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'

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

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: LCS® Complete™ Mobile Bearing Knee Systems

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 Type: Interventional
• Enrollment (Actual): 607
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Department of Orthopaedic Surgery University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: LCS® Complete™ Mobile Bearing Knee Systems; An orthopaedic implant for primary total knee replacement with a mobile bearing knee	Device: LCS® Complete™ Mobile Bearing Knee Systems; An orthopaedic implant for primary total knee replacement with a mobile bearing knee

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	All intraoperative and postoperative adverse incidences/complications and their relationship to the knee will be collected	5 years

Collaborators and Investigators

• Sponsor: DePuy International

Study record dates

Study Major Dates

• Study Start: April 1, 2000
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: August 11, 2008
• First Submitted That Met QC Criteria: August 12, 2008
• First Posted (Estimate): August 13, 2008

Study Record Updates

• Last Update Posted (Estimate): December 18, 2015
• Last Update Submitted That Met QC Criteria: December 17, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Arthroplasty, Replacement, Knee,LCS
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: CT 99/33