Clinical trial NCT04784273: The Use of a Dynamic Compression Intramedullary Nail for Tibiotalocalcaneal Arthrodesis
Official title: The Use of a Dynamic Compression Intramedullary Nail for Tibiotalocalcaneal Arthrodesis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ankle Arthritis
Foot Arthritis
Keywords: Subtalar Arthrodesis
Tibiotalar Arthrodesis
Sustained Dynamic Compression
Internal Fixation
Intramedullary Nail
Lead sponsor: MedShape, Inc
Sponsor class: INDUSTRY
Collaborators: name: University of Alabama at Birmingham
First posted: 2021-03-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
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 age 18 and over who has ankle and subtalar arthritis and has failed nonoperative management. Typically, these patients have multiple medical comorbidities and therefore exclusion criteria will include 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.

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.

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

Primary outcomes:
measure: Fusion / Union
timeFrame: Time Frame: Pre-operative up to 1 year post surgery
Secondary outcomes:
measure: Pain - VAS
timeFrame: Pre-Operative up to one year post-surgery
measure: Function - SF-36
timeFrame: Pre-Operative up to one year post-surgery
measure: Function - FAAM
timeFrame: Pre-Operative up to one year post-surgery
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Ashish B Shah, MD
role: PRINCIPAL_INVESTIGATOR
References: