N/A
N=13
Compression Nail for Tibiocalcaneal Arthrodesis
Subtalar Arthritis · Ankle Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT03780452 ↗Enrolled (actual)
13
Serious AEs
27.3%
Results posted
May 2025
Primary outcome: Primary: Pain Assessment — 52.73; 33.00; 17.00; 21.25 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- novel dynamic compression intramedullary nail (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Assessment |
52.73; 33.00; 17.00; 21.25; 20.00; 34.00 | — |
| PRIMARY Functional Assessment |
48.18; 42.27; 14.55; 56.00; 77.85; 53.5 | — |
| PRIMARY Change in Functional Assessment |
24.74; 23.82; 27.46; 37.64; 40.56; 39.64 | — |
| PRIMARY Fusion, as Measured by Radiograph and CT Scan |
7; 1; 0 | — |
Summary
The purpose of this study is to determine the clinical efficacy of a novel dynamic compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis
Eligibility Criteria
Inclusion Criteria
- Over the age of 18
- Ankle and Subtalar arthritis
- Failed non-operative management
Exclusion Criteria
- Patients who do not meet the minimum age of 18 years.
- patients who are not eligible to undergo surgery
Data sourced from ClinicalTrials.gov (NCT03780452). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.