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as a result of Orthosensor's acquisition by Stryker in July 2018.No final mutually agreed (signed) protocol was found and no clear records of the study data can be retrieved. No accurate and reliable results of this study can be posted.
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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 correlate Intra-operative subjective feel with OrthoSensor Outputs
Secondary objectives are to quantify and observe:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control - Without the use of Verasense | Sham Comparator | Total Knee Replacement without the use of intraoperative sensors |
|
| Sensor-assisted TKR (Verasense) | Active Comparator | Total Knee Replacement with the use of intraoperative sensors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sensor-assisted TKR (Verasense) | Device | Verasense is a single use, disposable device embedded with microelectronics into a standard tibial trial to provide dynamic, intraoperative feedback regarding limb alignment, tibiofemoral position and quantitative pressure at peak contact points in the medial and lateral compartments during total knee replacement surgery. Utilizing sensor-derived data, the surgeon can now evaluate intercompartmental loading throughout the range of motion, and correct for soft-tissue abnormalities while receiving real-time feedback regarding joint balance. |
| Measure | Description | Time Frame |
|---|---|---|
| Rehabilitation Potential | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Society Pain and Functional Scoring (KSS) | The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ron Delanois, MD | Sinai Hospital of Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sinai Hospital of Baltimore - Rubin Institute of Advanced Orthopedics Center for Joint Preservation and Reconstruction | Baltimore | Maryland | 21215-5271 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 15, 2026 |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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|
| Control - Without the use of Verasense | Procedure | Patients in this cohort will undergo manual total knee replacement without the use of Verasense |
|
| 6 month |
| Forgotten Joint Score (FJS) | The FJS is based on the patients' ability to forget about a joint as a result of the treatment. The FJS assessment is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities. | 6 month |
| 3D Gait Analysis velocity | 3D gait analysis relates to the range of motion of a joint and the movement velocity. The mean gait speed analysis is considered higher than 1 m/s. | 6 Month |