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: | Recruiting |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 45 - 80 |
| Updated: | 4/5/2017 |
| Start Date: | May 2014 |
| End Date: | April 2018 |
| Contact: | Christopher R. Anderson, MS, MBA, CCRP |
| Email: | canderson@orthosensor.com |
| Phone: | (954) 372-2641 |
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
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
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
We found this trial at
1
site
Baltimore, Maryland
Principal Investigator: Michael A Mont, MD
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