Knee ArthroplastyPhase 4DeuceNCT01140815
Functional Performance of the Journey Deuce Bicompartmental Versus the Genesis II Total Knee System
A Phase 4 study testing Total Knee Replacement and Deuce in people with Knee Arthroplasty, run by Anderson Orthopaedic Research Institute at 1 site in United States.
Trial summary
The objectives of this study are to assess the safety and effectiveness of the Journey Deuce Bicompartmental Knee System at 4-6 weeks, 4 months, 1 year, and 2 years when compared to total knee replacement using the Genesis II Total Knee System. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Knee Arthroplasty
- What is being tested?
- Total Knee Replacement and Deuce
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to May 2013
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient presents with non-inflammatory degenerative joint disease of the medial and patellofemoral compartments requiring a unilateral knee replacement.
- Patient is 30 to 65 years of age, inclusive.
- Patient is willing to consent to participate in the study by signing and dating an IRB-approved consent form.
- Patient plans to be available for follow-up through 2 years postoperative.
Who cannot join
- Patient is known to have insufficient femoral or tibial bone stock resulting from conditions such as cancer, distal femoral/proximal tibial osteotomy, significant osteoporosis or metabolic bone disorders.
- Patient is immunosuppressed, has an autoimmune disorder, or an immunosuppressive disorder (i.e. chronic condition characterized by markedly inhibited ability to respond to antigenic stimuli.) Examples of such conditions include patients who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses) or patients with acquired immunodeficiency syndrome (AIDS).
- Patient has inflammatory arthritis (e.g. rheumatoid arthritis)
- Patient has BMI > 35.
- Patient has had major knee surgery in the past i.e. HTO, unicondylar knee replacement, failed fracture fixation.
- Patient has an active infection, local or systemic.
Show all 13Show fewer
- Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up (e.g.: drug or alcohol abuse, serious mental illness, or general neurological conditions such as Parkinson, Multiple sclerosis, etc.).
- Patient has ACL deficiency in the study knee.
- Patient has hip arthritis and/or replacement.
- Patient has lateral compartment disease.
- Patient is pregnant or plans to become pregnant during the course of the study.
- Patient is on workman's compensation.
- Patient has a known sensitivity to materials in the device.
Trial locations and contacts
1 site in 1 country.
United States1 site
Anderson Orthopaedic Research Institute
Alexandria, Virginia, 22307
About this study
Official title: A Prospective, Single-Center, Randomized Study Comparing the Functional Performance of the Journey Deuce Bicompartmental With the Genesis II Total Knee System
The objectives of this study are to assess the safety and effectiveness of the Journey Deuce Bicompartmental Knee System at 4-6 weeks, 4 months, 1 year, and 2 years when compared to total knee replacement using the Genesis II Total Knee System. The hypothesis is that the Journey Deuce Bicompartmental Knee System is as safe and effective as the Genesis II Total Knee System at the 2-year. The null hypothesis is that there is no difference between the groups.
- Conditions
- Knee Arthroplasty
- Being tested
- Total Knee Replacement, Deuce
- Keywords
- Total Knee Arthroplasty, Bicompartmental Knee Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee ReplacementDevice
Smith and Nephew Total Knee Replacement
DeuceDevice
Smith and Nephew Bicompartmental Knee Replacement
| Study group | Role | What they receive |
|---|---|---|
| Total | Active comparator | The Smith and Nephew Total Knee System Receives: Device: Total Knee Replacement |
| Deuce | Experimental | The Journey Deuce Bicompartmental Knee System Receives: Device: Deuce |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-Year Knee Society Score
Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.
Measured: 2 years
6-Week Knee Society Score
Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.
Measured: 6 weeks
4-Month Knee Society Score
Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.
Measured: 4 months
1-year Knee Society Score
Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.
Measured: 1 year
Secondary outcomes (9)
6-Week X-rays
Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 6 weeks are reported.
Measured: 6 weeks
4-month X-rays
Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 4 months are reported.
Measured: 4 months
1-year X-rays
Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 1 year are reported.
Measured: 1 year
2-year X-rays
Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 2 years are reported.
Measured: 2 years
2-year Patient Surveys
Serial patient evaluation of function will be assessed using the Oxford Knee Outcome Questionnaire. The Oxford Questionnaire consists of 12 questions, each with a value of 0 (bad) to 4(good). The results are summed for a total score of 0(bad) to 48(good).
