- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01284283
2-Year Post-Approval Study to Investigate the Scandinavian Total Ankle Replacement System (STAR) Ankle Under Actual Conditions of Use (STAR 2 PAS)
2-Year Post-Approval Study to Investigate the STAR Ankle Under Actual Conditions of Use
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85023
- The Core Institute
-
-
California
-
Los Angeles, California, United States, 90048
- Cedars Sinai Medical Center
-
Palo Alto, California, United States, 94301
- Palo Alto Medical Research Foundation (Sutter Health)
-
San Francisco, California, United States, 94118
- Kaiser Permanente
-
-
Michigan
-
Royal Oak, Michigan, United States, 48085
- William Beaumont Hospital
-
-
Nevada
-
Reno, Nevada, United States, 89503
- Reno Orthopaedic Center
-
-
New York
-
New York, New York, United States, 10003
- Kenneth Mroczek, MD-NYU
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19106
- University of Pennsylvania Health Systems-PA Foot and Ankle Surgeons
-
-
Texas
-
Dallas, Texas, United States, 75231
- Center for Foot and Ankle Restoration
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Single
Device: Scandinavian Total Ankle Replacement System (STAR Ankle)
|
For total ankle replacement
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Endpoint
Time Frame: 2 years
|
The primary objective of this study is to examine the performance of the STAR™ Ankle under actual conditions of use, employing the approved instructions for use, labeling, and instrumentation. The principal endpoint consists of evaluating the safety and effectiveness of the STAR™ Ankle. Overall patient success is defined as:
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary Endpoints
Time Frame: 2 years
|
In addition to the principal endpoint, information on the following efficacy outcomes will be assessed:
The following radiographic endpoints will be assessed by anterior/posterior and lateral radiographs by the treating surgeon and an independent radiographic reviewer:
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Stefan Maartense, MD, Stryker Nordic
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STAR 2 Year
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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