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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01714492
Other study ID # 11019
Secondary ID R01 1373 424
Status Completed
Phase
First received
Last updated
Start date April 2012
Est. completion date November 2012

Study information

Verified date October 2019
Source The University of Tennessee, Knoxville
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender All
Age group 40 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly
Sigma PS RP TKA including a polyethylene insert with 4 beads

Locations

Country Name City State
United States Porter Adventist Hospital, Colorado Joint Replacement Denver Colorado
United States Perkins Hall, The University of Tennessee Knoxville Tennessee
United States Science and Engineering Research Facility, The University of Tennessee Knoxville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
The University of Tennessee, Knoxville DePuy Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary In Vivo Linear Knee Kinematics From Fluoroscopy Evaluation During Deep Knee Bend Activity The values that were reported indicate the motion of the contact point from full extension to patient's maximum flexion. Throughout flexion, if the point translated forward (anteriorly) atop the tibial tray, the number was reported as positive. If the point traveled backwards (posteriorly) atop the tibial tray, the number was reported as negative. 10 yrs post-operative
Primary Femoral Axial Rotation With Respect to the Tibia During Deep Knee Bend Activity 10 yrs post-operative
Primary Range of Motion During Flexion of Deep Knee Bend Activity 10 yrs post-operative
Secondary In Vivo Knee Force Values From Fluoroscopy Evaluation During Deep Knee Bend Activity The intended unit of measure is "times Body Weight" (or xBW), relating to a ratio. 10 yrs post-operative
Secondary Condyle Contact Area at Maximum Flexion During Deep Knee Bend Activity 10 yrs post-operative
Secondary Condyle Contact Stress at Maximum Flexion During Deep Knee Bend Activity 10 yrs post-operative
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