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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: Completed NA study, sponsored by The Cleveland Clinic.
NCT03035318 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 126 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The overall distance between glenoid component placement between Standard Manufacturer Instrumentation and Patient Specific Instrumentation will be compared (Inclination and Version).
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 |
What the finished NCT03035318 record still lists
NCT03035318 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 5 interventions - of which DePuy Global® Anchor Peg Glenoid Instrumentation is the first listed.
NCT03035318 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03035318's enrollment target sits among peer trials
126 749th of 2000 higher than 1,248 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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