Study of the Scandinavian Total Ankle Replacement (STAR) for the Treatment of Bilateral Degenerative Ankle Disease - Full Text View

Sponsored by:	Link America, Inc.
Information provided by:	Link America, Inc.
ClinicalTrials.gov Identifier:	NCT00586781

Purpose

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

Condition	Intervention	Phase
Osteoarthritis Post-Traumatic Arthritis Rheumatoid Arthritis	Device: Scandinavian Total Ankle Replacement (STAR)	Phase III

MedlinePlus related topics: Osteoarthritis Rheumatoid Arthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	Investigational Device Exemption for the Scandinavian Total Ankle Replacement (STAR) - Bilateral Arm

Further study details as provided by Link America, Inc.:

Primary Outcome Measures:

Safety endpoints to be measured are: • Device failure or device removal/revision • Radiographically confirmed loosening and migration • Complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment:	21
Study Start Date:	September 2001
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
3: Experimental 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.

Arms

Assigned Interventions

3: Experimental

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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

No publications provided

Responsible Party:	Link America, Inc ( Andrew Greenberg, President )
Study ID Numbers:	Link-3
Study First Received:	December 21, 2007
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00586781 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Link America, Inc.:

ankle replacement
end-stage arthritis of the ankle
degenerative ankle disease

Study placed in the following topic categories:

Autoimmune Diseases
Chromium
Musculoskeletal Diseases
Osteoarthritis
Cobalt

Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 07, 2009