Study of Surgical Technique With Use of Single-radius Prosthesis in Total Knee Replacement
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ClinicalTrials.gov Identifier: NCT01505452
Recruitment Status :
First Posted : January 6, 2012
Last Update Posted : December 19, 2017
Athens Orthopedic Clinic, P.A.
Information provided by (Responsible Party):
Ormonde M. Mahoney, MD, Athens Orthopedic Clinic, P.A.
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).
Difference in varus/vagus laxity of the knee joint measured with the knee positioned at a 90 degree angle with posteriorly stabilized vs. cruciate retaining trails in place. [ Time Frame: At the time of the surgical procedure ]
During the surgical procedure each participant will undergo measurement of varus/valgus laxity (in degrees) at 90 degrees knee flexion using both types of trial implants in sequence. We will evaluate whether the difference of varus/valgus laxity between the two surgical conditions is correlated to change in anterior/posterior relative position of the tibia (relative to femur) measured between the two conditions. A positive correlation between these two variables (change of position to change of laxity) would demonstrate a potential for measurement error that could occur during surgical procedures if position change of the tibia is not accounted for. All outcomes for this study are measured during the surgical procedure.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Clinic based population (patients undergoing total knee replacement at an orthopedic surgery clinic).
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
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