Back to resultsStudy of the Scandinavian Total Ankle Replacement (STAR) for the Treatment of Bilateral Degenerative Ankle Disease
Primary Purpose
Osteoarthritis, Post-Traumatic Arthritis, Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Scandinavian Total Ankle Replacement (STAR)
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring ankle replacement, end-stage arthritis of the ankle, degenerative ankle disease
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
Sites / Locations
- Mayo Clinic
- University of Iowa
- Kansas University Medical Center
- Duke University Medical Center
- Orthopedic Associates of Dallas
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
3
Arm Description
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.
Outcomes
Primary Outcome Measures
Safety endpoints to be measured are: • Device failure or device removal/revision • Radiographically confirmed loosening and migration • Complications
Secondary Outcome Measures
Full Information
NCT ID
NCT00586781
First Posted
December 21, 2007
Last Updated
December 21, 2007
Sponsor
Link America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00586781
Brief Title
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
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Link America, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Post-Traumatic Arthritis, Rheumatoid Arthritis
Keywords
ankle replacement, end-stage arthritis of the ankle, degenerative ankle disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Scandinavian Total Ankle Replacement (STAR)
Intervention Description
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 Measure Information:
Title
Safety endpoints to be measured are: • Device failure or device removal/revision • Radiographically confirmed loosening and migration • Complications
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger A Mann, MD
Organizational Affiliation
Roger A Mann, Inc
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael J Coughlin, MD
Organizational Affiliation
Foot and Ankle
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Orthopedic Associates of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of the Scandinavian Total Ankle Replacement (STAR) for the Treatment of Bilateral Degenerative Ankle Disease
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