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Acetabular Shell Positioning Using Patient Specific Instruments
NCT01791738 · View on ClinicalTrials.gov ↗
Study Summary
The proposed study is a double-blinded randomized controlled trial comparing patient specific instruments with solely standardized instruments and pre-operative planning used for the placement of the acetabular cup prosthesis used in total hip arthroplasty. The investigators will enroll 36 patients who have consented to total hip arthroplasty for treatment of hip pathology. This treatment is a standard of care. Patients will receive standard of care pre- and post-operative care and placement of standard of care implants all of which are commercially available and FDA approved for general use for the clinical indications used in these patients. All patients will receive a pre-operative CT scan for surgical planning and comparison with post-operative CT scan. The difference in intervention between the groups will be the creation and use of patient specific instruments from the pre-operative planning session. These instruments will be used for placement of an indexing peripheral guide wire to direct acetabular preparation and placement of the shell assisting standard surgical instruments. Print-offs from the pre-operative plan will also be used in the treatment group. The post-operative scan will be performed within two weeks of the surgery for both the treatment and control groups. The investigators will analyze the difference in acetabular shell placement (acetabular version and abduction angle) from the pre-operatively planned CT scan. These differences will be compared between the control and experimental groups.
Conditions Studied
Interventions
- PROCEDURE Acetabular positioning system
Study Locations (1)
Ohio
- The Cleveland Clinic — Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2011-01 |
| Est. Completion | 2012-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01791738
The ClinicalTrials.gov registry entry for NCT01791738 describes a study currently listed as completed. It is categorized as Phase 1, 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 36 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 3 conditions, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 1 intervention — of which Acetabular positioning system 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: NCT01791738 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 NCT01791738 about?
NCT01791738 is a clinical study titled "Acetabular Shell Positioning Using Patient Specific Instruments". The proposed study is a double-blinded randomized controlled trial comparing patient specific instruments with solely standardized instruments and pre-operative planning used for the placement of the acetabular cup prosthesis used in total hip arthroplasty. The investigators will enroll 36 patients...
What is the current status of trial NCT01791738?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2011-01. Estimated completion is 2012-04.
What conditions does trial NCT01791738 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis, Avascular Necrosis, Osteoarthritis, Hip. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01791738?
The interventions under investigation include: Acetabular positioning system (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01791738?
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 NCT01791738 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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