Arthroplasty Replacement KneePatellaNCT01290627

In Vivo Determination of 3D Patellofemoral Mechanics

An observational study of Arthroplasty Replacement Knee and Knee Prosthesis, run by The University of Tennessee, Knoxville at 4 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 20 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Arthroplasty Replacement Knee, Knee Prosthesis
What is being tested?: Subjects implanted with DePuy LCS PS RP TKA and Subjects implanted with DePuy Sigma PS RP TKA
Type of treatment: Medical device
How many people: 30 participants
Where: 4 sitesUnited States
Study dates: Feb 2011to Sep 2011
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 20 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Subjects recruited from patients chosen from practice of Dr.'s Dennis and Haas at Colorado Joint Replacement for implanted knee, having either one of the two kinds of implants specified.

Who may be able to join

Patients must be at least six months post-operative.
Potential subjects will have a body weight of less than 250 lbs.
Candidates must have an AKS score >70 post-operatively.
Patients must have passive flexion of at least 100.
Implanted group must have either an LCS PS RP TKA, having an anatomical patella, or Sigma PS RP TKA; or normal knee group must have normal knee.
Must be willing to sign both Informed Consent and HIPAA forms.

Who cannot join

Pregnant females.
Subjects not meeting study requirements.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

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

Other trials in United States

About this study

This study will analyze the tibio-femoral and patellofemoral (motion) and mechanics (forces) of participants having a normal knee or a total knee arthroplasty (TKA) using one or two different (TKA) devices Low Contract Stress (LCS) Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA). All knees will be analyzed using an image matching technique that will convert a two-dimensional (2D) fluoroscopic image into a three-dimensional (3D) image. In conjunction with the fluoroscopic analysis, electromyography (EMG) data, and ground reaction force (GRF) data will all be allow for a complete analysis of the knee joints. These results will help the orthopaedic community better understand knee motion so they can improve testing on existing implants and develop future implants that will further enhance patients' lives.

Conditions: Arthroplasty Replacement Knee, Knee Prosthesis
Being tested: Subjects implanted with DePuy LCS PS RP TKA, Subjects implanted with DePuy Sigma PS RP TKA

What participants receive

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

Subjects implanted with DePuy LCS PS RP TKADevice
Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
Subjects implanted with DePuy Sigma PS RP TKADevice
Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)

Study groups in NCT01290627
Study group	Role	What they receive
Knee Prosthesis LCS PS RP TKA		Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA) Receives: Device: Subjects implanted with DePuy LCS PS RP TKA
Knee Prosthesis Sigma PS RP TKA		Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA) Receives: Device: Subjects implanted with DePuy Sigma PS RP TKA
Control		Subjects with normal knees

What is being measured

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

Patella Flexion With Respect to Femur
Full extension to maximum flexion. Degrees of flexion analyzed for participants with and without implants.
Measured: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
Patella Rotation With Respect to Femur
Patellar rotation from full extension to maximum flexion for subjects with and without implants. A positive measurement of patellar rotation refers to positive flexion of the patella about the medial-lateral axis, where the patella component rotates so that the top of the patella rotates toward the femur and the bottom rotates away. Conversely, a negative measurement refers to negative flexion of the patella about this axis, where the patellar component rotates so that the top of the patella moves away from the femur and the bottom moves towards.
Measured: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
Patella Tilt With Respect to Femur
full extension to maximum flexion for participants with and without implants.
Measured: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
Normalized Medial Patella Contact Point Translation
full extension to maximum flexion for participants with and without implants. Position of the patellar contact point was determined by locating the closest point to the femur on the patella throughout flexion. There are 2 patello-femoral contact points: a point on the medial aspect of the patella and a point on the lateral aspect of the patella. Throughout flexion, the medial contact point generally moves closer to the top of the patella (hence the positive value for the results). The translation of this contact point is normalized to report a ratio between -1 and 1. In other words, the distance the point has traveled compared to the total height of the patella. For example, if the patella is 8 cm in height and the point travels approximately 2 cm upwards during flexion, the value would be reported as +2/8 = +0.25. Definition of normalized: "multiply (a series, function, or item of data) by a factor that makes the norm or some associated quantity such as an integral equal
Measured: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
Normalized Lateral Patella Contact Point Translation
full extension to maximum flexion for participants with and without implants. Position of patellar contact point was determined by locating closest point to femur on patella throughout flexion. There are 2 patello-femoral contact points: 1 point on the medial aspect of the patella and 1 point on the lateral aspect of the patella. Throughout flexion, lateral contact point generally moves closer to the top of the patella (hence, the positive value for the results). The translation of this contact point is normalized to report a ratio between -1 and 1. The distance the point has traveled compared to the total height of the patella. For example, if the patella is 8 cm in height and the point travels approximately 2 cm upwards during flexion, the value would be reported as +2/8 = +0.25. Definition of normalized: "multiply (a series, function, or item of data) by a factor that makes the norm or some associated quantity such as an integral equal to a desired value (usually 1)."
Measured: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.

