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

This study is currently recruiting participants.
Verified March 2012 by Small Bone Innovations, Inc.
Sponsor:
Information provided by (Responsible Party):
Small Bone Innovations, Inc.
ClinicalTrials.gov Identifier:
NCT01284283
First received: November 2, 2010
Last updated: March 1, 2012
Last verified: March 2012
History of Changes
  Purpose

The purpose of this study is to examine how well the Scandinavian Total Ankle Replacement (STAR) performs using new instrumentation and a new surgeon training program. Results of this study will be compared to the results from the original clinical trial.


Condition Intervention
Primary Arthrosis
Post Traumatic Arthritis
Rheumatoid Arthritis
Osteoarthritis
 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:

U.S. FDA Resources

Further study details as provided by Small Bone Innovations, Inc.:

Primary Outcome Measures:
  • The principal endpoint consists of evaluating the safety and effectiveness of the STAR Ankle using the same composite definition of patient success used in the IDE study. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • American Orthopaedic Foot and Ankle Society Score questionnaire will be used to evaluate and monitor the progress of patients following foot and ankle surgery. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 98
Study Start Date: November 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single
Single Arm
 Device: Scandinavian Total Ankle Replacement System (STAR Ankle)
For total ankle replacement
Other Name: STAR

Detailed Description:

STAR 2 year study is a prospective, multi-center, single-arm study.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284283

Contacts
Contact: Abigail Allen 202-552-5800 aallen@mcra.com

Locations
United States, New York
Kenneth Mroczek, MD-NYU Recruiting
New York City, New York, United States, 10003
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
Principal Investigator: Keith L Wapner, MD            
United States, Texas
Charles E. Cook, MD Recruiting
Dallas, Texas, United States, 75231
Principal Investigator: Charles E Cook, MD            
Sponsors and Collaborators
Small Bone Innovations, Inc.
Investigators
Study Director: Jim O'Connor Small Bone Innovations
  More Information

No publications provided

Responsible Party: Small Bone Innovations, Inc.
ClinicalTrials.gov Identifier: NCT01284283     History of Changes
Other Study ID Numbers: STAR 2 Year
Study First Received: November 2, 2010
Last Updated: March 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Small Bone Innovations, Inc.:
Arthrosis
Rheumatoid Arthrosis
Arthritic joint
Rheumatoid Arthritis
Osteoarthritis

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

ClinicalTrials.gov processed this record on May 22, 2013