Evaluation of Trinity Evolution in Patients Undergoing Foot and Ankle Fusion
Completed
Conditions studied: Tibiotalar Arthrodesis, Subtalar Arthrodesis, Calcaneocuboid Arthrodesis, Talonavicular Arthrodesis, Double Arthrodesis (i.e. Calcaneocuboid and Talonavicular), Triple Arthrodesis (i.e. Subtalar, Calcaneocuboid, and Talonavicular)
In brief
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 study is that Trinity Evolution will result in fusion rates and clinical outcomes similar to those obtained from autograft and other routinely used allograft materials; these include: fusion, improvement in pain, improvement in function, and absence of adverse events related to the use of the graft source.
Key facts
- Study ID
- NCT00988338
- Run by
- Orthofix Inc.
- People needed
- 106
- Starts
- 2009-09-01
- Expected to finish
- 2013-01-01
- Last updated by the study team
- 2021-10-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- Orthopaedic Associates of South Broward, PA — Hollywood, Florida, United States
- Sinai Hospital of Baltimore / Rubin Institute for Advanced Orthopedics — Baltimore, Maryland, United States
- New Mexico Orthopedics — Albuquerque, New Mexico, United States
- OrthoCarolina Research Institute — Charlotte, North Carolina, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Ohio Orthopedic Center of Excellence — Upper Arlington, Ohio, United States
- The Western Pennsylvania Hospital — Pittsburgh, Pennsylvania, United States
- University Orthopedics Center — State College, Pennsylvania, United States
- Central Tennessee Foot and Ankle Center — Sparta, Tennessee, United States
- Franciscan Foot and Ankle Specialists — Burien, Washington, United States
Full record on ClinicalTrials.gov
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