2-Year Post-Approval Study to Investigate the Scandinavian Total Ankle Replacement System (STAR) Ankle Under Actual Conditions of Use



Status:Active, not recruiting
Conditions:Arthritis, Osteoarthritis (OA), Rheumatoid Arthritis, Orthopedic
Therapuetic Areas:Rheumatology, Orthopedics / Podiatry
Healthy:No
Age Range:Any
Updated:3/21/2019
Start Date:November 2009
End Date:March 2021

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2-Year Post-Approval Study to Investigate the STAR Ankle Under Actual Conditions of Use

This post-approval study is being conducted to examine the performance of the STAR Ankle
under actual conditions of use.

This investigation is a prospective, multi-center, single-arm study. 98 subjects are to be
enrolled in this clinical investigation. Enrolled subjects will be assessed at Pre-Operative,
Operative/Discharge, and at 6 Weeks, 6, 12, and 24 Months after the index procedure. Safety,
efficacy, and effectiveness analyses will be performed for all follow-up points during the
study.

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 infection in either foot

- Pregnancy

- Avascular necrosis of the tibia

- Significant bone tumor of the foot or ankle

- Severe deformity that would not normally be eligible for ankle 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

- Motor dysfunction due to neuromuscular impairment
We found this trial at
9
sites
795 El Camino Real
Palo Alto, California 94301
Principal Investigator: Shannon Rush, DPM
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: David Thordarson, MD
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Dallas, Texas 75231
Principal Investigator: Charles E Cook, MD
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240 East 18th Street
New York, New York 10003
Principal Investigator: Kenneth Mroczek, MD
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Philadelphia, Pennsylvania 19106
Principal Investigator: Keith L Wapner, MD
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Philadelphia, PA
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Phoenix, Arizona 85023
Principal Investigator: Jeffrey McAlister, DPM
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555 North Arlington Avenue
Reno, Nevada 89503
Principal Investigator: Gregg Lundeen, MD
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Reno, NV
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Royal Oak, Michigan 48073
Principal Investigator: Allen Grant, MD
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Royal Oak, MI
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San Francisco, California 94115
Principal Investigator: John M Schuberth, DPM
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San Francisco, CA
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