Humeral Fractures, ProximalNCT03489408
Post-Approval Prospective Study - Conventus CAGE™ PH for Use in Proximal Humerus Fracture Fixation
An observational study of Humeral Fractures, Proximal, run by Conventus Orthopaedics, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Humeral Fractures, Proximal
- What is being tested?
- Conventus Cage™ PH
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Feb 2018to 17 Feb 2020
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
The Johns Hopkins University
Baltimore, Maryland, 21205
Snug Harbor Orthopedics
Duxbury, Massachusetts, 02332
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Stanford University Hospital
Redwood City, California, 94063
Harbor-UCLA
Torrance, California, 90509
About this study
Official title: Post-Approval Prospective Study - Conventus CAGE™ PH for Use in Proximal Humerus Fracture Fixation - Study ID 5807
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.
Read the 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:
- Device safety and patient outcome data.
- Device usage data.
- Performance data for the implant procedure.
- Publications.
- 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.
- Conditions
- Humeral Fractures, Proximal
- Being tested
- Conventus Cage™ PH
- Keywords
- Proximal humerus fracture fixation, trauma
- Medical subject headings
- Shoulder Fractures, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventus Cage™ PHDevice
Proximal humeral fracture fixation
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary performance patient assessment
Constant Murley Score
Measured: Change from Baseline in Constant Murley Score at 2-year post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start1 Feb 2018
- Primary completion17 Feb 2020
- Study completion17 Feb 2020
Why it stopped: Study stopped due to business decision to not continue to gather clinical evidence on product
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humeral Fractures, ProximalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Conventus Orthopaedics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carrie Hill, Study director, Conventus Orthopaedics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489408
- Sponsor's protocol ID
- 5807
- Status last verified
- Jan 2020
- First submitted
- 16 Feb 2018
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Approval Prospective Study - Conventus CAGE™ PH for Use in Proximal Humerus Fracture Fixation - Study ID 5807
- ClinicalTrials.gov ID
- NCT03489408
- Acronym / sponsor ID
- 5807
- Conditions
- Humeral Fractures, Proximal
- Keywords
- Proximal humerus fracture fixation, trauma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study stopped due to business decision to not continue to gather clinical evidence on product
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Conventus Orthopaedics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 17 Feb 2020 (actual)
- Study completion
- 17 Feb 2020 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Device safety and patient outcome data.
- Device usage data.
- Performance data for the implant procedure.
- Publications.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventus Cage™ PHProximal humeral fracture fixation | Device | – |
Primary outcome
Primary performance patient assessment
Time frame: Change from Baseline in Constant Murley Score at 2-year post-op
Constant Murley Score
Results and safety
The study was stopped early (reason given: Study stopped due to business decision to not continue to gather clinical evidence on product). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carrie Hill study director
Conventus Orthopaedics, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Humeral Fractures, Proximal, run by Conventus Orthopaedics, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study stopped due to business decision to not continue to gather clinical evidence on product). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary performance patient assessment (time frame: Change from Baseline in Constant Murley Score at 2-year post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.