Knee ProsthesisNCT01864434

In Vivo Kinematics Comparison of Stryker or Zimmer Total Knee Arthroplasty

An observational study of 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.

Trial summary

This study will compare the kinematics data collected from patients with implants created by different manufacturers to see which of these implants provides a more normal-like kinematic pattern compared to the normal knee. Read more about this study

Who is it for?: Ages 40 to 70 years
Conditions the study is for: Knee Prosthesis
What is being tested?: Stryker posterior cruciat retaining (PCR) total knee arthroplasty (TKA) and Zimmer PCR TKA
Type of treatment: Medical device
How many people: 50 participants
Where: 4 sitesUnited States
Study dates: Jun 2013to Nov 2014
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Participants will be patients of Dr. Harold E. Cates of Tennessee Orthopaedic Clinics and must have been implanted with either a Stryker Triathlon CR TKA or Zimmer PCR TKA

Who may be able to join

Must be at least 3 months post-operative with no other surgical procedures conducted within the past 6 months
Must have body weight of less than 250 lbs
Must have Body Mass Index of less than 38
Must be judged clinically successful with a Knee Society Score >90
Must have 100% post-operative passive flexion with no ligamentous laxity or pain
Must be able to walk on level ground without aid of any kind

Show all 9Show fewer

Must be able to ascend and descend a ramp with a 10 degree incline with no assistance
Must be willing to sign both Informed Consent and HIPAA forms
Must be between 160 cm (5'3) and 193 cm (6'4) tall

Who cannot join

Pregnant or potentially pregnant females
Unwilling to sign Informed Consent or HIPAA forms

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Tennessee Orthopaedic Clinic, Tennessee Orthopaedic Foundation for Education & Research
Knoxville, Tennessee, 37923
Dougherty Engineering Building, Room M007
Knoxville, Tennessee, 37996
Perkins Hall, The University of Tennessee
Knoxville, Tennessee, 37996
Science and Engineering Research Facility
Knoxville, Tennessee, 37996

Other trials in United States

About this study

Official title: In Vivo Comparison of Kinematics for Patients Implanted With Either a Stryker or a Zimmer Posterior Cruciate Retaining Total Knee Arthroplasty

Read the detailed description

A better understanding of knee joint kinematics is important to explain premature polyethylene wear failures within knee implants and to help design a prosthesis that most closely approximates the normal knee. Therefore, the objectives for this study are to compare the in vivo kinematic patterns for subjects implanted with either a Stryker Triathlon Posterior Cruciate Retaining (PCR) Total Knee Arthroplasty (TKA) or Zimmer NexGen PCR TKA design to determine if there are any kinematic differences between these TKA designs. Each subject will be asked to undergo a fluoroscopic evaluation while performing weight-bearing activities under surveillance using the University of Tennessee's new mobile tracking fluoroscopic unit while performing deep knee bend and ramp up and ramp down activities. The mobile fluoroscopy unit is approved for use by the State of Tennessee on a study-by-study basis after IRB approval is obtained for each study.

Conditions: Knee Prosthesis
Being tested: Stryker posterior cruciat retaining (PCR) total knee arthroplasty (TKA), Zimmer PCR TKA
Keywords: Knee Prosthesis, Total Knee Arthroplasty, Cruciate Retaining, Posterior Cruciate Retaining

What participants receive

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

Stryker posterior cruciat retaining (PCR) total knee arthroplasty (TKA)Device
Also called Triathlon PCR TKA
The fluoroscopy procedure itself is used as a means of data collection and is not the intervention under investigation; therefore, the study is observational and not interventional.
Zimmer PCR TKADevice
Also called Zimmer NexGen PCR TKA
The fluoroscopy procedure itself is used as a means of data collection and is not the intervention under investigation; therefore, the study is observational and not interventional.

