Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Link America, Inc.
The specific objectives are to show that the safety data of the S.T.A.R. ankle arthroplasty is similar for treatment of single ankle disease (as defined in the pivotal study) and bilateral ankle disease. The bilateral disease may be identified at the time of enrollment or may have progressed after enrollment and treatment of the first ankle in the pivotal study.
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Moderate or severe pain, loss of mobility and function of the ankle
Primary arthrosis, post traumatic arthrosis or rheumatoid arthrosis
At least six months of conservative treatment for severe ankle conditions
Bilateral ankle disease that have not been enrolled in the pivotal study or single ankle disease and enrolled in the pivotal study but have subsequently developed ankle disease in the contralateral ankle and require surgical intervention
Willing and able to give informed consent
You may not be if
Patients who have not reached skeletal maturity
Active or prior deep infection in the ankle joint or adjacent bones
Prior arthrodesis at the involved site
History of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol
Obesity (weight greater than 250 lbs)
History of current or prior drug abuse or alcoholism
Any physical condition precluding major surgery
Prior surgery and/or injury that has adversely affected the ankle bone stock
Severe osteoporotic or osteopenic condition or other conditions that may lead to inadequate implant fixation in the bone
