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This is a single center randomized observational study that evaluates the cost benefit ratio between the use of two types of instrumentation in TKA: standard instrumentation vs. VISIONAIREâ„¢ Patient Matched Technology. This study does not involve treatment or investigational products, as all components are FDA approved and are commercially available.
The objective of the current observational study is to assess value of surgical instrumentation following analysis of health economic data. It is hypothesized that patient matched cutting block technology VISIONAIREâ„¢ may reduce TKA operative time, blood loss, surgical error and adverse event risk as well as providing improved mechanical alignment. In order to test this hypothesis, subjects will be randomized to either VISIONAIREâ„¢ or standard TKA instrumentation groups. One site will enroll a total of 38 patients; 19 patients per group. All patients meeting the inclusion/exclusion criteria specified in this protocol will be asked to participate in the study. If the patient consents to participate, they will be enrolled in the study and randomized to one of the two study arms. Patients requiring TKA will be implanted with Legion, Genesis II or Journey BCS (Smith & Nephew) total knee implant systems. Standard instrumentation will be used to assist the surgeon in placing the implant in the control group. In the VISIONAIREâ„¢ group, standard instrumentation will not be used in the surgery. Patients randomized to the VISIONAIREâ„¢ arm will have an MRI preoperatively that will be used to create the customized cutting blocks. All patients will have an x-ray at each postoperative interval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VISIONAIREâ„¢ | Total knee arthroplasty with VISIONAIREâ„¢ patient-matched cutting blocks | ||
| Standard Instrumentation | Total knee arthroplasty with standard instrumentation |
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| Measure | Description | Time Frame |
|---|---|---|
| Health Economic Criteria | This study will evaluate the cost benefit ratio between the use of two types of instrumentation in TKA: standard instrumentation vs. VISIONAIREâ„¢. The following will be collected & reported from the OR and discharge report:
| Up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a measure of Safety and Tolerability | Radiographic analysis will be conducted to assess preoperative and postoperative mechanical alignment between groups. All perioperative and postoperative surgical or instrument-related adverse events will be recorded during this study. | Perioperative & Postoperative (up to 6 weeks) |
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Inclusion Criteria:
Patients must meet all of the inclusion criteria.
Exclusion Criteria:
Patients must not meet any of the exclusion criteria.
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The patient population considered for this study includes patients with osteoarthritis (degenerative joint disease)of the knee requiring unilateral TKA.
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| Name | Affiliation | Role |
|---|---|---|
| John Noble, Jr, M.D. | Center for Orthopaedics Lake Charles, LA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Noble, Jr. | Lake Charles | Louisiana | 70605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | J Arthroplasty. 2011 Sep 9. [Epub ahead of print] http://www.ncbi.nlm.nih.gov/pubmed/21908169 | ||
| 21908169 | Result | Noble JW Jr, Moore CA, Liu N. The value of patient-matched instrumentation in total knee arthroplasty. J Arthroplasty. 2012 Jan;27(1):153-5. doi: 10.1016/j.arth.2011.07.006. Epub 2011 Sep 9. |
| Label | URL |
|---|---|
| The Value of Patient-Matched Instrumentation in Total Knee Arthroplasty. | View source |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| D012216 |
| Rheumatic Diseases |