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Study stopped due to business decision to not continue to gather clinical evidence on product
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The Conventus CAGEâ„¢ 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.
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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventus Cage PH device | Device | The Conventus CAGEâ„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Change from Baseline in Constant Murley Score at the 2 year post op |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be enrolled from the community in which the study is being conducted.
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| Name | Affiliation | Role |
|---|---|---|
| James M Gregory, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Carrie M Hill | Conventus Orthopaedics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
Data collected will be used to support publications; all IPD that underlie results in a publication
The data will become available once the study concludes (>2 years from date of first enrollment, until last patient followed) Data will be publicly available via any publications developed from this study. Length of availability will be determined by the publishing party.
Data will be publicly available via any publications developed from this study.
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| ID | Term |
|---|---|
| D012784 | Shoulder Fractures |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D000070599 | Shoulder Injuries |
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