The Use of a Dynamic Compression Intramedullary Nail for Tibiotalocalcaneal Arthrodesis
Condition: Ankle Arthritis
MeSH terms: Arthritis
Study type: Observational

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

Detailed description: 
      This proposal is a collaborative effort of MedShape. This 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 on enrolling 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 Duke
      University. 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
      3 months, a CT scan will be obtained to assess healing. This is standard of care at Duke
      University. 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
      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. Approximately 30 patients will be recruited for the study.
    

Intervention name(s): Procedure/Surgery
Intervention type(s): Device
Intervention description(s): 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.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        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 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. Approximately 30 patients will be recruited for
        the study.