How TKA Implants Affect Muscle Quality and Activity During Daily Living and Immunological Response
Summary
Sixty patients will be randomly assigned to receive either a Smith & Nephew Journey II or Zimmer NexGen LPS-Flex knee implant. Patients will undergo biomechanics testing while they complete sit-to-stand, stand-to-sit, lateral step down, level walking, and single leg balance tasks up to 1 month before surgery, and 6 and 12 months after surgery. They will also undergo MRI imaging up to 1 month before surgery and 12 months after surgery to assess muscle quality. A secondary outcome will also be to analyze the immunological response in the patients who received femoral components made of oxidized zirconium versus contemporary components made of cobalt chrome. Fifteen healthy controls will also participate in the study and will undergo the biomechanical, MRI and blood draws at a single visit.
Study Design
Conditions
Osteoarthritis, Knee
Intervention
Zimmer NexGen LPS-Flex, Smith & Nephew Journey II
Location
The Ottawa Hospital
Ottawa
Ontario
Canada
K1H 8L6
Status
Recruiting
Source
Ottawa Hospital Research Institute
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT04105179
- ClinicalTrials.gov processed this data on September 30, 2019
Published on BioPortfolio: 2019-10-01T07:54:59-0400
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Medical and Biotech [MESH] Definitions
Osteoarthritis, Knee
Noninflammatory degenerative disease of the knee joint consisting of three large categories: conditions that block normal synchronous movement, conditions that produce abnormal pathways of motion, and conditions that cause stress concentration resulting in changes to articular cartilage. (Crenshaw, Campbell's Operative Orthopaedics, 8th ed, p2019)
Gracilis Muscle
A slender and most superficial muscle in the inner THIGH which originates at the ramus of the PUBIC BONE near the PUBIC SYMPHYSIS and inserts at the proximal medial TIBIA. Its function is to abduct thigh, flex knee, and rotate leg medially. It is a common source of a MYOCUTANEOUS FLAP.
Lysholm Knee Score
An instrument used to assess the results of rehabilitation from knee injuries, especially those requiring ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. It measures recovery of knee joint function based on ACTIVITIES OF DAILY LIVING.
Knee Injuries
Injuries to the knee or the knee joint.
Knee
A region of the lower extremity immediately surrounding and including the KNEE JOINT.
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