NCT02290119
Terminated
Not Applicable
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
ConditionsOsteoarthritis
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Orthosensor, Inc.
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Rehabilitation Potential
Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •Subject is between the age of 45 - 80 years
- •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 ACL or PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
- •Range of Motion less than 90 degrees, flexion contracture of more than 20 degrees
Outcomes
Primary Outcomes
Rehabilitation Potential
Time Frame: 6 Months
Secondary Outcomes
- Knee Society Pain and Functional Scoring (KSS)(6 month)
- 3D Gait Analysis velocity(6 Month)
- Forgotten Joint Score (FJS)(6 month)
Investigators
Study Sites (1)
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