Study groups in NCT01864434
Study group	Role	What they receive
Patients with a Stryker Triathlon CR TKA		Patients implanted with a Stryker Triathlon Posterior Cruciate Retaining Total Knee Arthroplasty. Receives: Device: Stryker posterior cruciat retaining (PCR) total knee arthroplasty (TKA)
Patients with a Zimmer PCR TKA		Patients implanted with a Zimmer NexGen Posterior Cruciate Retaining Total Knee Arthroplasty. Receives: Device: Zimmer PCR TKA

What is being measured

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

Kinematics - Deep Knee Bend Activity
Lateral Anterior Posterior (LAP) and Medial Anterior Posterior (MAP) translations, and Axial Rotation (AR) and maximum flexion of medial femoral condyles during deep knee bend (DKB) activity
Measured: 3 months post-operative
Kinematics - Ramp up Activity
Lateral Anterior Posterior (LAP) [during 3 moments - 0-33%, 33-66% and 66-100%] and Medial Anterior Posterior (MAP) [during 3 moments - 0-33%, 33-66% and 66-100%] translations, and Axial Rotation (AR) [during 3 moments - 0-33%, 33-66% and 66-100%] of medial femoral condyles during ramp up activity
Measured: 3 months post-operative
Kinematics - Ramp Down Activity
Lateral Anterior Posterior (LAP) [during 3 moments - 0-33%, 33-66% and 66-100%] and Medial Anterior Posterior (MAP) [during 3 moments - 0-33%, 33-66% and 66-100%] translations, and Axial Rotation (AR) [during 3 moments - 0-33%, 33-66% and 66-100%] of medial femoral condyles during ramp down activity
Measured: 3 months post-operative

Timeline

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

Jun 2013Nov 2014

First posted29 May 2013 (estimated)
Study startJun 2013
Primary completionNov 2014
Study completionNov 2014

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: Case-control
Time perspective: Retrospective
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01864434
Sponsor's protocol ID: 130180/2012017
Other IDs: R011373454
Status last verified: Oct 2019
First submitted: 16 May 2013
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 Comparison of Kinematics for Patients Implanted With Either a Stryker or a Zimmer Posterior Cruciate Retaining Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT01864434
Acronym / sponsor ID: 130180/2012017
Conditions: Knee Prosthesis
Keywords: Knee Prosthesis, Total Knee Arthroplasty, Cruciate Retaining, Posterior Cruciate Retaining
Study type: Observational
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: The University of Tennessee, KnoxvilleUniversity, hospital or other
Collaborators: Stryker Orthopaedics
Study start: Jun 2013
Primary completion: Nov 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 29 May 2013 (estimated)
Results: Posted 24 Dec 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

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Patients with a Stryker Triathlon CR TKA	–	Device: Stryker posterior cruciat retaining (PCR) total knee arthroplasty (TKA)Patients implanted with a Stryker Triathlon Posterior Cruciate Retaining Total Knee Arthroplasty.
Patients with a Zimmer PCR TKA	–	Device: Zimmer PCR TKAPatients implanted with a Zimmer NexGen Posterior Cruciate Retaining Total Knee Arthroplasty.

Who may qualify

Ages: 40 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants will be patients of Dr. Harold E. Cates of Tennessee Orthopaedic Clinics and must have been implanted with either a Stryker Triathlon CR TKA or Zimmer PCR TKA

Key inclusion criteria (9 listed)

Must be at least 3 months post-operative with no other surgical procedures conducted within the past 6 months
Must have body weight of less than 250 lbs
Must have Body Mass Index of less than 38
Must be judged clinically successful with a Knee Society Score >90
Must have 100% post-operative passive flexion with no ligamentous laxity or pain

Key exclusion criteria (2 listed)

Pregnant or potentially pregnant females
Unwilling to sign Informed Consent or 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
Stryker posterior cruciat retaining (PCR) total knee arthroplasty (TKA)Also: Triathlon PCR TKAThe fluoroscopy procedure itself is used as a means of data collection and is not the intervention under investigation; therefore, the study is observational and not interventional.	Device	Patients with a Stryker Triathlon CR TKA
Zimmer PCR TKAAlso: Zimmer NexGen PCR TKAThe fluoroscopy procedure itself is used as a means of data collection and is not the intervention under investigation; therefore, the study is observational and not interventional.	Device	Patients with a Zimmer PCR TKA

