Knee OsteoarthritisPhase 4DRAGONNCT00733694
Outcome Study of Total Knee Arthroplasty in Asian Patients
A Phase 4 study testing LCS® Complete™ Mobile Bearing Knee Systems in people with Knee Osteoarthritis, run by DePuy International at 1 site in China.
Trial summary
To determine how the LCS mobile bearing knee system works within the Asian Population. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- LCS® Complete™ Mobile Bearing Knee Systems
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 607 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2000to 1 Apr 2008
- 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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Administrative - the patient is able to understand the evaluation, is able to give consent and will comply with the postoperative follow up regime.
- Diagnosis - 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.
- Implant suitability - patients who in the opinion of the Clinical Investigator are considered suitable for treatment with a mobile bearing knee system (the LCS Classic or Universal).
- Bilateral patients - simultaneous bilateral patients are included. Staged bilateral patients are included if the second procedure is performed within the one-year recruitment period. Staged bilateral patients where the second procedure is performed outside of the one-year recruitment period will only be included if the second procedure is performed within 6 months of the end of the one-year recruitment period.
- Age - the upper age limit is set at 75 years and expected to live through the 5 years study period.vi. Ethnic Origin - patients must be Asian in ethnic origin
- Unicondylar / High Tibial Osteotomy (HTO) conversion - patients that are being converted from a unicondylar / HTO procedure are included providing the reason for conversion is due to progression of the disease process affecting the other condyle. Patients that are converted and have evidence of infection / aseptic loosening / loss of bone stock are excluded.
Who cannot join
- Patients with a known history of poor compliance to medical treatment.
- Patients that require revision surgery
- Patients with gross ligamentous insufficiency.
- Patients with a severe valgus deformity (15 degrees or greater)
- Patients with a severe varus deformity (20 degrees or greater)
- Patients with a fixed flexion contracture (30 degrees or greater)
- Patients over the age of 75 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Low Contact Stress (LCS) Classic and Universal Mobile-bearing Total Knee System. The Asian LCS User Group - 'The Dragon Knee Study'
To determine how the LCS mobile bearing knee system works within the Asian Population.
Read the detailed description
The objective of this clinical evaluation is to compile a profile of the performance of the LCS Mobile bearing total knee system in normal clinical practice within the Asian Population. Performance will be assessed using specific surgeon and patient based outcome scores.
Total subject enrolled 505; 6 subjects did not receive device. Total subjects received device 499.
Among those who received devices, 391 subjects unilateral and 108 bilateral, therefore, total 607 knees in the study
- Conditions
- Knee Osteoarthritis
- Being tested
- LCS® Complete™ Mobile Bearing Knee Systems
- Keywords
- Arthroplasty, Replacement, Knee,LCS
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCS® Complete™ Mobile Bearing Knee SystemsDevice
An orthopaedic implant for primary total knee replacement with a mobile bearing knee
| Study group | Role | What they receive |
|---|---|---|
| LCS® Complete™ Mobile Bearing Knee Systems | Other | An orthopaedic implant for primary total knee replacement with a mobile bearing knee Receives: Device: LCS® Complete™ Mobile Bearing Knee Systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oxford Knee Score
Oxford Knee Score will be summarized pre-operatively and at each subsequent post-operative follow-up. The change from pre-op to final post-operative assessment at 5 years will be derived and used as the analysis variable.
Measured: 5 years
Secondary outcomes (2)
Change in Quality of Life Score (SF-36), Knee Society Score, Anterior Pain and radiographic/radiolucent details from pre-op to 5 year post-op follow up.
Measured: 5 years
Adverse Events
All intraoperative and postoperative adverse incidences/complications and their relationship to the knee will be collected
Measured: 5 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 Apr 2000
- Primary completion1 Apr 2008
- Study completion1 Apr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 607 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
- NCT00733694
- Sponsor's protocol ID
- CT 99/33
- Acronym
- DRAGON
- Status last verified
- Feb 2025
- First submitted
- 11 Aug 2008
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Low Contact Stress (LCS) Classic and Universal Mobile-bearing Total Knee System. The Asian LCS User Group - 'The Dragon Knee Study'
- ClinicalTrials.gov ID
- NCT00733694
- Acronym / sponsor ID
- DRAGON / CT 99/33
- Conditions
- Knee Osteoarthritis
- Keywords
- Arthroplasty, Replacement, Knee,LCS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 607 participants (actual)
- Lead sponsor
- DePuy InternationalIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2000 (actual)
- Primary completion
- 1 Apr 2008 (actual)
- Study completion
- 1 Apr 2008 (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.
To determine how the LCS mobile bearing knee system works within the Asian Population.
Detailed description
The objective of this clinical evaluation is to compile a profile of the performance of the LCS Mobile bearing total knee system in normal clinical practice within the Asian Population. Performance will be assessed using specific surgeon and patient based outcome scores.
Total subject enrolled 505; 6 subjects did not receive device. Total subjects received device 499.
Among those who received devices, 391 subjects unilateral and 108 bilateral, therefore, total 607 knees in the study
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LCS® Complete™ Mobile Bearing Knee Systems | Other | Device: LCS® Complete™ Mobile Bearing Knee SystemsAn orthopaedic implant for primary total knee replacement with a mobile bearing knee |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Administrative - the patient is able to understand the evaluation, is able to give consent and will comply with the postoperative follow up regime.
- Diagnosis - 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.
- Implant suitability - patients who in the opinion of the Clinical Investigator are considered suitable for treatment with a mobile bearing knee system (the LCS Classic or Universal).
- Bilateral patients - simultaneous bilateral patients are included. Staged bilateral patients are included if the second procedure is performed within the one-year recruitment period. Staged bilateral patients where the second procedure is performed outside of the one-year recruitment period will only be included if the second procedure is performed within 6 months of the end of the one-year recruitment period.
- Age - the upper age limit is set at 75 years and expected to live through the 5 years study period.vi. Ethnic Origin - patients must be Asian in ethnic origin
Key exclusion criteria (7 listed)
- Patients with a known history of poor compliance to medical treatment.
- Patients that require revision surgery
- Patients with gross ligamentous insufficiency.
- Patients with a severe valgus deformity (15 degrees or greater)
- Patients with a severe varus deformity (20 degrees or greater)
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 |
|---|---|---|
| LCS® Complete™ Mobile Bearing Knee SystemsAn orthopaedic implant for primary total knee replacement with a mobile bearing knee | Device | LCS® Complete™ Mobile Bearing Knee Systems |
Primary outcome
Change in Oxford Knee Score
Time frame: 5 years
Oxford Knee Score will be summarized pre-operatively and at each subsequent post-operative follow-up. The change from pre-op to final post-operative assessment at 5 years will be derived and used as the analysis variable.
2 secondary outcomes
Change in Quality of Life Score (SF-36), Knee Society Score, Anterior Pain and radiographic/radiolucent details from pre-op to 5 year post-op follow up.
Time frame: 5 years
Adverse Events
Time frame: 5 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 28 Feb 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 LCS® Complete™ Mobile Bearing Knee Systems in people with Knee Osteoarthritis, run by DePuy International at 1 site in China.
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 7 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 28 Feb 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 China. 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?
Change in Oxford Knee Score (time frame: 5 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 28 Feb 2025.