Status:
COMPLETED
Outcome Study of Total Knee Arthroplasty in Asian Patients
Lead Sponsor:
DePuy International
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE4
Brief Summary
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 wi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
607 Patients enrolled
Trial Details
Trial ID
NCT00733694
Start Date
April 1 2000
End Date
April 1 2008
Last Update
February 28 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Orthopaedic Surgery University of Hong Kong
Hong Kong, China