Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-24 @ 3:14 PM
NCT ID:
NCT01714492
Brief Summary:
Utilize previously developed mathematical model to determine in vivo knee mechanics (kinematics, forces, stresses, areas and sound) for subjects having a Sigma Posterior Stabilizing (PS) mobile bearing (MB) total knee arthroplasty (TKA). There are several hypotheses for this study, although the most prominent is: Subjects having a Sigma RP PS TKA will experience polyethylene bearing rotation at 10 years post-operative, similar to their previous evaluations at six months, two years and five years.
Detailed Description:
Additional hypotheses:
* Subjects having a Sigma RP PS TKA will experience full ideal femorotibial contact mechanics.
* Subjects having a Sigma RP PS TKA will experience optimal cam/post mechanics.
* Subjects having a Sigma RP PS TKA will experience continuous axial rotation in deep flexion.
* Subjects having a Sigma RP PS TKA will experience optimal distribution of tibio-femoral and cam/post contact forces over a broad area on the post.
* Subjects having a Sigma RP PS TKA will experience a smooth transition of the cam on the post, not an abrupt slide as seen with fixed bearing PS TKA.
* The use of the sound sensors will detect cam/post contact mechanics under in vivo conditions.
Study:
NCT01714492
Study Brief:
Protocol Section:
NCT01714492