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

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ClinicalTrials.gov Identifier: NCT01284283
Recruitment Status : Active, not recruiting
First Posted : January 26, 2011
Last Update Posted : November 6, 2020
Sponsor:
Information provided by (Responsible Party):
Stryker Trauma GmbH

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

Condition or disease Intervention/treatment Phase
Primary Arthrosis Post Traumatic Arthritis Rheumatoid Arthritis Osteoarthritis Device: Scandinavian Total Ankle Replacement System (STAR Ankle) Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 2-Year Post-Approval Study to Investigate the STAR Ankle Under Actual Conditions of Use
Study Start Date : November 2009
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

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Arms and Interventions
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Arm Intervention/treatment
Single
Device: Scandinavian Total Ankle Replacement System (STAR Ankle)
 Device: Scandinavian Total Ankle Replacement System (STAR Ankle)
For total ankle replacement
Other Name: STAR


Outcome Measures
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Primary Outcome Measures :
  1. 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:

    1. ≥ 40 point improvement in total Buechel-Pappas Scale score
    2. No device failures
    3. Radiographic success (no clinically significant radiographic evidence of loosening, tilting or migration > 4mm)
    4. No major complications


Secondary Outcome Measures :
  1. Secondary Endpoints [ Time Frame: 2 years ]

    In addition to the principal endpoint, information on the following efficacy outcomes will be assessed:

    • Total Buechel-Pappas Scale score
    • Pain Visual Analog Scale
    • Quality of Life
    • American Orthopaedic Foot & Ankle Society (AOFAS) Ankle Hindfoot Scale

    The following radiographic endpoints will be assessed by anterior/posterior and lateral radiographs by the treating surgeon and an independent radiographic reviewer:

    • Radiolucency
    • Migration


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT01284283


Locations
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United States, Arizona
The CORE Institute
Phoenix, Arizona, United States, 85023
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Palo Alto Medical Research Foundation (Sutter Health)
Palo Alto, California, United States, 94301
Kaiser Permanente
San Francisco, California, United States, 94118
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48085
United States, Nevada
Reno Orthopaedic Center
Reno, Nevada, United States, 89503
United States, New York
Kenneth Mroczek, MD-NYU
New York, New York, United States, 10003
United States, Pennsylvania
University of Pennsylvania Health Systems-PA Foot and Ankle Surgeons
Philadelphia, Pennsylvania, United States, 19106
United States, Texas
Center for Foot and Ankle Restoration
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Stryker Trauma GmbH
Investigators
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Study Director: Stefan Maartense, MD Stryker Nordic
More Information
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Responsible Party: Stryker Trauma GmbH
ClinicalTrials.gov Identifier: NCT01284283    
Other Study ID Numbers: STAR 2 Year
First Posted: January 26, 2011    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Stryker Trauma GmbH:
Arthrosis
Rheumatoid Arthrosis
Arthritic Joint
 Rheumatoid Arthritis
Osteoarthritis
Total Ankle Replacement
Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases