The Use of a Dynamic Compression Intramedullary Nail for Tibiotalocalcaneal Arthrodesis

Study Overview
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Brief Summary
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The purpose of this study is to determine the clinical efficacy of a novel sustained dynamic compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis.

Detailed Description
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This proposal is a collaborative effort between MedShape and the University of Alabama at Birmingham. This is a prospective investigation to assess the clinical outcomes of patients with a tibiotalocalcaneal arthrodesis with the sustained Dynamic Compression Intramedullary Nail (DynaNail). We are planning on enrolling 30 patients. 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 Visual Analog Scale (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. The following surgical procedure is standard of care. 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 and their splint will be removed. Non-weight bearing radiographs of the hind foot will be taken to assess the amount of travel of the compressive element. The patient will be placed in a non-weight bearing cast. The patient will then be asked to return in four weeks (6 weeks post-operatively). At this time additional non-weight bearing radiographs will be taken to assess the amount of travel of the compressive element. The patient will be asked to return at 12 weeks, 24 weeks, and one year after surgery. At 24 weeks, a CT scan will be obtained to assess healing and fusion. At each of these time-points, the same patient specific outcome questionnaires will be administered. 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 over age 18 who has ankle and subtalar arthritis and has failed nonoperative management. Typically, these patients have multiple medical comorbidities and therefore the exclusion criteria will be patients who are not healthy enough to undergo surgery. Additional exclusion criteria include non-English speakers, and patients that are blind, illiterate, or are prisoners. Patients of all racial, religious, and cultural backgrounds will be included in this study.

Official Title
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The Use of a Dynamic Compression Intramedullary Nail for Tibiotalocalcaneal Arthrodesis

Conditions
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Ankle Arthritis, Foot Arthritis

Intervention / Treatment
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* Procedure: Tibiotalocalcaneal Arthrodesis
* Device: DynaNail


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All study patients<br>Device - DynaNail - Utilization of a novel dynamic compression pseudoelastic intramedullary nail | Procedure: Tibiotalocalcaneal Arthrodesis<br>* Tibiotalocalcaneal (TTC) arthrodesis with a novel dynamic compression intramedullary nail.<br>Device: DynaNail<br>* Utilization of a novel dynamic compression pseudoelastic intramedullary nail<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion / Union | Joint Fusion, as measured by radiograph and CT scan | Time Frame: Pre-operative up to 1 year post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Function - SF-36 | Change in function as assessed by Short Form 36 | Pre-Operative up to one year post-surgery | 
| Function - FAAM | Change in function as assessed by Foot and Ankle Ability Measure | Pre-Operative up to one year post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subtalar Arthrodesis, Tibiotalar Arthrodesis, Sustained Dynamic Compression, Internal Fixation, Intramedullary Nail