Compression Nail for Tibiocalcaneal Arthrodesis

NCT03780452 | Completed Results FDA Device

• 1 other identifier: IRB-300002689
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 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

Conditions

Subtalar Arthritis; Ankle Arthritis

Keywords

intramedullary nail; arthrodesis; subtalar; tibiotalar

Outcome Measures

Primary Outcomes (4)

• Pain Assessment

  Visual Analog Scale (VAS). Patients will disclose their pain level using the Visual Analog Scale, which measures pain on a scale of 0 - 100, with 0 indicating no pain and 100 indicating severe pain.

  0 - 12 months postoperatively

• Functional Assessment

  Foot and Ankle Ability Measure (FAAM). The FAAM is made up of a 21-item activity of daily living (ADL) and and 8-item sports subscale, which are combined to form a single total score. The ADL subscale ranges from 0 to 84 and the sports from 0 to 32. The total score is a calculated by adding the two subscores together and then reporting as a percentage of the total possible score (116). The percent score range is from 0% to 100%. For interpretation of the results a score closure to 100% is considered greater function.

  0 - 12 months postoperatively

• Change in Functional Assessment

  The Short Form 36 (SF-36) is a total of 36 questions covering 8 domains of health: (1) limitations in physical activities, (2) limitations in social activities, (3) limitations in usual role activities due to physical health problems, (4) bodily pain, (5) general mental health, (6) Limitations in usual role activities due to emotional problems, (7) Vitality, and (8) General health perceptions. The domain scores are added together for a total score. The total is a reported as a percentage from 0% to 100% with 50 serving as the normative value. Higher scores represent a greater level of functioning.

  0 - 12 months postoperatively

• Fusion, as Measured by Radiograph and CT Scan

  radiographs taken Pre-operatively, 2 weeks, 4 weeks, 6 weeks, 3 Months, 6 Months, 12 Months and 24 Months. A CT scan will be done at 6 months.

  0 - 12 months postoperative

Study Arms (1)

Tibiotalocalcaneal arthrodesis with DynaNail

Tibiotalocalcaneal arthrodesis with a novel dynamic compression intramedullary nail

Device: novel dynamic compression intramedullary nail

Interventions

novel dynamic compression intramedullary nail DEVICE

Tibiotalocalcaneal (TTC) arthrodesis with a novel dynamic compression intramedullary nail. The assignment of the device is at the discretion of the standard of care provider, not the study investigator.

Tibiotalocalcaneal arthrodesis with DynaNail

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be identified in the clinic by an attending orthopaedic foot and ankle surgeon, his clinical fellow, or his physician assistant based on clinical exam and radiographic findings. Inclusion criteria include anyone over age 18 who has ankle and subtalar arthritis and has failed nonoperative management. Typically, these patients have multiple medical comorbidities and therefore the only exclusion criteria will be patients who are not healthy enough to undergo surgery. Patients of all racial, religious, and cultural backgrounds will be included in this study.

You may qualify if:

• Over the age of 18
• Ankle and Subtalar arthritis
• Failed non-operative management

You may not qualify if:

• Patients who do not meet the minimum age of 18 years.
• patients who are not eligible to undergo surgery

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• MedShape, Inc: collaborator

Study Sites (1)

University of Alabama

Birmingham, Alabama, 35205, United States

Location

MeSH Terms

Conditions

Ankylosis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Dr. Ashish Shah
• Organization: UAB Department of Orthopaedic Surgery

ashishshah@uabmc.edu

(205) 930-8339

Study Officials

• ashish shah, md

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 19, 2018
• Study Start: November 15, 2020
• Primary Completion: July 10, 2024
• Study Completion: July 10, 2024
• Last Updated: May 31, 2025
• Results First Posted: May 22, 2025

Record last verified: 2025-05

Locations

US (1)