View Clinical Trial (Medical Research Study)
Translational Error in Flexion-extension Gap Balancing With Singe Radius Total Knee Arthroplasty
| City: |
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Athens |
| State: |
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Georgia |
| Zip Code: |
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30606 |
| Conditions: |
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Arthritis of Knee |
| Purpose: |
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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).
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| Study Summary: |
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| Criteria: |
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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
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| NCT ID: |
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NCT01505452 |
| Primary Contact: |
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Principal Investigator
Ormonde M Mahoney, MD
Athens Orthopedic Clinic
Tracy L Kinsey, MSPH
Phone: 706-549-1663 ext. 3275
Email: tracy@aocfoundation.org
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| Backup Contact: |
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N/A |
| Location Contact: |
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Athens, Georgia 30606
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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