Study of Surgical Technique With Use of Single-radius Prosthesis in Total Knee Replacement
Status: | Completed |
---|---|
Conditions: | Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/11/2019 |
Start Date: | November 2011 |
End Date: | February 2014 |
Translational Error in Flexion-extension Gap Balancing With Singe Radius Total Knee Arthroplasty
The purpose of this study is to clinically demonstrate a phenomenon of measurement error that
can occur during placement of a specific type of total knee replacement prosthesis (single
radius femoral component) using a certain type of surgical technique (flexion/extension gap
balancing).
can occur during placement of a specific type of total knee replacement prosthesis (single
radius femoral component) using a certain type of surgical technique (flexion/extension gap
balancing).
Inclusion Criteria:
- Scheduled to undergo primary total knee arthroplasty performed by the principal
investigator
- Use of a single radius posterior-stabilized TKA prosthesis is planned
- Spinal anesthetic is planned
- Diagnosis of osteoarthritis
- Has normal knee ligaments with no history of previous injury or surgery to ligaments,
or other pathologic condition
- Has at least 100 degrees knee flexion preoperatively (measured by long goniometer)
- Gives valid informed consent
- Age 18 years or older
Exclusion Criteria:
- Patient receives general anesthetic
- Diagnosis other than osteoarthritis (e.g., rheumatoid arthritis, avascular necrosis,
post-traumatic arthritis)
- History of any prior knee ligament injury, or any surgery to ligaments
- Any connective tissue disease affecting integrity of the ligaments (must have normal
ligaments)
- History of long bone fracture in the affected leg
- Flexion contracture that would interfere with ability to establish extension gap
reliably (judgment of investigator)
- Maximum pre-operative knee flexion is less than 100 degrees.
- Patient is non-ambulatory
- Any preclusion or inability to use navigation
- Treatment with single radius posterior stabilized TKA prosthesis is not indicated
- Participation is not in best interest of patient for any reason
- Cannot or does not give valid informed consent
- Female patient who is currently pregnant
- Age less than 18 years
- Body mass index greater than 40 kg/(m*m)
- Incarcerated
We found this trial at
2
sites
Click here to add this to my saved trials
Click here to add this to my saved trials