Ankle Arthritis Clinical Trial
Official title:
The Use of a Dynamic Compression Intramedullary Nail for Tibiotalocalcaneal Arthrodesis
The purpose of this study is to determine the clinical efficacy of a novel sustained dynamic compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | September 2023 |
Est. primary completion date | September 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Meets indications for TTC arthrodesis and receives the DynaNail implant - Able to understand the requirements of the study, provide a written consent, and willing to comply with the study protocol - 18 years of age or older Exclusion Criteria: - Investigator determines that the subject is unlikely to comply with the requirements of the study - Non-English speaker - Blind - Illiterate - Prisoner |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
MedShape, Inc | University of Alabama at Birmingham |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fusion / Union | Joint Fusion, as measured by radiograph and CT scan | Time Frame: Pre-operative up to 1 year post surgery | |
Secondary | Pain - VAS | Change in pain as assessed by Visual Analog Scale. The scale consists of a 100 mm straight line, with patients asked to mark a dot along the line their severity level of pain, with one end representing "the worst pain imaginable" and the other end representing "no pain". "No pain" is a score of 0, with "the worst pain imaginable" representing a score of 100. The quantitative distances are grouped into the following categories: 0-4 mm = no pain, 5-44 mm = mild pain, 45-74 mm = moderate pain, and 75-100 mm = severe pain. | Pre-Operative up to one year post-surgery | |
Secondary | Function - SF-36 | Change in function as assessed by Short Form 36 | Pre-Operative up to one year post-surgery | |
Secondary | Function - FAAM | Change in function as assessed by Foot and Ankle Ability Measure | Pre-Operative up to one year post-surgery |
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