Timeline

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

Feb 2011Sep 2011

First posted7 Feb 2011 (estimated)
Study startFeb 2011
Primary completionSep 2011
Study completionSep 2011

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 Arthroplasty Replacement KneeStudies 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: Case only
Time perspective: Retrospective
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01290627
Sponsor's protocol ID: 10035/IIS-000126
Other IDs: R011373372
Acronym: Patella
Status last verified: Oct 2019
First submitted: 3 Feb 2011
Last updated: 29 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 Arthroplasty Replacement Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: In Vivo Determination of 3D Patellofemoral Mechanics
ClinicalTrials.gov ID: NCT01290627
Acronym / sponsor ID: Patella / 10035/IIS-000126
Conditions: Arthroplasty Replacement Knee, Knee Prosthesis
Study type: Observational
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: The University of Tennessee, KnoxvilleUniversity, hospital or other
Collaborators: DePuy Orthopaedics
Study start: Feb 2011
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 7 Feb 2011 (estimated)
Results: Posted 13 Jan 2014

Clinical summary

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

Study design

Observational model: Case only
Time perspective: Retrospective
Number of arms: 3

Arm	Type	Receives
Knee Prosthesis LCS PS RP TKA	–	Device: Subjects implanted with DePuy LCS PS RP TKASubjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
Knee Prosthesis Sigma PS RP TKA	–	Device: Subjects implanted with DePuy Sigma PS RP TKASubjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
Control	–	–Subjects with normal knees

Who may qualify

Ages: 20 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Subjects recruited from patients chosen from practice of Dr.'s Dennis and Haas at Colorado Joint Replacement for implanted knee, having either one of the two kinds of implants specified.

Key inclusion criteria (6 listed)

Patients must be at least six months post-operative.
Potential subjects will have a body weight of less than 250 lbs.
Candidates must have an AKS score >70 post-operatively.
Patients must have passive flexion of at least 100.
Implanted group must have either an LCS PS RP TKA, having an anatomical patella, or Sigma PS RP TKA; or normal knee group must have normal knee.

Key exclusion criteria (2 listed)

Pregnant females.
Subjects not meeting study requirements.

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
Subjects implanted with DePuy LCS PS RP TKASubjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)	Device	Knee Prosthesis LCS PS RP TKA
Subjects implanted with DePuy Sigma PS RP TKASubjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)	Device	Knee Prosthesis Sigma PS RP TKA

Primary outcome

Patella Flexion With Respect to Femur
Time frame: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
Full extension to maximum flexion. Degrees of flexion analyzed for participants with and without implants.
Patella Rotation With Respect to Femur
Time frame: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
Patellar rotation from full extension to maximum flexion for subjects with and without implants. A positive measurement of patellar rotation refers to positive flexion of the patella about the medial-lateral axis, where the patella component rotates so that the top of the patella rotates toward the femur and the bottom rotates away. Conversely, a negative measurement refers to negative flexion of the patella about this axis, where the patellar component rotates so that the top of the patella moves away from the femur and the bottom moves towards.
Patella Tilt With Respect to Femur
Time frame: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
full extension to maximum flexion for participants with and without implants.
Normalized Medial Patella Contact Point Translation
Time frame: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
full extension to maximum flexion for participants with and without implants. Position of the patellar contact point was determined by locating the closest point to the femur on the patella throughout flexion. There are 2 patello-femoral contact points: a point on the medial aspect of the patella and a point on the lateral aspect of the patella. Throughout flexion, the medial contact point generally moves closer to the top of the patella (hence the positive value for the results). The translation of this contact point is normalized to report a ratio between -1 and 1. In other words, the distance the point has traveled compared to the total height of the patella. For example, if the patella is 8 cm in height and the point travels approximately 2 cm upwards during flexion, the value would be reported as +2/8 = +0.25. Definition of normalized: "multiply (a series, function, or item of data) by a factor that makes the norm or some associated quantity such as an integral equal
Normalized Lateral Patella Contact Point Translation
Time frame: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.
full extension to maximum flexion for participants with and without implants. Position of patellar contact point was determined by locating closest point to femur on patella throughout flexion. There are 2 patello-femoral contact points: 1 point on the medial aspect of the patella and 1 point on the lateral aspect of the patella. Throughout flexion, lateral contact point generally moves closer to the top of the patella (hence, the positive value for the results). The translation of this contact point is normalized to report a ratio between -1 and 1. The distance the point has traveled compared to the total height of the patella. For example, if the patella is 8 cm in height and the point travels approximately 2 cm upwards during flexion, the value would be reported as +2/8 = +0.25. Definition of normalized: "multiply (a series, function, or item of data) by a factor that makes the norm or some associated quantity such as an integral equal to a desired value (usually 1)."

