Outcome Study of Total Knee Arthroplasty in Asian Patients
DRAGON
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'
1 other identifier
interventional
607
1 country
1
Brief Summary
To determine how the LCS mobile bearing knee system works within the Asian Population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 knee-osteoarthritis
Started Apr 2000
Longer than P75 for phase_4 knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 11, 2008
CompletedFirst Posted
Study publicly available on registry
August 13, 2008
CompletedFebruary 28, 2025
February 1, 2025
8 years
August 11, 2008
February 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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.
5 years
Adverse Events
5 years
Study Arms (1)
LCS® Complete™ Mobile Bearing Knee Systems
OTHERAn orthopaedic implant for primary total knee replacement with a mobile bearing knee
Interventions
An orthopaedic implant for primary total knee replacement with a mobile bearing knee
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Orthopaedic Surgery University of Hong Kong
Hong Kong, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2008
First Posted
August 13, 2008
Study Start
April 1, 2000
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
February 28, 2025
Record last verified: 2025-02