A PILOT STUDY: To Determine the Gait and Functional Improvement in Total Knee Arthroplasty With Use of Orthosensor™ VERASENSE™ Knee System for Soft Tissue Balancing.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Degenerative Arthritis
- Sponsor
- LifeBridge Health
- Locations
- 1
- Primary Endpoint
- Proportion of patients with improved function as measured by standardized knee scores.
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
Brief Summary
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
Detailed Description
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
Investigators
Eligibility Criteria
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:
- •osteoarthritis
- •avascular necrosis
- •rheumatoid or other inflammatory arthritis
- •post-traumatic arthritis Minimum age: 45 Maximum age: 80
- •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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Proportion of patients with improved function as measured by standardized knee scores.
Time Frame: 18 months
Proportion of patients with improvement in gait.
Time Frame: 18 months
Proportion of patients not requiring long term rehabilitation.
Time Frame: 18 months