Results and safety

Results posted to the registry on 13 Jan 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
Knee Prosthesis LCS PS RP TKA	10	10
Knee Prosthesis Sigma PS RP TKA	10	10
Control	10	10

Primary outcome: Patella Flexion With Respect to Femur

Time frame: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.. Mean (Standard Deviation). Unit: degrees

Measure	Knee Prosthesis LCS PS RP TKA n = 10	Knee Prosthesis Sigma PS RP TKA n = 10	Control n = 10
Value	80.0 (13.6)	83.4 (12.9)	93.7 (12.9)

Population analysed: Unit analyzed is an orthopaedic implant and subjects with normal knees do not have orthopaedic implants.

Primary outcome: Patella Rotation With Respect to Femur

Time frame: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.. Mean (Standard Deviation). Unit: degrees

Measure	Knee Prosthesis LCS PS RP TKA n = 10	Knee Prosthesis Sigma PS RP TKA n = 10	Control n = 10
Value	.5 (5.0)	-.06 (3.1)	-1.6 (6.1)

Population analysed: Unit analyzed is an orthopaedic implant and subjects with normal knees do not have orthopaedic implants.

Primary outcome: Patella Tilt With Respect to Femur

Time frame: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.. Mean (Standard Deviation). Unit: degrees

Measure	Knee Prosthesis LCS PS RP TKA n = 10	Knee Prosthesis Sigma PS RP TKA n = 10	Control n = 10
Value	4.2 (5.1)	2.6 (6.4)	5.3 (5.9)

Population analysed: Unit analyzed is an orthopaedic implant and subjects with normal knees do not have orthopaedic implants.

Primary outcome: Normalized Medial Patella Contact Point Translation

Time frame: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.. Mean (Standard Deviation). Unit: ratio of patella height

Measure	Knee Prosthesis LCS PS RP TKA n = 10	Knee Prosthesis Sigma PS RP TKA n = 10	Control n = 10
Value	.34 (.18)	.12 (.17)	.40 (.41)

Population analysed: Unit analyzed is an orthopaedic implant and subjects with normal knees do not have orthopaedic implants.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Knee Prosthesis LCS PS RP TKA	0 of 10 (0%)	0 of 10 (0%)	Not reported
Knee Prosthesis Sigma PS RP TKA	0 of 10 (0%)	0 of 10 (0%)	Not reported
Control	0 of 10 (0%)	0 of 10 (0%)	Not reported

Limitations and caveats (from the sponsor): No adverse effects, events or unexpected risks occurred The sample size per group was small Age of the TKA groups were matched, the age of the normal subjects were not Cartilage thickness for normals had to be assumed as MRIs could not be obtained

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

Douglas Dennis, MD principal investigator

Colorado Joint Replacement, Porter Adventist Hosp

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

Questions about this trial

What is this clinical trial studying?

An observational study of Arthroplasty Replacement Knee and Knee Prosthesis, run by The University of Tennessee, Knoxville at 4 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 6 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 29 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 4 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 13 Jan 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?

Patella Flexion With Respect to Femur (time frame: Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.). The study lists 5 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 NCT01290627.

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 29 Oct 2019.