Outcome Study of Total Knee Arthroplasty in Asian Patients

Knee Osteoarthritis Clinical Trial

— DRAGON  

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'

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00733694
• Other study ID #: CT 99/33
• Status: Completed
• Phase: Phase 4
• First received: August 11, 2008
• Last updated: December 17, 2015
• Start date: April 2000
• Est. completion date: April 2008

Study information

• Verified date: December 2015
• Source: DePuy International
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics CommitteeSingapore: Domain Specific Review BoardsJapan: Institutional Review BoardThailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

To determine how the LCS mobile bearing knee system works within the Asian Population.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 607
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 75 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• LCS® Complete™ Mobile Bearing Knee Systems
An orthopaedic implant for primary total knee replacement with a mobile bearing knee

Locations

Country	Name	City	State
China	Department of Orthopaedic Surgery University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
DePuy International

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Adverse Events	All intraoperative and postoperative adverse incidences/complications and their relationship to the knee will be collected	5 years	Yes