Proximal Humeral FractureNCT03711591
Single Center Post Approval Proximal Humerus Fixation With the Conventus Cage PH™ Device
An observational study of Proximal Humeral Fracture, run by Conventus Orthopaedics, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proximal Humeral Fracture
- What is being tested?
- Conventus Cage PH device
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2018to 17 Feb 2020
- 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: Subjects will be enrolled from the community in which the study is being conducted.
Who may be able to join
- Patient must be of at least legal age of consent according to applicable State Law.
- Patient is able to understand and provide written consent
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Proximal Humerus Fixation With the Conventus Cage™ PH Device A Post-Approval Observational Data Collection Study, A Single-Center Study, Memorial Hermann
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.
Read the 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:
- Patient outcome and performance data for the implant and implant procedure that that may be used to support scientific publications.
- Assurance of continued product safety and effectiveness.
- Conditions
- Proximal Humeral Fracture
- Being tested
- Conventus Cage PH device
- Keywords
- Proximal humerus fracture fixation, Trauma, Proximal Humerus, Fixation
- 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 PH deviceDevice
The Conventus CAGE™ PH (PH Cage) is a permanent implant comprised of an expandable scaffold, made from nitinol and titanium, which is deployed into the medullary canal and provides a structure to which fractured bone fragments are attached using fragment screws.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Performance Patient Assessment
Constant Murley Score (CMS) The Constant Murley Score is a combination of visual analog scales assessing pain, activities of daily living and assessments of range of motion and strength using a long-armed goniometer and isometer. The higher the score the better for the following sections of the CMS: A. Pain (0-15 points) (e.g.15=no pain, 2=high pain), B. Everyday activities-question 1 (0-2 points) (e.g. 2=best, 0=worst), questions 2 and 3(0-4 points) (the higher the score the better), question 4 (0-10 points) C. Movement- questions 1 and 2 (0-20 points) (e.g. the greater the range of motion performed, the more points assigned), questions 3 and 4 (0-10 points) (e.g. points assigned based on movements performed) D. Strength (0-25 points) Score is calculated from the highest score of three attempts, with each score corresponding to the force in pounds (max 25 points) The overall score is then calculated by combining all sections (A+B+C+D= 0-100 points)
Measured: Change from Baseline in Constant Murley Score at the 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 posted18 Oct 2018
- Study start29 Nov 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 Proximal Humeral FractureStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Conventus Orthopaedics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James M Gregory, MD, Principal investigator, The University of Texas Health Science Center, HoustonCarrie M Hill, Study director, Conventus Orthopaedics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711591
- Sponsor's protocol ID
- 7821
- Status last verified
- Sep 2019
- First submitted
- 27 Sep 2018
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data collected will be used to support publications; all IPD that underlie results in a publication
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
- Proximal Humerus Fixation With the Conventus Cage™ PH Device A Post-Approval Observational Data Collection Study, A Single-Center Study, Memorial Hermann
- ClinicalTrials.gov ID
- NCT03711591
- Acronym / sponsor ID
- 7821
- Conditions
- Proximal Humeral Fracture
- Keywords
- Proximal humerus fracture fixation, Trauma, Proximal Humerus, Fixation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study stopped due to business decision to not continue to gather clinical evidence on product
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Conventus Orthopaedics, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 17 Feb 2020 (actual)
- Study completion
- 17 Feb 2020 (actual)
- First posted
- 18 Oct 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 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.
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:
- Patient outcome and performance data for the implant and implant procedure that that may be used to support scientific publications.
- Assurance of continued product safety and effectiveness.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be enrolled from the community in which the study is being conducted.
Key inclusion criteria (2 listed)
- Patient must be of at least legal age of consent according to applicable State Law.
- Patient is able to understand and provide written consent
Key exclusion criteria (11 listed)
- 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.
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 PH deviceThe Conventus CAGE™ PH (PH Cage) is a permanent implant comprised of an expandable scaffold, made from nitinol and titanium, which is deployed into the medullary canal and provides a structure to which fractured bone fragments are attached using fragment screws. | Device | – |
Primary outcome
Primary Performance Patient Assessment
Time frame: Change from Baseline in Constant Murley Score at the 2 year post op
Constant Murley Score (CMS) The Constant Murley Score is a combination of visual analog scales assessing pain, activities of daily living and assessments of range of motion and strength using a long-armed goniometer and isometer. The higher the score the better for the following sections of the CMS: A. Pain (0-15 points) (e.g.15=no pain, 2=high pain), B. Everyday activities-question 1 (0-2 points) (e.g. 2=best, 0=worst), questions 2 and 3(0-4 points) (the higher the score the better), question 4 (0-10 points) C. Movement- questions 1 and 2 (0-20 points) (e.g. the greater the range of motion performed, the more points assigned), questions 3 and 4 (0-10 points) (e.g. points assigned based on movements performed) D. Strength (0-25 points) Score is calculated from the highest score of three attempts, with each score corresponding to the force in pounds (max 25 points) The overall score is then calculated by combining all sections (A+B+C+D= 0-100 points)
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: Yes. Data collected will be used to support publications; all IPD that underlie results in a publication
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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.
James M Gregory, MD principal investigator
The University of Texas Health Science Center, Houston
Carrie M Hill study director
Conventus Orthopaedics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proximal Humeral Fracture, run by Conventus Orthopaedics, Inc. at 1 site 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 2 inclusion and 11 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 1 site 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 the 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.