Study of the Scandinavian Total Ankle Replacement (STAR) for the Treatment of Bilateral Degenerative Ankle Disease

This study has been completed.
Sponsor:
Information provided by:
Link America, Inc.
ClinicalTrials.gov Identifier:
NCT00586781
First received: December 21, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

The purpose of this study is to evaluate the safety of the S.T.A.R. device for patients with bilateral disease.


Condition Intervention Phase
Osteoarthritis
Post-Traumatic Arthritis
Rheumatoid Arthritis
Device: Scandinavian Total Ankle Replacement (STAR)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigational Device Exemption for the Scandinavian Total Ankle Replacement (STAR) - Bilateral Arm

Resource links provided by NLM:


Further study details as provided by Link America, Inc.:

Primary Outcome Measures:
  • Safety endpoints to be measured are: • Device failure or device removal/revision • Radiographically confirmed loosening and migration • Complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 21
Study Start Date: September 2001
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3
The S.T.A.R. ankle system is the study device. The device has three parts: two metal bearing surfaces (cobalt-chromium alloy) plates with bars that fit into the bone and one plastic (polyethylene) spacer that moves between the metal plates like a ball bearing. The materials in the S.T.A.R. device are the same materials used in total hip and knee implants. Both ankles of every subject will be treated with the STAR ankle.
Device: Scandinavian Total Ankle Replacement (STAR)
The device has three parts: two metal bearing surfaces (cobalt-chromium alloy) plates with bars that fit into the bone and one plastic (polyethylene) spacer that moves between the metal plates like a ball bearing. The materials in the S.T.A.R. device are the same materials used in total hip and knee implants.

Detailed Description:

The specific objectives are to show that the safety data of the S.T.A.R. ankle arthroplasty is similar for treatment of single ankle disease (as defined in the pivotal study) and bilateral ankle disease. The bilateral disease may be identified at the time of enrollment or may have progressed after enrollment and treatment of the first ankle in the pivotal study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Moderate or severe pain, loss of mobility and function of the ankle
  • Primary arthrosis, post traumatic arthrosis or rheumatoid arthrosis
  • At least six months of conservative treatment for severe ankle conditions
  • Bilateral ankle disease that have not been enrolled in the pivotal study or single ankle disease and enrolled in the pivotal study but have subsequently developed ankle disease in the contralateral ankle and require surgical intervention
  • Willing and able to give informed consent

Exclusion Criteria:

  • Patients who have not reached skeletal maturity
  • Active or prior deep infection in the 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 or prior drug abuse or alcoholism
  • Any physical condition precluding major 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
  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 ClinicalTrials.gov identifier: NCT00586781

Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Texas
Orthopedic Associates of Dallas
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Link America, Inc.
Investigators
Principal Investigator: Roger A Mann, MD Roger A Mann, Inc
Principal Investigator: Michael J Coughlin, MD Foot and Ankle
  More Information

No publications provided

Responsible Party: Andrew Greenberg, President, Link America, Inc
ClinicalTrials.gov Identifier: NCT00586781     History of Changes
Other Study ID Numbers: Link-3
Study First Received: December 21, 2007
Last Updated: December 21, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Link America, Inc.:
ankle replacement
end-stage arthritis of the ankle
degenerative ankle disease

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

ClinicalTrials.gov processed this record on July 24, 2014