Status:
WITHDRAWN
To Determine the Gait and Functional Improvement in Total Knee Arthroplasty
Lead Sponsor:
LifeBridge Health
Collaborating Sponsors:
Orthosensor, Inc.
Conditions:
Degenerative Arthritis
Eligibility:
All Genders
45-80 years
Phase:
NA
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 correlat...
Eligibility Criteria
Inclusion
- 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
- ligament insufficiencies
- prior surgeries such as:
- ACL or PCL reconstructions
- posterolateral reconstructions
- osteotomies
- tibia plateau fractures
- Range of Motion less than 90 degrees f ) flexion contracture of more than 20 degrees
Exclusion
Key Trial Info
Start Date :
May 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04057885
Start Date
May 15 2017
End Date
July 31 2018
Last Update
February 26 2020
Active Locations (1)
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1
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215