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Outcome Study of Total Knee Arthroplasty in Asian Patients (DRAGON)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT00733694
First received: August 11, 2008
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Knee Osteoarthritis
 Device: LCS® Complete™ Mobile Bearing Knee Systems
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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'

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Include Knee Society Score, Radiological Analysis and SF 36 Score [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 592
Study Start Date: April 2000
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733694

Locations
China
Department of Orthopaedic Surgery University of Hong Kong
Hong Kong, China
Sponsors and Collaborators
DePuy International
Investigators
Principal Investigator: Peter Chiu, FRCS Department of Orthopaedic Surgery University of Hong Kong, China
  More Information

No publications provided

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00733694     History of Changes
Other Study ID Numbers: CT 99/33
Study First Received: August 11, 2008
Last Updated: February 12, 2013
Health Authority: Hong Kong: Ethics Committee
Singapore: Domain Specific Review Boards
Japan: Institutional Review Board
Thailand: Ethical Committee

Keywords provided by DePuy International:
Arthroplasty, Replacement, Knee,LCS

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013