Status:
COMPLETED
Evaluation of Trinity Evolution in Patients Undergoing Foot and Ankle Fusion
Lead Sponsor:
Orthofix Inc.
Conditions:
Tibiotalar Arthrodesis
Subtalar Arthrodesis
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to utilize Trinity Evolution as a graft source in foot/ankle fusions and to follow the subjects to measure the clinical outcomes and fusion rate. The hypothesis of the stu...
Detailed Description
Symptomatic arthritic conditions of the foot and ankle including osteoarthritis, post-traumatic arthritis, inflammatory arthropathies and others can be painful and disabling conditions that lead to a ...
Eligibility Criteria
Inclusion
- Foot and/or ankle pathology requiring fusion using open surgical technique with supplemental bone graft/substitute requiring one of the following procedures:
- Ankle joint fusion
- Subtalar fusion
- Calcaneocuboid fusion
- Talonavicular fusion
- Double fusions (talonavicular and calcaneocuboid joints)
- Triple fusions (subtalar, talonavicular, and calcaneocuboid joints)
- At least 18 years of age
- Willing and able to comply with the requirements of the protocol including follow-up requirements
- Willing and able to sign a study-specific informed consent.
Exclusion
- Use of any other bone graft or bone graft substitute in addition to or in place of Trinity Evolution at the time of surgery
- Use of adjunctive post-operative stimulation
- Active local or systemic infection
- Currently pregnant or considering becoming pregnant during the follow-up period
- Active malignancy or having been on chemotherapy of any kind for a malignancy in the past 1 year
- Immunosuppressive therapy of any kind within the past 1 year
- Has a known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (DMSO).
Key Trial Info
Start Date :
September 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT00988338
Start Date
September 1 2009
End Date
January 1 2013
Last Update
October 28 2021
Active Locations (10)
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1
Orthopaedic Associates of South Broward, PA
Hollywood, Florida, United States, 33021
2
Sinai Hospital of Baltimore / Rubin Institute for Advanced Orthopedics
Baltimore, Maryland, United States, 21215
3
New Mexico Orthopedics
Albuquerque, New Mexico, United States, 87106
4
OrthoCarolina Research Institute
Charlotte, North Carolina, United States, 28203