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NCT00462319 Clinical Trial

ARTIST: ARThrose Intervention STandardisée

Knee Osteoarthritis Clinical Trial

— ARTIST  

Official title:
Evaluation of Standardized Management of Knee Arthritis Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00462319
Other study ID # 2004/07
Secondary ID
Status Completed
Phase Phase 4
First received April 18, 2007
Last updated April 18, 2007
Start date May 2005

Study information
Verified date April 2007
Source Almirall, SAS
Contact n/a
Is FDA regulated No
Health authority France: Person Protection Committee CPP
Study type Interventional

Clinical Trial Summary

International recommendations (ACR,EULAR) emphasize physical exercise and weight loss for patients suffering from knee osteoarthritis. Nevertheless, number of patients receiving advices for these 2 points still low. This study evaluates the impact of a standardized medical intervention (patient education, weight reduction and physical exercise) in knee osteoarthritis patients.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 45 Years to 75 Years
Eligibility Inclusion Criteria:

- symptomatic and ambulatory patients

- suffering from knee osteoarthritis (ACR criteria)

- 25<BMI<35

- signed informed consent

Exclusion Criteria:

- need to surgery within 6 next months

- co-morbidity

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

Intervention

Behavioral:
• Education, weight reduction and physical exercise

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Almirall, SAS

Country where clinical trial is conducted

France, 

References & Publications (2)

Messier SP, Gutekunst DJ, Davis C, DeVita P. Weight loss reduces knee-joint loads in overweight and obese older adults with knee osteoarthritis. Arthritis Rheum. 2005 Jul;52(7):2026-32. — View Citation

Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum. 2000 Sep;43(9):1905-15. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Weight
Primary Physical Exercise in Leisure
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