N/A
Completed N=8
Mechanics Analysis of Patients Having a Sigma Mobile Bearing TKA
Knee Prosthesis · Knee Replacement Arthroplasty
Source: ClinicalTrials.gov NCT01714492 ↗
Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcomePrimary: In Vivo Linear Knee Kinematics From Fluoroscopy Evaluation During Deep Knee Bend Activity — -4.1; 1.2 mm
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY In Vivo Linear Knee Kinematics From Fluoroscopy Evaluation During Deep Knee Bend Activity |
-4.1; 1.2 | — |
| PRIMARY Femoral Axial Rotation With Respect to the Tibia During Deep Knee Bend Activity |
6.1 | — |
| PRIMARY Range of Motion During Flexion of Deep Knee Bend Activity |
103 | — |
| SECONDARY In Vivo Knee Force Values From Fluoroscopy Evaluation During Deep Knee Bend Activity |
1.57; 1.39 | — |
| SECONDARY Condyle Contact Area at Maximum Flexion During Deep Knee Bend Activity |
109.16; 104.78 | — |
| SECONDARY Condyle Contact Stress at Maximum Flexion During Deep Knee Bend Activity |
10.66; 10.05 | — |
Eligibility Criteria
Inclusion Criteria
- At least six months post-operative
- Between 40-85 years of age
- Have a body weight of less than 250 lbs.
- Judged clinically successful with a AKS greater than 90
- Have the DePuy Sigma mobile bearing TKA
- Good-to-excellent post-operative passive flexion
- Must be willing to sign the IC and HIPAA forms.
Exclusion Criteria
- Pregnant females
- Those not willing to sign the IC and HIPAA forms
Data sourced from ClinicalTrials.gov (NCT01714492). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.