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Comparison of Glenoid Component Position Using Intelligent Reusable Instrument (IRI) vs Standard Surgical Instruments
NCT01801241 · View on ClinicalTrials.gov ↗
Study Summary
The proposed clinical study will enroll patients indicated for standard of care anatomic total shoulder arthroplasty. They will receive all pre operative testing, intra-operative care including all implants and post operative care that is standard of care and specific to the surgeon and patients decisions for care. The only difference between the study groups will be the type of surgical instruments used to place the glenoid guide pin. In all cases the surgeon is able and allowed to use their own surgical judgment to place the guide pin, prepare the bone and place the desired implant. In cases that are randomized to the IRIS group the surgeon can use any and all of the standard instruments or guides provided by the implant manufacturer as the surgeon would use in the group of patients randomized to the standard surgical group. If the surgeon chooses not to use the IRIS instruments then this would be noted as a deviation in plan, the reasons recorded and the patient would be excluded from the study without post operative imaging and there pre - operative and intra - operative data would be analyzed for the purpose of understanding the reasons for failure of the IRIS technology to provide surgical assistance for guide pin placement. For patients included in the post operative data analysis will a study specific shoulder CT scan prior to discharge from the hospital to assess the position of the implant. Deviation in the location and position of the implant as compared plan will be our primary outcome measure. Investigators will compare difference between technologies, differences within and between surgeons and the influence of the severity of the pre operative pathology on the two methods of surgical care.
Conditions Studied
Interventions
- DEVICE Anatomic TSA using IRI Instrumentation
- PROCEDURE Anatomic Total Shoulder Arthroplasty
Study Locations (1)
Ohio
- Cleveland Clinic Orthopaedic and Rheumatologic Institute — Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2013-01 |
| Est. Completion | 2013-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01801241
The ClinicalTrials.gov registry entry for NCT01801241 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 607 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Anatomic Total Shoulder Arthroplasty appearing as the primary indexed condition, and to 2 interventions — of which Anatomic TSA using IRI Instrumentation is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01801241 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01801241 about?
NCT01801241 is a clinical study titled "Comparison of Glenoid Component Position Using Intelligent Reusable Instrument (IRI) vs Standard Surgical Instruments". The proposed clinical study will enroll patients indicated for standard of care anatomic total shoulder arthroplasty. They will receive all pre operative testing, intra-operative care including all implants and post operative care that is standard of care and specific to the surgeon and patients dec...
What is the current status of trial NCT01801241?
This trial is currently completed. It is a NA study. The enrollment target is 56 participants. The study started on 2013-01. Estimated completion is 2013-12.
What conditions does trial NCT01801241 study?
This clinical trial studies the following conditions: Anatomic Total Shoulder Arthroplasty. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01801241?
The interventions under investigation include: Anatomic TSA using IRI Instrumentation (DEVICE), Anatomic Total Shoulder Arthroplasty (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01801241?
This trial is sponsored by The Cleveland Clinic, which has 607 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01801241 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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