Clinical trial NCT02124031: Mexican Initiative of Patients With Osteoarthritis and Rheumatoid Arthritis (IMPACTAR)
Official title: Mexican Initiative of Patients With Osteoarthritis and Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Disability
Joint Function Disorder
Axis IV Problems Economic
Compliance Behavior
Complications; Arthroplasty
Keywords: Osteoarthritis
Rheumatoid Arthritis
Disability
Joint function
Lead sponsor: Iniciativa Mexicana de Pacientes con Osteoartritis y Artritis Reumatoide
Sponsor class: OTHER
Collaborators: name: Sanofi
name: Webmedica
First posted: 2014-04-28
Enrollment: 10241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The Registry will include male and female patients older than 18 years with knee and/or hand OA and/or RA diagnosis according with the American College of Rheumatology criteria. It will include consecutive outpatients that are treated in any of the participant specialties of the study (orthopedics, rheumatology, internal medicine, rehabilitation medicine).

Brief summary: The purpose of this study is to evaluate quality of life, degree of disability, treatment patterns and economic impact of hand and knee Osteoarthritis and Rheumatoid Arthritis in Mexico.

Detailed description: The osteoarthritis (OA) is a chronic and degenerative disease of multifactorial etiology, characterized by the gradual loss of articular cartilage. It is a question of one of the most common rheumatic disorders in the population, is the most habitual reason of pain and disability in the major adults and the first reason of surgeries of articular replacement. In Mexico, in a study of national area, the prevalence of locomotives manifestations was 26 %, with predominance in the women. Nowadays criteria exist for the classification of the OA, based on epidemiological studies, for the knee, the hip and the hand. Basically they have been established to homogenize studies of clinical epidemiological type. In other hand, the Rheumatoid Arthritis (RA) is an inflammatory, chronic, systemic disease that has more prominent manifestations in the diarthrodial joints. The disease have a wide range of characteristics, from the progressively chronic disease with variable degrees of destruction to articulate up to the extra-articular manifestations clinically evident. Demographically, the RA is the most common form of inflammatory arthritis and affects approximately 0.5 to 1 % of the world population, with an economic impact comparable with arterial coronary disease. The National Institute of Geographical Statistics (INEGI) thinks that in Mexico the population of major adults will double in the next decades, for what the impact of these rheumatic disorders will be serious and will turn into a problem of public health.

Based in the previous information, the Mexican Initiative of Patients with OA and RA (IMPACTAR), will on patient interview to increase the knowledge regarding the number of affected adults and the current treatment strategies.

This will be the first Mexican Registry related with Osteoarticular diseases.

Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years with diagnosis of OA or RA according to the criteria of the American College of Rheumatology (ACR).

Exclusion Criteria:

* Patients with precedents of fractures; carrying patients of chronic diseases who limit them in the functional capacity.

Primary outcomes:
measure: Quality of life
timeFrame: Previous six months
Secondary outcomes:
measure: Articular function
timeFrame: Previous six months
Other outcomes:
Locations:
Study officials:
affiliation: National Institute of Rehabilitation
name: Rolando Espinosa, M. D.
role: PRINCIPAL_INVESTIGATOR
References: