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Completed

NCT Number: NCT00733694

Outcome Study of Total Knee Arthroplasty in Asian Patients

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

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Key information

Age range

Up to 75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Orthopaedic Surgery University of Hong Kong

Hong Kong, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LCS® Complete™ Mobile Bearing Knee Systems

Device

An orthopaedic implant for primary total knee replacement with a mobile bearing knee

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Adverse Events

    Time frame: 5 years

    All intraoperative and postoperative adverse incidences/complications and their relationship to the knee will be collected

Sponsors and collaborators

Lead sponsor

DePuy International

Industry

Registry information

Official study 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'

Acronym: DRAGON

Important dates

Study start
2000
Primary completion
2008
Study completion
2008
First posted
Aug 13, 2008
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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