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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
LCS® Complete™ Mobile Bearing Knee Systems
Sponsored by
DePuy International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Arthroplasty, Replacement, Knee,LCS

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Orthopaedic Surgery University of Hong Kong

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

LCS® Complete™ Mobile Bearing Knee Systems

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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

Full Information

First Posted
August 11, 2008
Last Updated
December 17, 2015
Sponsor
DePuy International
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1. Study Identification

Unique Protocol Identification Number
NCT00733694
Brief Title
Outcome Study of Total Knee Arthroplasty in Asian Patients
Acronym
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'
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy International

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Arthroplasty, Replacement, Knee,LCS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
607 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LCS® Complete™ Mobile Bearing Knee Systems
Arm Type
Other
Arm Description
An orthopaedic implant for primary total knee replacement with a mobile bearing knee
Intervention Type
Device
Intervention Name(s)
LCS® Complete™ Mobile Bearing Knee Systems
Intervention Description
An orthopaedic implant for primary total knee replacement with a mobile bearing knee
Primary Outcome Measure Information:
Title
Change in Oxford Knee Score
Description
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.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
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
Title
Adverse Events
Description
All intraoperative and postoperative adverse incidences/complications and their relationship to the knee will be collected
Time Frame
5 years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Department of Orthopaedic Surgery University of Hong Kong
City
Hong Kong
Country
China

12. IPD Sharing Statement

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Outcome Study of Total Knee Arthroplasty in Asian Patients

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