Status:
COMPLETED
Study of Surgical Technique With Use of Single-radius Prosthesis in Total Knee Replacement
Lead Sponsor:
Athens Orthopedic Clinic, P.A.
Collaborating Sponsors:
Stryker Orthopaedics
Conditions:
Arthritis of Knee
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01505452
Start Date
November 1 2011
End Date
February 1 2014
Last Update
January 9 2019
Active Locations (2)
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1
Athens Orthopedic Clinic
Athens, Georgia, United States, 30606
2
St Mary's Hospital
Athens, Georgia, United States, 30606