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NCT01124305 · ClinicalTrials.gov registry record · Phase 4
Knee Arthroplasty Performed With Conventional and Customized Instrumentation
A Phase 4 study, sponsored by Anderson Orthopaedic Research Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 70
- Enrollment target
NCT01124305 is a Phase 4 study that has completed, run by Anderson Orthopaedic Research Institute. The registered enrollment target is 70 participants.
The verdict
NCT01124305, a Phase 4 study, has completed, sponsored by Anderson Orthopaedic Research Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 70 participants
- Enrollment target
Study Summary
The main purpose of this study is to determine whether the surgical time required for primary total knee arthroplasty is significantly less when performed with Customized Patient Instrumentation (CPI) than with conventional instrumentation. Each case will be recorded by video camera, in order to time the length of surgery and each surgical step. The number of surgical trays required for each case will be recorded. As an additional endpoint, the investigators will measure limb and component alignment on x-rays to determine if these two methods achieve equivalent alignment results. The thickness of bone cuts will be compared to the surgical plan and to each other. The primary hypothesis is that the use of customized patient instrumentation will reduce the operative time required for total knee arthroplasty.
Interventions
- DEVICE Customized Patient Instrumentation
- DEVICE Traditional Instrumentation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2010-05 |
| Est. Completion | 2012-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01124305
The ClinicalTrials.gov registry entry for NCT01124305 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Anderson Orthopaedic Research Institute, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Customized Patient Instrumentation is the first listed.
NCT01124305 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01124305 about?
NCT01124305 is a clinical study titled "Knee Arthroplasty Performed With Conventional and Customized Instrumentation". The main purpose of this study is to determine whether the surgical time required for primary total knee arthroplasty is significantly less when performed with Customized Patient Instrumentation (CPI) than with conventional instrumentation. Each case will be recorded by video camera, in order to tim...
What is the current status of trial NCT01124305?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 70 participants. The study started on 2010-05. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01124305?
The interventions under investigation include: Customized Patient Instrumentation (DEVICE), Traditional Instrumentation (DEVICE).
Who is sponsoring clinical trial NCT01124305?
This trial is sponsored by Anderson Orthopaedic Research Institute, which has 7 total clinical trials registered on ClinicalTrials.gov.
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