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
SexALL
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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…