The Use of a Dynamic Compression Intramedullary Nail for Tibiotalocalcaneal Arthrodesis
1 other identifier
observational
30
1 country
1
Brief Summary
The purpose of this study is to determine the clinical efficacy of a novel dynamic compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 22, 2017
CompletedFirst Submitted
Initial submission to the registry
September 25, 2018
CompletedFirst Posted
Study publicly available on registry
September 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedMarch 5, 2021
February 1, 2021
4.9 years
September 25, 2018
March 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fusion
Fusion, as measured by radiograph and CT scan
Pre-operative up to 2 years post surgery
Secondary Outcomes (3)
Pain - VAS
Pre-operative up to 2 years post surgery
Function - SF-36
Pre-operative up to 2 years post surgery
Function - FAAM
Pre-operative up to 2 years post surgery
Interventions
Tibiotalocalcaneal (TTC) arthrodesis with a novel dynamic compression intramedullary nail.
Utilization of a novel dynamic compression pseudoelastic intramedullary nail
Eligibility Criteria
Patients will be identified in the clinic by an attending orthopaedic foot and ankle surgeon or his physician assistant based on clinical exam and radiographic findings. Inclusion criteria include anyone age 18 and over who has ankle and subtalar arthritis and has failed nonoperative management. Typically, these patients have multiple medical comorbidities and therefore exclusion criteria will include patients who are not healthy enough to undergo surgery. Patients of all racial, religious, and cultural backgrounds will be included in this study. Approximately 30 patients will be recruited for the study.
You may qualify if:
- years of age or older
- Ankle and Subtalar arthritis
- Failed non-operative management
- Able to understand the requirements of the study, provide written consent, and willing to comply with study protocol
You may not qualify if:
- Patients who do not meet the minimum age of 18 years
- Patients not healthy enough to undergo surgery
- Investigator determines that the subject is unlikely to comply with the requirements of the study
- Non-English speaker
- Blind
- Illiterate
- Prisoner
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedShape, Inclead
- Saint Alphonsus Medical Groupcollaborator
Study Sites (1)
Saint Alphonsus Medical Group Orthopedics Coughlin Foot and Ankle Clinic
Boise, Idaho, 83706, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher B Hirose, MD
Saint Alphonsus Medical Group Orthopedics Coughlin Foot and Ankle Clinic
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2018
First Posted
September 26, 2018
Study Start
May 22, 2017
Primary Completion
May 1, 2022
Study Completion
May 1, 2022
Last Updated
March 5, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share