Trials / Terminated
TerminatedNCT02290119
Gait and Functional Improvement in Total Knee Arthroplasty With the Use of Verasense for Soft Tissue Balancing
PILOT STUDY: Gait and Functional Improvement in Total Knee Arthroplasty With the Use of Verasense for Soft Tissue Balancing: A Randomized, Double-Blind, Controlled Trial
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Orthosensor, Inc. · Industry
- Sex
- All
- Age
- 45 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
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: * Pain medication use * Swelling * Muscle strength and girth * Gait efficiency * Patient satisfaction * Activity levels, functional return (i.e., back to work, resume normal activities) * Patient perception of a balanced knee
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Sensor-assisted TKR (Verasense) | 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. |
| PROCEDURE | Control - Without the use of Verasense | Patients in this cohort will undergo manual total knee replacement without the use of Verasense |
Timeline
- Start date
- 2018-04-01
- Primary completion
- 2022-10-12
- Completion
- 2022-10-12
- First posted
- 2014-11-13
- Last updated
- 2023-02-06
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02290119. Inclusion in this directory is not an endorsement.