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NCT03035318 · ClinicalTrials.gov registry record · NA
Comparison of Glenoid Position Using SmartBones
A NA study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- NA
- Development phase
- 126
- Enrollment target
NCT03035318 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 126 participants.
The verdict
NCT03035318, a NA study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 126 participants
- Enrollment target
Study Summary
The investigators propose a randomized clinical trial to evaluate the accuracy of glenoid implant placement comparing four groups of patients. Group 1 consists of 3D imaging and computer-generated surgical planning using standard DePuy instrumentation for placement of the glenoid implant. This group is considered the standard of care. Group 2 consists of 3D imaging and computer-generated surgical planning, with use of a SmartBone to trial the standard DePuy instrumentation. (Group 2 is Group 1 with addition of the use of a SmartBone.) Group 3 consists of 3D imaging and computer-generated surgical planning, with use of the IRI technology including a SmartBone, but with metal legs instead of plastic legs in the IRB#13-652 study. Group 4 consists of 3D imaging and computer-generated surgical planning, with use of the RTI technology including a SmartBone. We will measure implant placement based on 3D CT imaging. We will measure pre-operative bone quality using quantitative CT scan to measure trabecular bone volume and correlate these findings with bone samples removed from the humeral head and measured by microCT and mechanical testing of the bone samples. These bone samples will be obtained as part of the routine preparation of the humeral head for implant placement. This bone tissue is normally removed and discarded as part of the standard of care for preparation of the bone for placement of the humeral stem. By comparing a computer generated pre-operative plan to the post-operative glenoid component placement, we will be looking at three outcomes. First, we will determine the overall difference in glenoid component placement between the four treatment groups. Second, we will compare the placement between the technologies within and among surgeons. Third, we will evaluate the difference in implant position between technologies based on severity of pathology. The quality of the humeral head sample will be correlated to the possible loosening of the implants.
Interventions
- DEVICE DePuy Global® Anchor Peg Glenoid Instrumentation
- DEVICE DePuy Global® Anchor Peg Instrumentation with SmartBone™
- DEVICE IRI with SmartBone™
- DEVICE RTI with SmartBone™
- DEVICE IRI with SmartBase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2014-09 |
| Est. Completion | 2016-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03035318
The ClinicalTrials.gov registry entry for NCT03035318 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which DePuy Global® Anchor Peg Glenoid Instrumentation is the first listed.
NCT03035318 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03035318 about?
NCT03035318 is a clinical study titled "Comparison of Glenoid Position Using SmartBones". The investigators propose a randomized clinical trial to evaluate the accuracy of glenoid implant placement comparing four groups of patients. Group 1 consists of 3D imaging and computer-generated surgical planning using standard DePuy instrumentation for placement of the glenoid implant. This group...
What is the current status of trial NCT03035318?
This trial is currently completed. It is a NA study. The enrollment target is 126 participants. The study started on 2014-09. Estimated completion is 2016-12.
What interventions are being tested in trial NCT03035318?
The interventions under investigation include: DePuy Global® Anchor Peg Glenoid Instrumentation (DEVICE), DePuy Global® Anchor Peg Instrumentation with SmartBone™ (DEVICE), IRI with SmartBone™ (DEVICE), RTI with SmartBone™ (DEVICE), IRI with SmartBase (DEVICE).
Who is sponsoring clinical trial NCT03035318?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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