Measured: 2 years
6-week Functional Testing
A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.
Measured: 6 weeks
4-month Functional Testing
A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.
Measured: 4 months
1-year Functional Testing
A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.
Measured: 1 year
2-year Functional Testing
A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startSep 2007
- Primary completionMay 2013
- Study completionMay 2013
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 ArthroplastyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anderson Orthopaedic Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Responsible party
- Principal investigator, Nancy Parks, Anderson Orthopaedic Research Institute
- Investigators
- Gerard A. Engh, MD, Principal investigator, AORI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140815
- Sponsor's protocol ID
- AORI2010-0103
- Acronym
- Deuce
- Status last verified
- Jul 2014
- First submitted
- 28 May 2010
- Last updated
- 4 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center, Randomized Study Comparing the Functional Performance of the Journey Deuce Bicompartmental With the Genesis II Total Knee System
- ClinicalTrials.gov ID
- NCT01140815
- Acronym / sponsor ID
- Deuce / AORI2010-0103
- Conditions
- Knee Arthroplasty
- Keywords
- Total Knee Arthroplasty, Bicompartmental Knee Arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Anderson Orthopaedic Research InstituteUniversity, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Study start
- Sep 2007
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 10 Jun 2010 (estimated)
- Results
- Posted 4 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to assess the safety and effectiveness of the Journey Deuce Bicompartmental Knee System at 4-6 weeks, 4 months, 1 year, and 2 years when compared to total knee replacement using the Genesis II Total Knee System. The hypothesis is that the Journey Deuce Bicompartmental Knee System is as safe and effective as the Genesis II Total Knee System at the 2-year. The null hypothesis is that there is no difference between the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total | Active comparator | Device: Total Knee ReplacementThe Smith and Nephew Total Knee System |
| Deuce | Experimental | Device: DeuceThe Journey Deuce Bicompartmental Knee System |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient presents with non-inflammatory degenerative joint disease of the medial and patellofemoral compartments requiring a unilateral knee replacement.
- Patient is 30 to 65 years of age, inclusive.
- Patient is willing to consent to participate in the study by signing and dating an IRB-approved consent form.
- Patient plans to be available for follow-up through 2 years postoperative.
Key exclusion criteria (13 listed)
- Patient is known to have insufficient femoral or tibial bone stock resulting from conditions such as cancer, distal femoral/proximal tibial osteotomy, significant osteoporosis or metabolic bone disorders.
- Patient is immunosuppressed, has an autoimmune disorder, or an immunosuppressive disorder (i.e. chronic condition characterized by markedly inhibited ability to respond to antigenic stimuli.) Examples of such conditions include patients who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses) or patients with acquired immunodeficiency syndrome (AIDS).
- Patient has inflammatory arthritis (e.g. rheumatoid arthritis)
- Patient has BMI > 35.
- Patient has had major knee surgery in the past i.e. HTO, unicondylar knee replacement, failed fracture fixation.
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 |
|---|---|---|
| Total Knee ReplacementSmith and Nephew Total Knee Replacement | Device | Total |
| DeuceSmith and Nephew Bicompartmental Knee Replacement | Device | Deuce |
Primary outcome
2-Year Knee Society Score
Time frame: 2 years
Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.
6-Week Knee Society Score
Time frame: 6 weeks
Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.
4-Month Knee Society Score
Time frame: 4 months
Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.
1-year Knee Society Score
Time frame: 1 year
Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.
9 secondary outcomes
6-Week X-rays
Time frame: 6 weeks
4-month X-rays
Time frame: 4 months
1-year X-rays
Time frame: 1 year
2-year X-rays
Time frame: 2 years
2-year Patient Surveys
Time frame: 2 years
6-week Functional Testing
Time frame: 6 weeks
4-month Functional Testing
Time frame: 4 months
1-year Functional Testing
Time frame: 1 year
2-year Functional Testing
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2014.
- 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.
Gerard A. Engh, MD principal investigator
AORI
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 Total Knee Replacement and Deuce in people with Knee Arthroplasty, run by Anderson Orthopaedic Research Institute 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 4 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 4 Aug 2014. 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 4 Aug 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?
2-Year Knee Society Score (time frame: 2 years). 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?
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 4 Aug 2014; AzTrials last refreshed its copy on 7 Nov 2026.