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Lead Investigator no longer with institution
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| Name | Class |
|---|---|
| Orthosensor, Inc. | INDUSTRY |
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This is an observational study to understand the effects of soft-tissue balancing on gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty
The primary objectives of this study are to understand the effects of soft-tissue balancing on Gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty and to correlate Intra-operative subjective feel with OrthoSensor Outputs
Secondary objectives are to quantify and observe pain medication use, swelling, muscle strength and girth, gait efficiency, patient satisfaction, activity levels, functional return (i.e., back to work, resume normal activities) and patient perception of a balanced knee
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device Arm | Experimental | A prospective series of 10 patients will receive sensor-guided TKA using the this special Orthosensorâ„¢ VERASENSEâ„¢ Knee System assisted surgery for optimization of soft tissue balance |
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| Standard of Care | Active Comparator | 10 patients will receive standard of care. Prior to cementing final implants, VERASENSE will be utilized with the standard of care group with the surgeon blinded to the data. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orthosensorâ„¢ VERASENSEâ„¢ Knee System | Device | A group of patients will receive a total knee arthroplasty using the Orthosensor device |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with improvement in gait. | 18 months | |
| Proportion of patients not requiring long term rehabilitation. | 18 months | |
| Proportion of patients with improved function as measured by standardized knee scores. | 18 months |
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Inclusion Criteria:
Subject must be a candidate for a primary PCL retaining total knee arthroplasty
Subject must be diagnosed with one or more of the following conditions:
Subject is likely to be available for all study visits
Subject is able and willing to sign the informed consent and follow study procedures
Exclusion Criteria
Prior total knee arthroplasty
ligament insufficiencies
prior surgeries such as:
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| Name | Affiliation | Role |
|---|---|---|
| Michael A. Mont, M.D. | Director, Rubin Institute for Advanced Orthopedics and Joint Preservation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | United States |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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