Arthroplasty, Replacement, KneePhase 4NCT00733915
Long-term Study of the DePuy Low Contact Stress (LCS) Complete Total Knee System
A Phase 4 study testing L.C.S. Complete Knee (DePuy Low Contact Stress Complete Knee System) in people with Arthroplasty, Replacement, Knee, run by DePuy International at 1 site in Ireland.
Trial summary
The main objective of this study is to evaluate how the LCS Complete mobile-bearing total knee system and surgical instrumentation performs. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- L.C.S. Complete Knee (DePuy Low Contact Stress Complete Knee System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteIreland
- Study dates
- 1 Mar 2002to 1 Oct 2014
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female subjects.
- Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained
- Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- Subjects who present with idiopathic osteoarthritis, rheumatoid arthritis, post traumatic arthritis or any other pathology that in the opinion of the clinical investigator requires a primary total knee arthroplasty and who are considered suitable for treatment with a mobile bearing knee system (LCS Complete).
- Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with the investigation device, according to the indications specified in the package insert leaflet.
Who cannot join
- Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
- Subjects with a known history of poor compliance to medical treatment.
- Women who are pregnant.
- Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
- Subjects involved in Medical-Legal claims.
- Subjects who have participated in a clinical study with an investigational product in the last month.
- Subjects who are currently involved in any injury litigation claims.
- Revision of an existing knee implant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Non-Comparative Study to Evaluate the Performance of the DePuy Low Contact Stress (LCS) Complete Mobile-bearing Total Knee System.
The main objective of this study is to evaluate how the LCS Complete mobile-bearing total knee system and surgical instrumentation performs.
Read the detailed description
The secondary objective of this investigation is to evaluate the long-term survivorship and performance of the LCS Complete mobile-bearing total knee system and surgical instrumentation using the American Knee Society Score (AKS) the Oxford Knee Score (OKS), SF-12 and survivorship analysis.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- L.C.S. Complete Knee (DePuy Low Contact Stress Complete Knee System)
- Keywords
- Arthroplasty, knee, TKA, TKR, Duofix, Porocoat, LCS
- Medical subject headings
- Aagenaes syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L.C.S. Complete Knee (DePuy Low Contact Stress Complete Knee System)Device
L.C.S. Complete mobile-bearing total knee system
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Cohort of total knee replacements with LCS Complete knee implants Receives: Device: L.C.S. Complete Knee (DePuy Low Contact Stress Complete Knee System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the surgical performance of the LCS Complete mobile-bearing total knee system and instrumentation using radiographic and intra-operative assessment
Measured: 10 years
Secondary outcomes (1)
To demonstrate the survivorship and performance of the LCS Complete mobile-bearing total knee system using the American Knee Society clinical and radiographic assessment, Oxford Knee Score, SF12 and survivorship analysis.
Measured: Pre surgery, surgery, 3 month, 1, 3, 5 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2008 (estimated)
- Study start1 Mar 2002
- Primary completion1 Sep 2007
- Study completion1 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies 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
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00733915
- Sponsor's protocol ID
- CT 01/13
- Status last verified
- Sep 2025
- First submitted
- 11 Aug 2008
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-Comparative Study to Evaluate the Performance of the DePuy Low Contact Stress (LCS) Complete Mobile-bearing Total Knee System.
- ClinicalTrials.gov ID
- NCT00733915
- Acronym / sponsor ID
- CT 01/13
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- Arthroplasty, knee, TKA, TKR, Duofix, Porocoat, LCS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- DePuy InternationalIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2002 (actual)
- Primary completion
- 1 Sep 2007 (actual)
- Study completion
- 1 Oct 2014 (actual)
- First posted
- 13 Aug 2008 (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.
The main objective of this study is to evaluate how the LCS Complete mobile-bearing total knee system and surgical instrumentation performs.
Detailed description
The secondary objective of this investigation is to evaluate the long-term survivorship and performance of the LCS Complete mobile-bearing total knee system and surgical instrumentation using the American Knee Society Score (AKS) the Oxford Knee Score (OKS), SF-12 and survivorship analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Device: L.C.S. Complete Knee (DePuy Low Contact Stress Complete Knee System)Cohort of total knee replacements with LCS Complete knee implants |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects.
- Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained
- Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- Subjects who present with idiopathic osteoarthritis, rheumatoid arthritis, post traumatic arthritis or any other pathology that in the opinion of the clinical investigator requires a primary total knee arthroplasty and who are considered suitable for treatment with a mobile bearing knee system (LCS Complete).
- Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with the investigation device, according to the indications specified in the package insert leaflet.
Key exclusion criteria (8 listed)
- Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
- Subjects with a known history of poor compliance to medical treatment.
- Women who are pregnant.
- Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
- Subjects involved in Medical-Legal 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 |
|---|---|---|
| L.C.S. Complete Knee (DePuy Low Contact Stress Complete Knee System)L.C.S. Complete mobile-bearing total knee system | Device | Single arm |
Primary outcome
To demonstrate the surgical performance of the LCS Complete mobile-bearing total knee system and instrumentation using radiographic and intra-operative assessment
Time frame: 10 years
1 secondary outcome
To demonstrate the survivorship and performance of the LCS Complete mobile-bearing total knee system using the American Knee Society clinical and radiographic assessment, Oxford Knee Score, SF12 and survivorship analysis.
Time frame: Pre surgery, surgery, 3 month, 1, 3, 5 and 10 years
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 12 Sep 2025.
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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.
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 L.C.S. Complete Knee (DePuy Low Contact Stress Complete Knee System) in people with Arthroplasty, Replacement, Knee, run by DePuy International at 1 site in Ireland.
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 5 inclusion and 8 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 12 Sep 2025. 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 Ireland. 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?
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?
To demonstrate the surgical performance of the LCS Complete mobile-bearing total knee system and instrumentation using radiographic and intra-operative assessment (time frame: 10 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 12 Sep 2025.