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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01284283
Recruitment Status : Recruiting
First Posted : January 26, 2011
Last Update Posted : April 6, 2018
Information provided by (Responsible Party):
Stryker Trauma GmbH

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
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 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01284283

Contact: Lindsay Mattfolk

United States, Arizona
The CORE Institute Recruiting
Phoenix, Arizona, United States, 85023
Contact: Susan Mauro, RN   
Principal Investigator: Jeffrey McAlister, DPM         
Sub-Investigator: Mark Campbell, MD         
United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: David Thordarson         
Principal Investigator: David Thordarson, MD         
Palo Alto Medical Research Foundation (Sutter Health) Recruiting
Palo Alto, California, United States
Contact: Shannon Rush, DPM         
Principal Investigator: Shannon Rush, DPM         
Kaiser Permanente Completed
San Francisco, California, United States, 94118
United States, Michigan
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48085
Contact: Kristy McCandlish   
Principal Investigator: Allen Grant, MD         
United States, Nevada
Reno Orthopaedic Center Recruiting
Reno, Nevada, United States
Contact: Sara DePaoli   
Principal Investigator: Gregg Lundeen, MD         
Sub-Investigator: Scott Whitlow, MD         
United States, New York
Kenneth Mroczek, MD-NYU Recruiting
New York, New York, United States, 10003
Contact: Ariel Aponte   
Principal Investigator: Kenneth Mroczek, MD         
Sub-Investigator: Cary Chapman, MD         
Sub-Investigator: Steven Sheskier, MD         
United States, Pennsylvania
University of Pennsylvania Health Systems-PA Foot and Ankle Surgeons Recruiting
Philadelphia, Pennsylvania, United States, 19106
Contact: Aliaksei Basatski   
Principal Investigator: Keith L Wapner, MD         
Sub-Investigator: David Farber, MD         
Sub-Investigator: Wen Chao, MD         
United States, Texas
Center for Foot and Ankle Restoration Completed
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Stryker Trauma GmbH
Study Director: Richard Jay, DPM Stryker Nordic

Responsible Party: Stryker Trauma GmbH Identifier: NCT01284283     History of Changes
Other Study ID Numbers: STAR 2 Year
First Posted: January 26, 2011    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Stryker Trauma GmbH:
Rheumatoid Arthrosis
Arthritic Joint
Rheumatoid Arthritis
Total Ankle Replacement

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