OsteoarthritisNCT01704326
A Study of Patients Treated With the Journey Deuce Bicompartmental Knee System
An observational study of Osteoarthritis, run by Smith & Nephew, Inc. at 4 sites in United States.
Trial summary
This is a prospective, multicenter, consecutive clinical study of the Journey Deuce Knee System and is intended to evaluate the safety and effectiveness of the new device. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- How many people
- 59 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2006to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients eligible for this study are non-inflammatory degenerative joint disease patients requiring a primary unilateral knee surgery. The affected areas must be limited to the medial and patellofemoral compartments.
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 75 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 five 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 greater than or equal to 40.
- 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.
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- Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and followup (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 has a known sensitivity to materials in the device.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Iowa Orthopaedic Center, PC
Des Moines, Iowa, 50314
Henry County Center for Orthopedic Surgery & Sports Medicine
New Castle, Indiana, 47362
Orthopaedic Surgery Specialists, Ltd.
Park Ridge, Illinois, 60068
Orthopaedic Center of Vero Beach
Vero Beach, Florida, 32860
About this study
Official title: A Prospective, Multicenter Consecutive Series Study of Patients Treated With the Journey Deuce Bicompartmental Knee System
This is a prospective, multicenter, consecutive clinical study of the Journey Deuce Knee System and is intended to evaluate the safety and effectiveness of the new device.
Read the detailed description
The objectives of this study are to assess the safety and effectiveness of the Journey Deuce Bicompartmental Knee System. Patients will be examined clinically at time intervals throughout the study duration. Exams will include completion of clinical assessment, x-rays, and completion of patient questionnaires.
- Conditions
- Osteoarthritis
- Keywords
- Deuce, Journey Deuce, Knee pain, Osteoarthritis, Bicompartmental, Femoral, Medial
- Medical subject headings
- Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee Society Score
Assess knee pain, function and range of motion using the Knee Society Clinical Rating System
Measured: Preoperative-2 years
Secondary outcomes (4)
Oxford Knee Outcome Questionnaire
Patient evaluation of function
Measured: Preoperative, 6 weeks, 3 months, 6 months, 1 year and 2 years
Radiographic Evaluation
X-rays will be assessed for evidence of implant loosening, surface wear, migration or any other clinical or radiographic abnormalities.
Measured: 6 weeks, 1 year and 2 years
Patient Satisfaction
Patient satisfaction questionnaire to be completed at each follow-up visit
Measured: 6 weeks, 3 months, 6 months, 1 year and 2 years
Adverse Events
All intra-operative, discharge, and post-operative surgical/hospitalization or study knee-related adverse events will be captured during the study to assess for safety issues.
Measured: When Necessary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startSep 2006
- Primary completionFeb 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704326
- Sponsor's protocol ID
- DEUK01
- Status last verified
- Oct 2012
- First submitted
- 24 Sep 2012
- Last updated
- 11 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Consecutive Series Study of Patients Treated With the Journey Deuce Bicompartmental Knee System
- ClinicalTrials.gov ID
- NCT01704326
- Acronym / sponsor ID
- DEUK01
- Conditions
- Osteoarthritis
- Keywords
- Deuce, Journey Deuce, Knee pain, Osteoarthritis, Bicompartmental, Femoral, Medial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Feb 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 11 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multicenter, consecutive clinical study of the Journey Deuce Knee System and is intended to evaluate the safety and effectiveness of the new device.
Detailed description
The objectives of this study are to assess the safety and effectiveness of the Journey Deuce Bicompartmental Knee System. Patients will be examined clinically at time intervals throughout the study duration. Exams will include completion of clinical assessment, x-rays, and completion of patient questionnaires.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients eligible for this study are non-inflammatory degenerative joint disease patients requiring a primary unilateral knee surgery. The affected areas must be limited to the medial and patellofemoral compartments.
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 75 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 five years postoperative.
Key exclusion criteria (12 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 greater than or equal to 40.
- 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.
Primary outcome
Change in Knee Society Score
Time frame: Preoperative-2 years
Assess knee pain, function and range of motion using the Knee Society Clinical Rating System
4 secondary outcomes
Oxford Knee Outcome Questionnaire
Time frame: Preoperative, 6 weeks, 3 months, 6 months, 1 year and 2 years
Radiographic Evaluation
Time frame: 6 weeks, 1 year and 2 years
Patient Satisfaction
Time frame: 6 weeks, 3 months, 6 months, 1 year and 2 years
Adverse Events
Time frame: When Necessary
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Osteoarthritis, run by Smith & Nephew, Inc. 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 4 inclusion and 12 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 11 Oct 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Knee Society Score (time frame: Preoperative-2 years). 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 11 Oct 2012.