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Tibiotalar Arthrodesis
+5

Evaluation of Trinity Evolution in Patients Undergoing Foot and Ankle Fusion

Sponsored by Orthofix Inc.

About this trial

Last updated 4 years ago

Study ID

TY01AF

Status

Completed

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 12 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

- 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.

No

Exclusion Criteria

- 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).

Locations

Location

Status