The Use of a Dynamic Compression Intramedullary Nail for Tibiotalocalcaneal Arthrodesis

NCT ID: NCT04784273

Last Updated: 2021-03-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-23
• Study Completion Date: 2023-09-30

Brief Summary

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

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.

Conditions

Ankle Arthritis; Foot Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

All study patients

Device - DynaNail - Utilization of a novel dynamic compression pseudoelastic intramedullary nail

Tibiotalocalcaneal Arthrodesis

Intervention Type: PROCEDURE

Tibiotalocalcaneal (TTC) arthrodesis with a novel dynamic compression intramedullary nail.

DynaNail

Intervention Type: DEVICE

Utilization of a novel dynamic compression pseudoelastic intramedullary nail

Interventions

Tibiotalocalcaneal Arthrodesis

Tibiotalocalcaneal (TTC) arthrodesis with a novel dynamic compression intramedullary nail.

Intervention Type: PROCEDURE

DynaNail

Utilization of a novel dynamic compression pseudoelastic intramedullary nail

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

MedShape, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashish B Shah, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kenneth Dupont, PhD, MS

Role: CONTACT

kenneth.dupont@medshape.com

6782353336

Melanese Leonard-Warren, RN, MSN

Role: CONTACT

mnleonard@uabmc.edu

2059752671

Facility Contacts

Melanese Leonard-Warren, RN, MSN

Role: primary

mnleonard@uabmc.edu

205-975-2671

Ashish Shah, MD

Role: backup

ashishshah@uabmc.edu

Other Identifiers

IRB-300002689

Identifier Type: -

Identifier Source: org_study_id