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Study of the Scandinavian Total Ankle Replacement (STAR) for the Treatment of Bilateral Degenerative Ankle Disease

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ClinicalTrials.gov Identifier: NCT00586781
Recruitment Status : Completed
First Posted : January 4, 2008
Last Update Posted : January 4, 2008
Sponsor:
Information provided by:
Link America, Inc.

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

Condition or disease Intervention/treatment Phase
Osteoarthritis Post-Traumatic Arthritis Rheumatoid Arthritis Device: Scandinavian Total Ankle Replacement (STAR) Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigational Device Exemption for the Scandinavian Total Ankle Replacement (STAR) - Bilateral Arm
Study Start Date : September 2001
Primary Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 3
The S.T.A.R. ankle system is the study device. The device has three parts: two metal bearing surfaces (cobalt-chromium alloy) plates with bars that fit into the bone and one plastic (polyethylene) spacer that moves between the metal plates like a ball bearing. The materials in the S.T.A.R. device are the same materials used in total hip and knee implants. Both ankles of every subject will be treated with the STAR ankle.
Device: Scandinavian Total Ankle Replacement (STAR)
The device has three parts: two metal bearing surfaces (cobalt-chromium alloy) plates with bars that fit into the bone and one plastic (polyethylene) spacer that moves between the metal plates like a ball bearing. The materials in the S.T.A.R. device are the same materials used in total hip and knee implants.



Primary Outcome Measures :
  1. Safety endpoints to be measured are: • Device failure or device removal/revision • Radiographically confirmed loosening and migration • Complications [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00586781


Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Texas
Orthopedic Associates of Dallas
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Link America, Inc.
Investigators
Principal Investigator: Roger A Mann, MD Roger A Mann, Inc
Principal Investigator: Michael J Coughlin, MD Foot and Ankle

Responsible Party: Andrew Greenberg, President, Link America, Inc
ClinicalTrials.gov Identifier: NCT00586781     History of Changes
Other Study ID Numbers: Link-3
First Posted: January 4, 2008    Key Record Dates
Last Update Posted: January 4, 2008
Last Verified: December 2007

Keywords provided by Link America, Inc.:
ankle replacement
end-stage arthritis of the ankle
degenerative ankle disease

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases