Clinical trial NCT03686241: 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: Tibiotalocalcaneal arthrodesis
Intramedullary Nail
Sustained Compression
Lead sponsor: MedShape, Inc
Sponsor class: INDUSTRY
Collaborators: name: Saint Alphonsus Medical Group
First posted: 2018-09-26
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 dynamic compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis.

Detailed description: This proposal is a collaborative effort between MedShape and the Saint Alphonsus Medical Group Foot and Ankle Clinic. 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 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 two weeks (4 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 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery. At 3 months, a CT scan will be obtained to assess healing. 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:

* 18 years of age or older
* Ankle and Subtalar arthritis
* Failed non-operative management
* Able to understand the requirements of the study, provide written consent, and willing to comply with study protocol

Exclusion Criteria:

* Patients who do not meet the minimum age of 18 years
* Patients not healthy enough to undergo surgery
* 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
timeFrame: Pre-operative up to 2 years post surgery
Secondary outcomes:
measure: Pain - VAS
timeFrame: Pre-operative up to 2 years post surgery
measure: Function - SF-36
timeFrame: Pre-operative up to 2 years post surgery
measure: Function - FAAM
timeFrame: Pre-operative up to 2 years post surgery
Other outcomes:
Locations:
city: Boise
country: United States
facility: Saint Alphonsus Medical Group Orthopedics Coughlin Foot and Ankle Clinic
state: Idaho
Study officials:
affiliation: Saint Alphonsus Medical Group Orthopedics Coughlin Foot and Ankle Clinic
name: Christopher B Hirose, MD
role: PRINCIPAL_INVESTIGATOR
References: