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Trial record 1 of 36 for:    Proximal Humerus Fracture Fixation
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Post-Approval Prospective Study - Conventus CAGE™ PH for Use in Proximal Humerus Fracture Fixation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03489408
Recruitment Status : Terminated (Study stopped due to business decision to not continue to gather clinical evidence on product)
First Posted : April 5, 2018
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Conventus Orthopaedics, Inc.

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.

Condition or disease Intervention/treatment
Humeral Fractures, Proximal Device: Conventus Cage™ PH

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Post-Approval Prospective Study - Conventus CAGE™ PH for Use in Proximal Humerus Fracture Fixation - Study ID 5807
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : February 17, 2020
Actual Study Completion Date : February 17, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Conventus Cage™ PH
    Proximal humeral fracture fixation


Primary Outcome Measures :
  1. Primary performance patient assessment [ Time Frame: Change from Baseline in Constant Murley Score at 2-year post-op ]
    Constant Murley Score



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03489408


Locations
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United States, California
Stanford University Hospital
Redwood City, California, United States, 94063
Harbor-UCLA
Torrance, California, United States, 90509
United States, Maryland
The Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Snug Harbor Orthopedics
Duxbury, Massachusetts, United States, 02332
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Conventus Orthopaedics, Inc.
Investigators
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Study Director: Carrie Hill Conventus Orthopaedics, Inc.
Additional Information:

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Responsible Party: Conventus Orthopaedics, Inc.
ClinicalTrials.gov Identifier: NCT03489408    
Other Study ID Numbers: 5807
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Conventus Orthopaedics, Inc.:
Proximal humerus fracture fixation
trauma
Additional relevant MeSH terms:
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Fractures, Bone
Humeral Fractures
Shoulder Fractures
Wounds and Injuries
Arm Injuries
Shoulder Injuries