OsteoarthritisNCT00487565
Clinical Investigation of the LCS® Complete Posterior Stabilized Mobile-bearing Total Knee System
A study testing Total knee arthroplasty in people with Osteoarthritis and Rheumatoid Arthritis, run by DePuy Orthopaedics at 3 sites in United States.
Trial summary
Prospective, multi-center clinical study to evaluate the clinical outcomes of the posterior stabilized design of the LCS® Complete Mobile-bearing Total Knee System Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis
- What is being tested?
- Total knee arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2006to Feb 2011
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- M/F
- 18-80
- Diagnosis of osteoarthritis, rheumatoid , post-traumatic, inflammatory, juvenile arthritis.
- Skeletally mature, sufficient bone stock to seat and support prosthesis
- Willing/able return for follow-up.
- Subject is willing and able to provide informed patient consent for participation in the study
Who cannot join
- History of recent/active joint sepsis, charcot neuropathy, psycho-social disorders, prior knee arthroplasty on affected site, metabolic disorders of calcified tissue
- Communicable diseases that may limit follow-up
- Medical-legal or workers compensation claims.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Colorado Joint Replacement
Denver, Colorado, 80210
Joint Reconstruction Center
Pittsburgh, Pennsylvania, 15260
Jordan-Young Institute
Virginia Beach, Virginia, 23462
About this study
Official title: LCS® PS: A Prospective, Multi-center Clinical Investigation of the LCS® Complete Posterior Stabilized Mobile-bearing Total Knee System
Prospective, multi-center clinical study to evaluate the clinical outcomes of the posterior stabilized design of the LCS® Complete Mobile-bearing Total Knee System
Read the detailed description
Prospective, multi-center study to evaluate the clinical outcome of posterior stabilized design of LCS® Complete Mobile-Bearing Total Knee System. No comparison group. 12 month enrollment, 12 month post-operative evaluation. Follow-up intervals: Pre-op, 3 month, 6 month, and 12 month.
- Being tested
- Total knee arthroplasty
- Keywords
- Total knee replacement, Total knee arthroplasty, Osteoarthritis, Rheumatoid or other inflammatory arthritis, Post-traumatic or juvenile arthritis
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyDevice
Also called LCS® Complete Posterior Stabilized Mobile-bearing Knee
Total knee arthroplasty using a posterior stabilized implant
| Study group | Role | What they receive |
|---|---|---|
| LCS Complete Posterior Stabilized knee implant | Other | Total knee arthroplasty with a posterior stabilized implant Receives: Device: Total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Active Flexion
Active flexion is measured by how much a patient can bend their knee on their own, without assistance.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2007 (estimated)
- Study startSep 2006
- Primary completionFeb 2011
- Study completionFeb 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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tammy O'Dell, EMT, CCRA, CCRC, Study director, DePuy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487565
- Sponsor's protocol ID
- 06005
- Other IDs
- LCS:PS
- Status last verified
- Aug 2013
- First submitted
- 14 Jun 2007
- Last updated
- 14 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LCS® PS: A Prospective, Multi-center Clinical Investigation of the LCS® Complete Posterior Stabilized Mobile-bearing Total Knee System
- ClinicalTrials.gov ID
- NCT00487565
- Acronym / sponsor ID
- 06005
- Keywords
- Total knee replacement, Total knee arthroplasty, Osteoarthritis, Rheumatoid or other inflammatory arthritis, Post-traumatic or juvenile arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 18 Jun 2007 (estimated)
- Results
- Posted 23 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multi-center clinical study to evaluate the clinical outcomes of the posterior stabilized design of the LCS® Complete Mobile-bearing Total Knee System
Detailed description
Prospective, multi-center study to evaluate the clinical outcome of posterior stabilized design of LCS® Complete Mobile-Bearing Total Knee System. No comparison group. 12 month enrollment, 12 month post-operative evaluation. Follow-up intervals: Pre-op, 3 month, 6 month, and 12 month.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LCS Complete Posterior Stabilized knee implant | Other | Device: Total knee arthroplastyTotal knee arthroplasty with a posterior stabilized implant |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- M/F
- 18-80
- Diagnosis of osteoarthritis, rheumatoid , post-traumatic, inflammatory, juvenile arthritis.
- Skeletally mature, sufficient bone stock to seat and support prosthesis
- Willing/able return for follow-up.
Key exclusion criteria (3 listed)
- History of recent/active joint sepsis, charcot neuropathy, psycho-social disorders, prior knee arthroplasty on affected site, metabolic disorders of calcified tissue
- Communicable diseases that may limit follow-up
- Medical-legal or workers compensation claims.
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 arthroplastyAlso: LCS® Complete Posterior Stabilized Mobile-bearing KneeTotal knee arthroplasty using a posterior stabilized implant | Device | LCS Complete Posterior Stabilized knee implant |
Primary outcome
Knee Active Flexion
Time frame: 12 month
Active flexion is measured by how much a patient can bend their knee on their own, without assistance.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink 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.
Tammy O'Dell, EMT, CCRA, CCRC study director
DePuy
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee arthroplasty in people with Osteoarthritis and Rheumatoid Arthritis, run by DePuy Orthopaedics at 3 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 3 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 14 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 23 Mar 2012). 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 Active Flexion (time frame: 12 month). 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 14 Aug 2013.