OsteoarthritisPhase 4NCT00764673

The 3DKnee™ System: A Post-Market Study

A Phase 4 study testing 3DKnee in people with Osteoarthritis and Rheumatoid Arthritis, run by Encore Medical, L.P. at 1 site 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

The purpose of this study is to evaluate the survivorship and efficacy of the Encore 3DKnee™ system in a group of patients who will receive the 3DKnee™ as a primary (first) orthopedic implant in the knee. Each knee will be designated as a separate subject and followed for a period of 2 years. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Osteoarthritis, Rheumatoid Arthritis, Post Traumatic Arthritis
What is being tested?: 3DKnee
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 71 participants
Where: 1 siteUnited States
Study dates: Oct 2006to Oct 2010
Phase: Phase 4
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

This must be a primary knee replacement on this knee.
Have knee joint disease related to one or more of the following
degenerative joint disease, including osteoarthritis or traumatic arthritis
Avascular necrosis of the femoral condyles
Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
Moderate valgus, varus, or flexion deformities

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Rheumatoid arthritis
Patient is likely to be available for evaluation for the duration of the study
Able and willing to sign the informed consent and follow study procedures
Patient is not pregnant
Patient must be over 18 years of age

Who cannot join

If there has been a total knee replacement on this knee in the past (no revisions allowed in study)
Infection, or history of infection, acute or chronic, local or systemic
Alcoholism or other addictions
Muscular, neurological or vascular deficiencies which compromise the affected extremity
Obesity
Insufficient bone quality

Show all 13Show fewer

Loss of ligamentous structures
High levels of physical activity
Materials sensitivity
Prisoner
Mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements
Patient is pregnant
Is younger than 18 years of age

Trial locations and contacts

1 site in 1 country.

United States1 site

St. Peter's Bone & Joint Surgery
City of Saint Peters, Missouri, 63376

Other trials in United States

About this study

Conditions: Osteoarthritis, Rheumatoid Arthritis, Post Traumatic Arthritis, Varus Deformity, Avascular Necrosis
Being tested: 3DKnee
Medical subject headings: Osteoarthritis, Arthritis, Rheumatoid, Osteonecrosis

What participants receive

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

3DKneeDevice
Subjects with knee osteoarthritis and willing to participate in the study

Study groups in NCT00764673
Study group	Role	What they receive
Primary	Other	Post market study Receives: Device: 3DKnee

What is being measured

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

Knee Society Score Evaluation
The Knee Society Score includes a knee rating and function score. This evaluation covers the knee rating score with three main parameters of pain, stability and range of motion and that flexion contracture, extension lag and misalignment should be dealt with as deductions. Thus, 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability. 50 points are allotted for pain, 25 for stability, and 25 for range of motion. Grading for KS Score: Excellent (90-100), Good (80-90), Fair (70-79) and Poor (<70).
Measured: 2 year
Knee Society Function Score
The Knee Society Score includes a knee rating and function score. Patient function considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score, which is also 100, is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. Walking ability is expressed in blocks (approximately 100 meters). Stair climbing is considered normal if the patient can ascend and descend stairs without holding a railing. A score of > or = to 60 on the function score is considered success.
Measured: 2-year
Number of Participants With >2mm Wide at the Bone/Cement Interface or a >3 Degree or >3 mm Migration (Shift) of the Component.
Radiographic failure is defined as a complete radiolucent line > 2mm wide at the bone/cement interface or a >3 degree or >3 mm migration (shift) of the component.
Measured: 2-year
Safety Assessment
Number of device related adverse events and device failures at the 2 year time frame.
Measured: 2-year

Secondary outcomes (1)

Oxford Knee Score
Questionnaire on the perceptions of patients about a total knee replacement. Score between 0 and 48 where: 0 to 19 may indicate severe knee arthritis, 20 to 29 may indicate moderate to severe knee arthritis, 30 to 39 may indicate mild to moderate knee arthritis and 40 to 48 may indicate satisfactory joint function.
Measured: 2-year

Timeline

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

Oct 2006Oct 2010

First posted2 Oct 2008 (estimated)
Study startOct 2006
Primary completionOct 2010
Study completionOct 2010

