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Mechanics Analysis of Patients Having a Sigma Mobile Bearing TKA

NCT01714492 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DEVICE Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly

Study Locations (3)

Tennessee

  • Perkins Hall, The University of Tennessee — Knoxville
  • Science and Engineering Research Facility, The University of Tennessee — Knoxville

Colorado

  • Porter Adventist Hospital, Colorado Joint Replacement — Denver

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2012-04
Est. Completion 2012-11

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01714492

The ClinicalTrials.gov registry entry for NCT01714492 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Tennessee, Knoxville, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Knee Replacement Arthroplasty appearing as the primary indexed condition, and to 1 intervention — of which Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01714492 reports 3 study locations spanning 2 distinct geographic areas — top geographies include Tennessee, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01714492 about?

NCT01714492 is a clinical study titled "Mechanics Analysis of Patients Having a Sigma Mobile Bearing TKA". 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...

What is the current status of trial NCT01714492?

This trial is currently completed. The enrollment target is 8 participants. The study started on 2012-04. Estimated completion is 2012-11.

What conditions does trial NCT01714492 study?

This clinical trial studies the following conditions: Knee Replacement Arthroplasty, Knee Prosthesis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01714492?

The interventions under investigation include: Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01714492?

This trial is sponsored by The University of Tennessee, Knoxville, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01714492 being conducted?

This trial has 3 study locations across Colorado, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial