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NCT01791738 · ClinicalTrials.gov registry record · Phase 1
Acetabular Shell Positioning Using Patient Specific Instruments
A Phase 1 study of Rheumatoid Arthritis and Avascular Necrosis, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT01791738 is a Phase 1 study of Rheumatoid Arthritis and Avascular Necrosis that has completed, run by The Cleveland Clinic. The registered enrollment target is 36 participants, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01791738, a Phase 1 study of Rheumatoid Arthritis and Avascular Necrosis, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (99% lower). The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
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.
NCT01791738 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
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.
What interventions are being tested in trial NCT01791738?
The interventions under investigation include: Acetabular positioning system (PROCEDURE).
Who is sponsoring clinical trial NCT01791738?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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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Related
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