Clinical trial NCT00586781: Study of the Scandinavian Total Ankle Replacement (STAR) for the Treatment of Bilateral Degenerative Ankle Disease
Official title: Investigational Device Exemption for the Scandinavian Total Ankle Replacement (STAR) - Bilateral Arm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Post-Traumatic Arthritis
Rheumatoid Arthritis
Keywords: ankle replacement
end-stage arthritis of the ankle
degenerative ankle disease
Lead sponsor: Link America, Inc.
Sponsor class: INDUSTRY
First posted: 2008-01-04
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety of the S.T.A.R. device for patients with bilateral disease.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Insufficient ligament support

Primary outcomes:
measure: Safety endpoints to be measured are: • Device failure or device removal/revision • Radiographically confirmed loosening and migration • Complications
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Dallas
country: United States
facility: Orthopedic Associates of Dallas
state: Texas
Study officials:
affiliation: Roger A Mann, Inc
name: Roger A Mann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Foot and Ankle
name: Michael J Coughlin, MD
role: PRINCIPAL_INVESTIGATOR
References: