Knee ProsthesisSigma MB TKANCT01714492

Mechanics Analysis of Patients Having a Sigma Mobile Bearing TKA

An observational study of Knee Prosthesis and Knee Replacement Arthroplasty, run by The University of Tennessee, Knoxville at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 85 years
Conditions the study is for: Knee Prosthesis, Knee Replacement Arthroplasty
What is being tested?: Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly
Type of treatment: Medical device
How many people: 8 participants
Where: 3 sitesUnited States
Study dates: Apr 2012to Nov 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients are eight mobile bearing subjects that were implanted over 10 years ago with a custom polyethylene insert that has four beads rigidly inserted into the polyethylene component.

Who may be able to join

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.

Who cannot join

Pregnant females
Those not willing to sign the IC and HIPAA forms

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Porter Adventist Hospital, Colorado Joint Replacement
Denver, Colorado, 80210
Perkins Hall, The University of Tennessee
Knoxville, Tennessee, 37996
Science and Engineering Research Facility, The University of Tennessee
Knoxville, Tennessee, 37996

Other trials in United States

About this study

Official title: In Vivo 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 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.

Read the 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.

Conditions: Knee Prosthesis, Knee Replacement Arthroplasty
Being tested: Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly
Keywords: Total Knee Arthroplasty (TKA), in vivo mechanics, kinematics, fluoroscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01714492
Study group	Role	What they receive
Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly		subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads Receives: Device: Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 10 yrs post-operative
Femoral Axial Rotation With Respect to the Tibia During Deep Knee Bend Activity
Measured: 10 yrs post-operative
Range of Motion During Flexion of Deep Knee Bend Activity
Measured: 10 yrs post-operative

Secondary outcomes (3)

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.
Measured: 10 yrs post-operative
Condyle Contact Area at Maximum Flexion During Deep Knee Bend Activity
Measured: 10 yrs post-operative
Condyle Contact Stress at Maximum Flexion During Deep Knee Bend Activity
Measured: 10 yrs post-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012Nov 2012

First posted26 Oct 2012 (estimated)
Study startApr 2012
Primary completionNov 2012
Study completionNov 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Knee ProsthesisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01714492
Sponsor's protocol ID: 11019
Other IDs: R01 1373 424
Acronym: Sigma MB TKA
Status last verified: Oct 2019
First submitted: 23 Oct 2012
Last updated: 10 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Knee Prosthesis trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: In Vivo Mechanics Analysis of Patients Having a Sigma Mobile Bearing TKA
ClinicalTrials.gov ID: NCT01714492
Acronym / sponsor ID: Sigma MB TKA / 11019
Conditions: Knee Prosthesis, Knee Replacement Arthroplasty
Keywords: Total Knee Arthroplasty (TKA), in vivo mechanics, kinematics, fluoroscopy
Study type: Observational
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: The University of Tennessee, KnoxvilleUniversity, hospital or other
Collaborators: DePuy Orthopaedics
Study start: Apr 2012
Primary completion: Nov 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 26 Oct 2012 (estimated)
Results: Posted 17 Feb 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly	–	Device: Sigma Posterior Stabilizing Rotating Platform TKA Beaded Polysubjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads

Who may qualify

Ages: 40 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients are eight mobile bearing subjects that were implanted over 10 years ago with a custom polyethylene insert that has four beads rigidly inserted into the polyethylene component.

Key inclusion criteria (7 listed)

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

Key exclusion criteria (2 listed)

Pregnant females
Those not willing to sign the IC and HIPAA forms

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sigma Posterior Stabilizing Rotating Platform TKA Beaded PolySigma PS RP TKA including a polyethylene insert with 4 beads	Device	Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly

Primary outcome

In Vivo Linear Knee Kinematics From Fluoroscopy Evaluation During Deep Knee Bend Activity
Time frame: 10 yrs post-operative
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.
Femoral Axial Rotation With Respect to the Tibia During Deep Knee Bend Activity
Time frame: 10 yrs post-operative
Range of Motion During Flexion of Deep Knee Bend Activity
Time frame: 10 yrs post-operative

3 secondary outcomes

In Vivo Knee Force Values From Fluoroscopy Evaluation During Deep Knee Bend Activity
Time frame: 10 yrs post-operative
Condyle Contact Area at Maximum Flexion During Deep Knee Bend Activity
Time frame: 10 yrs post-operative
Condyle Contact Stress at Maximum Flexion During Deep Knee Bend Activity
Time frame: 10 yrs post-operative

Results and safety

Results posted to the registry on 17 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly	8	8

Primary outcome: In Vivo Linear Knee Kinematics From Fluoroscopy Evaluation During Deep Knee Bend Activity

Time frame: 10 yrs post-operative. Mean (Standard Deviation). Unit: mm

Measure	In Vivo Knee Kinematics From Fluoroscopy Evaluation During Dee n = 8
Lateral Anterior Posterior Deep Knee Bend	-4.1 (2.4)
Medial Anterior Posterior Deep Knee Bend	1.2 (2.8)

Population analysed: Subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.

Primary outcome: Femoral Axial Rotation With Respect to the Tibia During Deep Knee Bend Activity

Time frame: 10 yrs post-operative. Mean (Standard Deviation). Unit: degrees

Measure	In Vivo Knee Kinematics From Fluoroscopy Evaluation During Dee n = 8
Value	6.1 (5.8)

Primary outcome: Range of Motion During Flexion of Deep Knee Bend Activity

Time frame: 10 yrs post-operative. Mean (Standard Deviation). Unit: degrees

Measure	In Vivo Knee Kinematics From Fluoroscopy Evaluation During Dee n = 8
Value	103 (11.2)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly	0 of 8 (0%)	0 of 8 (0%)	Not reported

Limitations and caveats (from the sponsor): Small study population; only one specific type of mobile bearing implant was analyzed; no definitive way to quantitatively measure level of wear on various implants to determine if there was any influence on the kinematic performance.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Knee Prosthesis

Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis
Active, not recruiting
Survivorship of Attune Primary Total Knee Prosthesis
Noninflammatory Degenerative Joint Disease
Recruiting
Sola2 AMF Knee System Added to Surgery and Antibiotics in Adults With Knee Implant Infection
Prosthetic Joint Infection of Knee
Enrolling by invitation
Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients Using the Avior Knee
Transfemoral Amputees
Recruiting
Bio Leg: Advancing Mobility (BAM)
Amputation of Lower Limb Above Knee, Amputee

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Richard D Komistek, Ph. D. principal investigator

The University of Tennessee

Dennis A Douglas, MD principal investigator

Colorado Joint Replacement

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Knee Prosthesis and Knee Replacement Arthroplasty, run by The University of Tennessee, Knoxville at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In Vivo Linear Knee Kinematics From Fluoroscopy Evaluation During Deep Knee Bend Activity (time frame: 10 yrs post-operative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01714492.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2019.