports related to the implanted device, surgical procedure and/or study data collection methods will be collected.

Patients will be seen at baseline, 2-, 6- and 12-week, 1- and 2-year post op.

Patient participation in this study is voluntary. However, post-implant patient follow-up adds to the medical community's understanding of proximal humerus fracture patient outcomes, as well as the safety and performance of the PH Cage.

Eligibility criteria: Inclusion Criteria:

The following criteria, in accordance with the product labelling (Instructions For Use), should be considered when selecting patients for inclusion in this Study:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Primary performance patient assessment
timeFrame: Change from Baseline in Constant Murley Score at 2-year post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford University Hospital
state: California
city: Torrance
country: United States
facility: Harbor-UCLA
state: California
city: Baltimore
country: United States
facility: The Johns Hopkins University
state: Maryland
city: Duxbury
country: United States
facility: Snug Harbor Orthopedics
state: Massachusetts
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Conventus Orthopaedics, Inc.
name: Carrie Hill
role: STUDY_DIRECTOR
References: