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

NCT00586781 | Completed Phase 3

• 1 other identifier: Link-3
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Osteoarthritis; Post-Traumatic Arthritis; Rheumatoid Arthritis

Keywords

ankle replacement; end-stage arthritis of the ankle; degenerative ankle disease

Outcome Measures

Primary Outcomes (1)

• Safety endpoints to be measured are: • Device failure or device removal/revision • Radiographically confirmed loosening and migration • Complications

  12 months

Study Arms (1)

3

EXPERIMENTAL

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)

Interventions

Scandinavian Total Ankle Replacement (STAR) 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.

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Link America, Inc.: lead

Study Sites (5)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Orthopedic Associates of Dallas

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Roger A Mann, MD

  Roger A Mann, Inc

  PRINCIPAL INVESTIGATOR

• Michael J Coughlin, MD

  Foot and Ankle

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 4, 2008
• Study Start: September 1, 2001
• Primary Completion: December 1, 2006
• Last Updated: January 4, 2008

Record last verified: 2007-12

Locations

US (5)