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

Rheumatoid Arthritis Clinical Trial

Official title:

Investigational Device Exemption for the Scandinavian Total Ankle Replacement (STAR) - Bilateral Arm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00586781
• Other study ID #: Link-3
• Status: Completed
• Phase: Phase 3
• First received: December 21, 2007
• Last updated: December 21, 2007
• Start date: September 2001

Study information

• Verified date: December 2007
• Source: Link America, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Osteoarthritis
• Post-Traumatic Arthritis
• Rheumatoid Arthritis

Intervention

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.

Locations

Country	Name	City	State
United States	Orthopedic Associates of Dallas	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Iowa	Iowa City	Iowa
United States	Mayo Clinic	Jacksonville	Florida
United States	Kansas University Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Link America, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety endpoints to be measured are: • Device failure or device removal/revision • Radiographically confirmed loosening and migration • Complications		12 months	Yes