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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00733694
First Posted: August 13, 2008
Last Update Posted: December 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
DePuy International
  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: Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Change in Oxford Knee Score [ Time Frame: 5 years ]
    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.


Secondary Outcome Measures:
  • 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. [ Time Frame: 5 years ]
  • Adverse Events [ Time Frame: 5 years ]
    All intraoperative and postoperative adverse incidences/complications and their relationship to the knee will be collected


Enrollment: 607
Study Start Date: April 2000
Study Completion Date: April 2008
Primary Completion Date: April 2008 (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.

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00733694


Locations
China
Department of Orthopaedic Surgery University of Hong Kong
Hong Kong, China
Sponsors and Collaborators
DePuy International
  More Information

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00733694     History of Changes
Other Study ID Numbers: CT 99/33
First Submitted: August 11, 2008
First Posted: August 13, 2008
Last Update Posted: December 18, 2015
Last Verified: December 2015

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

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