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 OsteoarthritisStudies 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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00764673
Sponsor's protocol ID: PS - 703
Status last verified: Feb 2011
First submitted: 30 Sep 2008
Last updated: 2 Mar 2011
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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Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The 3DKnee™ System: A Post-Market Study
ClinicalTrials.gov ID: NCT00764673
Acronym / sponsor ID: PS - 703
Conditions: Osteoarthritis, Rheumatoid Arthritis, Post Traumatic Arthritis, Varus Deformity, Avascular Necrosis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: Encore Medical, L.P.Industry (pharma, biotech, devices)
Study start: Oct 2006
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 2 Oct 2008 (estimated)
Results: Posted 2 Mar 2011

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Primary	Other	Device: 3DKneePost market study

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

This must be a primary knee replacement on this knee.
Have knee joint disease related to one or more of the following
Patient is likely to be available for evaluation for the duration of the study
Able and willing to sign the informed consent and follow study procedures
Patient is not pregnant

Key exclusion criteria (13 listed)

If there has been a total knee replacement on this knee in the past (no revisions allowed in study)
Infection, or history of infection, acute or chronic, local or systemic
Alcoholism or other addictions
Muscular, neurological or vascular deficiencies which compromise the affected extremity
Obesity

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
3DKneeSubjects with knee osteoarthritis and willing to participate in the study	Device	Primary

Primary outcome

Knee Society Score Evaluation
Time frame: 2 year
The Knee Society Score includes a knee rating and function score. This evaluation covers the knee rating score with three main parameters of pain, stability and range of motion and that flexion contracture, extension lag and misalignment should be dealt with as deductions. Thus, 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability. 50 points are allotted for pain, 25 for stability, and 25 for range of motion. Grading for KS Score: Excellent (90-100), Good (80-90), Fair (70-79) and Poor (<70).
Knee Society Function Score
Time frame: 2-year
The Knee Society Score includes a knee rating and function score. Patient function considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score, which is also 100, is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. Walking ability is expressed in blocks (approximately 100 meters). Stair climbing is considered normal if the patient can ascend and descend stairs without holding a railing. A score of > or = to 60 on the function score is considered success.
Number of Participants With >2mm Wide at the Bone/Cement Interface or a >3 Degree or >3 mm Migration (Shift) of the Component.
Time frame: 2-year
Radiographic failure is defined as a complete radiolucent line > 2mm wide at the bone/cement interface or a >3 degree or >3 mm migration (shift) of the component.
Safety Assessment
Time frame: 2-year
Number of device related adverse events and device failures at the 2 year time frame.

1 secondary outcome

Oxford Knee Score
Time frame: 2-year

Results and safety

Results posted to the registry on 2 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Primary 3DKnee Implant	71	59

Primary outcome: Knee Society Score Evaluation

Time frame: 2 year. Mean (Standard Deviation). Unit: Average Knee Rating Score

Measure	Primary 3DKnee Implant n = 59
Value	82.9 (25.7)

Population analysed: The number of subjects who completed their 2 year visit.

Primary outcome: Knee Society Function Score

Time frame: 2-year. Mean (Standard Deviation). Unit: Average Knee Function Score

Measure	Primary 3DKnee Implant n = 54
Value	76.6 (20.0)

Population analysed: The number of subjects who completed their 2 year visit and had available data to collect for this evaluation.

Primary outcome: Number of Participants With >2mm Wide at the Bone/Cement Interface or a >3 Degree or >3 mm Migration (Shift) of the Component.

Time frame: 2-year. Number. Unit: participants

Measure	Primary 3DKnee Implant n = 59
Value	0

Population analysed: The number of subjects who came in for a 2 year visit and completed the x-ray portion of the evaluation.

Primary outcome: Safety Assessment

Time frame: 2-year. Number. Unit: Events

Measure	Primary 3DKnee Implant n = 71
Revisions of device	2
Number of device related adverse events	18
Total number of operative site events	40

Population analysed: All subjects in the study were evaluated for adverse events.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Primary 3DKnee Implant	0 of 71 (0%)	62 of 71 (87.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Sponsor Company home pageLink provided by the sponsor.

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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.

John McAllister, M.D. principal investigator

St. Peter's Bone and Joint Surgery

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 3DKnee in people with Osteoarthritis and Rheumatoid Arthritis, run by Encore Medical, L.P. at 1 site 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 11 inclusion and 13 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 2 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Mar 2011). 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?

Knee Society Score Evaluation (time frame: 2 year). The study lists 4 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 NCT00764673.

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 2 Mar 2011.