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NCT01084772 · ClinicalTrials.gov registry record · NA
Visionaire™ Versus Standard Instrumentation Safety and Efficacy in Total Knee Arthroplasty (TKA)
A NA study, sponsored by Smith & Nephew.
- Terminated
- Registry status
- NA
- Development phase
- 134
- Enrollment target
NCT01084772: Clinical Trial NA study, sponsored by Smith & Nephew.
NCT01084772 is a NA study that was terminated before completion, run by Smith & Nephew. The registered enrollment target is 134 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01084772, a NA study, was terminated before completion, sponsored by Smith & Nephew.
- TERMINATED
- Registry status
- NA
- Development phase
- 134 participants
- Enrollment target
Study Summary
The objective of this study is to assess outcomes following TKA, utilizing two surgical techniques. Patients will be randomized to one of two arms: TKA with standard instrumentation and TKA with VISIONAIRE™ patient-matched cutting blocks. Data will be collected at preoperative, operative/discharge, 3 months, 1 year and 2 years after TKA. The secondary objective of this study is to compare the safety, quality of life, and economic outcomes of TKA when these two techniques are utilized. This study does not involve treatment or investigational products, as all components are FDA cleared and are commercially available.
Primary Outcome
The KSS was used to rate both the prosthesis function and the patient's functional abilities after TKA. The KSS Total Score (0-100 points) included a combined evaluation of joint motion (0-25 points), instability (0-25 points), alignment (0-25 points), and symptoms (0-25 points). A higher score indicated a better outcome for subjects.
Interventions
- OTHER VISIONAIRE Total Knee Arthroplasty
- OTHER Standard Total Knee Arthroplasty
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2012-06-21 |
| Est. Completion | 2015-09 |
| Phase | NA |
Why NCT01084772 stopped before completion
NCT01084772 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which VISIONAIRE Total Knee Arthroplasty is the first listed.
NCT01084772 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01084772 about?
NCT01084772 is a clinical study titled "Visionaire™ Versus Standard Instrumentation Safety and Efficacy in Total Knee Arthroplasty (TKA)". The objective of this study is to assess outcomes following TKA, utilizing two surgical techniques. Patients will be randomized to one of two arms: TKA with standard instrumentation and TKA with VISIONAIRE™ patient-matched cutting blocks. Data will be collected at preoperative, operative/discharge, ...
What is the current status of trial NCT01084772?
This trial is currently terminated. It is a NA study. The enrollment target is 134 participants. The study started on 2012-06-21. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01084772?
The interventions under investigation include: VISIONAIRE Total Knee Arthroplasty (OTHER), Standard Total Knee Arthroplasty (OTHER).
Who is sponsoring clinical trial NCT01084772?
This trial is sponsored by Smith & Nephew, which has 72 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01084772's enrollment target sits among peer trials
134 728th of 2000 higher than 1,272 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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