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NCT01797731 · ClinicalTrials.gov registry record · NA
Conventional Alignment System Versus Surgical Navigation System in Total Knee Arthroplasty
A NA study, sponsored by Hospital for Special Surgery, New York.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
NCT01797731 is a NA study that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 100 participants.
The verdict
NCT01797731, a NA study, has completed, sponsored by Hospital for Special Surgery, New York.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
Study Summary
This is a randomized, controlled, blinded prospective study comparing the use of the usual cutting guides with a palm-sized digital surgical navigation system in unilateral total knee arthroplasty. Analysis of pre- and post-operative X-rays will be used to compare alignment of the tibial (shinbone) implant components. The investigators expect that the FDA-approved hand-held surgical navigation device will increase the accuracy and precision of the tibial cut by telling the surgeon the exact position of the cutting block before the surgeon makes the cut, allowing minor adjustments to be made. The investigators expect the conventional device to take less time to use, but that this difference will decrease as the surgeon becomes more familiar with the device. The investigators expect the intraoperative measurements acquired by the KneeAlign system to strongly correlate with the radiographic alignments measured postoperatively.
Interventions
- DEVICE Digital hand-held surgical navigation system
- DEVICE Conventional tibial extramedullary alignment system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2010-12 |
| Est. Completion | 2013-09-16 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01797731
The ClinicalTrials.gov registry entry for NCT01797731 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hospital for Special Surgery, New York, which has 194 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Digital hand-held surgical navigation system is the first listed.
NCT01797731 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01797731 about?
NCT01797731 is a clinical study titled "Conventional Alignment System Versus Surgical Navigation System in Total Knee Arthroplasty". This is a randomized, controlled, blinded prospective study comparing the use of the usual cutting guides with a palm-sized digital surgical navigation system in unilateral total knee arthroplasty. Analysis of pre- and post-operative X-rays will be used to compare alignment of the tibial (shinbone) ...
What is the current status of trial NCT01797731?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2010-12. Estimated completion is 2013-09-16.
What interventions are being tested in trial NCT01797731?
The interventions under investigation include: Digital hand-held surgical navigation system (DEVICE), Conventional tibial extramedullary alignment system (DEVICE).
Who is sponsoring clinical trial NCT01797731?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
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