Primary outcome

Kinematics - Deep Knee Bend Activity
Time frame: 3 months post-operative
Lateral Anterior Posterior (LAP) and Medial Anterior Posterior (MAP) translations, and Axial Rotation (AR) and maximum flexion of medial femoral condyles during deep knee bend (DKB) activity
Kinematics - Ramp up Activity
Time frame: 3 months post-operative
Lateral Anterior Posterior (LAP) [during 3 moments - 0-33%, 33-66% and 66-100%] and Medial Anterior Posterior (MAP) [during 3 moments - 0-33%, 33-66% and 66-100%] translations, and Axial Rotation (AR) [during 3 moments - 0-33%, 33-66% and 66-100%] of medial femoral condyles during ramp up activity
Kinematics - Ramp Down Activity
Time frame: 3 months post-operative
Lateral Anterior Posterior (LAP) [during 3 moments - 0-33%, 33-66% and 66-100%] and Medial Anterior Posterior (MAP) [during 3 moments - 0-33%, 33-66% and 66-100%] translations, and Axial Rotation (AR) [during 3 moments - 0-33%, 33-66% and 66-100%] of medial femoral condyles during ramp down activity

Results and safety

Results posted to the registry on 24 Dec 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
Patients With a Stryker Triathlon CR TKA	25	25
Patients With a Zimmer PCR TKA	25	25

Primary outcome: Kinematics - Deep Knee Bend Activity

Time frame: 3 months post-operative. Mean (Standard Deviation). Unit: mm

Measure	Patients With a Stryker Triathlon CR TKA n = 25	Patients With a Zimmer PCR TKA n = 25
Lateral Anterior Posterior Deep Knee Bend	-0.43 (3.43)	-1.00 (3.23)
Medial Anterior Posterior Deep Knee Bend	3.51 (2.68)	-0.42 (2.20)
Axial Rotation Deep Knee Bend	5.20 (3.93)	0.75 (5.12)
Maximum Flexion Deep knee bend	107.80 (8.50)	107.20 (11)

Primary outcome: Kinematics - Ramp up Activity

Time frame: 3 months post-operative. Mean (Standard Deviation). Unit: mm

Measure	Patients With a Stryker Triathlon CR TKA n = 25	Patients With a Zimmer PCR TKA n = 25
Lateral Anterior Posterior Translation 0% to 33%	-0.31 (2.41)	0.20 (2.75)
Lateral Anterior Posterior Translation 33% to 66%	-0.94 (2.26)	-0.61 (2.42)
Lateral Anterior Posterior Translation 66% to 100%	-0.23 (2.69)	-0.07 (2.70)
Medial Anterior Posterior Translation 0% to 33%	-1.31 (3.43)	-1.88 (2.07)
Medial Anterior Posterior Translation 33% to 66%	-1.04 (3.36)	0.41 (2.16)
Medial Anterior Posterior Translation 66% to 100%	0.48 (2.35)	-0.09 (1.63)
Axial Rotation 0% to 33%	-1.33 (4.03)	-2.69 (3.99)
Axial Rotation 33% to 66%	-0.15 (3.17)	1.27 (3.42)

Primary outcome: Kinematics - Ramp Down Activity

Time frame: 3 months post-operative. Mean (Standard Deviation). Unit: mm

Measure	Patients With a Stryker Triathlon CR TKA n = 25	Patients With a Zimmer PCR TKA n = 25
Lateral Anterior Posterior Translation 0% to 33%	-0.57 (2.33)	-1.11 (2.27)
Lateral Anterior Posterior Translation 33% to 66%	-1.25 (1.86)	-0.96 (2.6)
Lateral Anterior Posterior Translation 66% to 100%	0.83 (2.56)	0.15 (2.37)
Medial Anterior Posterior Translation 0% to 33%	-0.87 (2.19)	-0.92 (1.95)
Medial Anterior Posterior Translation 33% to 66%	-.75 (2.42)	0 (1.27)
Medial Anterior Posterior Translation 66% to 100%	1.29 (2.34)	-0.31 (1.44)
Axial Rotation 0% to 33%	-0.44 (2.76)	0.24 (3.19)
Axial Rotation 33% to 66%	0.67 (3.09)	1.22 (3.97)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With a Stryker Triathlon CR TKA	0 of 25 (0%)	0 of 25 (0%)	Not reported
Patients With a Zimmer PCR TKA	0 of 25 (0%)	0 of 25 (0%)	Not reported

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.

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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.

Adrija Sharma, Ph D principal investigator

The University of Tennessee

Richard D Komistek, Ph D principal investigator

The University of Tennessee

William R Hamel, Ph D principal investigator

The University of Tennessee

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 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 9 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 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 24 Dec 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?

Kinematics - Deep Knee Bend Activity (time frame: 3 months 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 NCT01864434.

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.