Compression Nail for Tibiocalcaneal Arthrodesis

Use of Dynamic Intramedullary Compression Nail for Tibiocalcaneal Arthrodesis

The purpose of this study is to determine the clinical efficacy of a novel dynamic compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis

Study Overview

• Status: Recruiting
• Conditions: Ankle Arthritis; Subtalar Arthritis
• Intervention / Treatment: Device: novel dynamic compression intramedullary nail

Detailed Description

This proposal is a collaborative effort of MedShape Inc. It is a prospective investigation to assess the clinical outcomes of patients with a tibiotalocalcaneal arthrodesis with the Dynamic Compression Intramedullary Nail (DynaNail). We are planning to enroll 30 patients. The assignment of the device is at the discretion of the standard of care provider, not the study investigator.

Patients with end-stage tibiotalar (ankle) and talocalcaneal (subtalar) joint arthritis from any etiology will be asked to enroll in the study. After informed consent, the patients will be asked to complete the following patient reported outcomes questionnaires (standard of care for all patients in the Foot and Ankle section): 100mm VAS for pain, Short form-36 (SF-36), and the Foot and Ankle Ability Measure (FAAM). After informed consent, they will then be scheduled for surgery in a routine fashion. REDCap database will be used to allow on-line data entry.

The following surgical procedure steps and follow-ups are standard of care at the University of Alabama at Birmingham. The surgical procedure will involve both tibiotalar and talocalcaneal joint preparation through any approach (lateral, posterior, anterior with sinus tarsi). The use of supplemental bone graft is at the discretion of the treating surgeon but must be documented. The MedShape DynaNail will then be inserted according to the manufacturer's technique. The patient will be placed in a short leg splint and kept non-weight bearing. The patient will be discharged from the hospital when medically ready and follow-up in two weeks.

At two weeks, the patient will return to clinic for a standard of care visit and their splint will be removed. A non-weight bearing lateral radiograph of the hind foot will be taken to assess the amount of travel of the compressive element. This radiograph is not standard of care. The patient will be placed in a non-weight bearing cast. The patient will then be asked to return in two weeks (4 weeks post-operatively). This visit is not standard of care. At this time another non-weight bearing lateral radiograph will be taken to assess the amount of travel of the compressive element. The patient will be asked to return at 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery as is standard of care for this surgery. At each of these time-points, the same patient specific outcome questionnaires will be administered. For any non- standard of care radiographs patients will be asked to take a urine pregnancy test prior to any radiographs being taken.

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Ashish B Shah, M.D.; Phone Number: 205-930-8339; Email: ashishshah@uabmc.edu
• Study Contact Backup: Name: Aaradhana J Jha, M.D.; Phone Number: 617-378-5116; Email: aaradhana.jha@gmail.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Recruiting
      • University Of Alabama
      • Contact: Ashish Shah, MD; Phone Number: 205-930-6722; Email: ashishshah@uabmc.edu
      • Contact: felisa guess; Phone Number: 2059306722; Email: fguess@ubamc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tibiotalocalcaneal arthrodesis with DynaNail; Tibiotalocalcaneal arthrodesis with a novel dynamic compression intramedullary nail	Device: novel dynamic compression intramedullary nail; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 - 24 months postoperatively
functional assessment	Foot and Ankle Ability Measure (FAAM)	0 - 24 months postoperatively
Change in Functional Assessment	Short Form 36 (SF-36).	0 - 24 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 - 24 months postoperative

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: MedShape, Inc
• Investigators: Principal Investigator: ashish shah, md, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2020
• Primary Completion (Estimated): January 10, 2025
• Study Completion (Estimated): January 10, 2025

Study Registration Dates

• First Submitted: December 17, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: arthrodesis; intramedullary nail; subtalar; tibiotalar
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: IRB-300002689

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No