Study of Surgical Technique With Use of Single-radius Prosthesis in Total Knee Replacement
This study is currently recruiting participants.
Verified January 2012 by Athens Orthopedic Clinic, P.A.
Sponsor:
Athens Orthopedic Clinic, P.A.
Collaborator:
Stryker Orthopaedics
Information provided by (Responsible Party):
Ormonde M. Mahoney, MD, Athens Orthopedic Clinic, P.A.
ClinicalTrials.gov Identifier:
NCT01505452
First received: January 4, 2012
Last updated: January 5, 2012
Last verified: January 2012
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Purpose
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).
| Condition |
|---|
|
Arthritis of Knee |
| Study Type: | Observational |
| Study Design: | Time Perspective: Cross-Sectional |
| Official Title: | Translational Error in Flexion-extension Gap Balancing With Singe Radius Total Knee Arthroplasty |
Resource links provided by NLM:
Further study details as provided by Athens Orthopedic Clinic, P.A.:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Clinic based population (patients undergoing total knee replacement at an orthopedic surgery clinic).
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01505452
Contacts
| Contact: Tracy L Kinsey, MSPH | 706-549-1663 ext 3275 | tracy@aocfoundation.org |
Locations
| United States, Georgia | |
| St Mary's Hospital | Recruiting |
| Athens, Georgia, United States, 30606 | |
| Athens Orthopedic Clinic | Recruiting |
| Athens, Georgia, United States, 30606 | |
Sponsors and Collaborators
Athens Orthopedic Clinic, P.A.
Stryker Orthopaedics
Investigators
| Principal Investigator: | Ormonde M Mahoney, MD | Athens Orthopedic Clinic |
More Information
No publications provided
| Responsible Party: | Ormonde M. Mahoney, MD, Principal Investigator, Athens Orthopedic Clinic, P.A. |
| ClinicalTrials.gov Identifier: | NCT01505452 History of Changes |
| Other Study ID Numbers: | AOC-OM-Stryker-2009-0019 |
| Study First Received: | January 4, 2012 |
| Last Updated: | January 5, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Arthritis Joint Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013