2-Year Post-Approval Study to Investigate the Scandinavian Total Ankle Replacement System (STAR) … (NCT01284283) | Clinical Trial Compass
CompletedNot Applicable
2-Year Post-Approval Study to Investigate the Scandinavian Total Ankle Replacement System (STAR) Ankle Under Actual Conditions of Use
United States102 participantsStarted 2009-11
Plain-language summary
This post-approval study is being conducted to examine the performance of the STAR Ankle under actual conditions of use.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Moderate or severe pain, loss of mobility and function of the ankle (Buechel-Pappas Scale)
* Primary arthrosis, post traumatic arthrosis or rheumatoid arthrosis
* At least six months of conservative treatment for severe ankle conditions, confirmed by the patient medical history, radiograph studies and medication record
* Willing and able to give informed consent
Exclusion Criteria:
* Patients who have not reached skeletal maturity
* Active or prior deep infection inthe 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 prior drug abuse or alcoholism
* Any physical condition precluding major surgery
* Hindfoot malpositioned by more than 35 degrees or forefoot malalignment which would preclude a plantigrade foot
* Lower extremity vascular insufficiency demonstrated by Doppler arterial pressure
* Avascular necrosis of the talus
* Inadequate skin coverage above the ankle joint
* Patients under the age of 35 who are unwilling or unable to accept the physical limitations imposed by ankle arthroplasty, including limitations on certain vigorous physical activities (e.g. basketball, football) and on manual labor
* Juvenile onset Type I diabetes
* Adult onset Type II diabetes when accompanied by neuropathic changes or a history of foot i…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.