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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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Stryker Trauma GmbH
Information provided by (Responsible Party):
Stryker Trauma GmbH Identifier:
First received: November 2, 2010
Last updated: September 30, 2016
Last verified: September 2016
This post-approval study is being conducted to examine the performance of the STAR Ankle under actual conditions of use.

Condition Intervention
Primary Arthrosis
Post Traumatic Arthritis
Rheumatoid Arthritis
Device: Scandinavian Total Ankle Replacement System (STAR Ankle)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 2-Year Post-Approval Study to Investigate the STAR Ankle Under Actual Conditions of Use

Resource links provided by NLM:

Further study details as provided by Stryker Trauma GmbH:

Primary Outcome Measures:
  • Primary Endpoint [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

    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:
  • Secondary Endpoints [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    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

Estimated Enrollment: 98
Study Start Date: November 2009
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Device: Scandinavian Total Ankle Replacement System (STAR Ankle)
Device: Scandinavian Total Ankle Replacement System (STAR Ankle)
For total ankle replacement
Other Name: STAR

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.

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01284283

Contact: Rebecca Gibson

United States, California
Kaiser Permanente Recruiting
San Francisco, California, United States, 94118
Contact: Eva Greenstein   
Contact: Alfonso Gutierrez   
Principal Investigator: John M Schuberth, DPM         
Sub-Investigator: Christy King, DPM         
United States, Michigan
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48085
Contact: Kristy McCandlish   
Principal Investigator: Allen Grant, MD         
United States, New York
Kenneth Mroczek, MD-NYU Recruiting
New York City, 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: Kim Lacy   
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 Active, not recruiting
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Stryker Trauma GmbH
  More Information

Responsible Party: Stryker Trauma GmbH Identifier: NCT01284283     History of Changes
Other Study ID Numbers: STAR 2 Year 
Study First Received: November 2, 2010
Last Updated: September 30, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Stryker Trauma GmbH:
Rheumatoid Arthrosis
Arthritic joint
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases processed this record on October 21, 2016