Study of Silicone-Associated Connective Tissue Diseases

Completed

Conditions studied: Autoimmune Diseases, Connective Tissue Diseases, Scleroderma, Circumscribed, Scleroderma, Systemic

In brief

This study will examine the possible relationship between silicone implants or injections and the connective tissue diseases scleroderma and myositis. It will explore whether certain factors in the blood or the immune system or other factors are involved in the development of these diseases following silicone implantation or injection. Men and women 18 years of age and older who meet the following criteria may be eligible for this study: Group 1-Patients who have had silicone implants or injections and who later developed scleroderma or myositis Group 2-Patients with scleroderma or myositis who have not had silicone implants or injections Group 3-Healthy volunteers who have had silicone implants or injections and did not develop symptoms or other medical features of connective tissue disorders. Participants will have a thorough history and physical examination, blood and urine tests, chest X-ray and lung function tests. In addition, patients will complete a questionnaire about their procedure (including information such as the types of implanted devices and injections, reason for the procedure, post-operative complications, other illnesses or medical conditions present before and after the procedure, etc.).

Key facts

Study ID
NCT00001330
Run by
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
People needed
60
Starts
1992-11-01
Expected to finish
2000-10-01
Last updated by the study team
2008-03-04

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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