Use of a Dynamic Compression Intramedullary Nail for Tibiotalocalcaneal Arthrodesis
NCT ID: NCT03747952
Last Updated: 2021-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2019-05-14
2024-05-31
Brief Summary
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Detailed Description
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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 6 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Tibiotalocalcaneal arthrodesis
Tibiotalocalcaneal (TTC) arthrodesis with a novel dynamic compression intramedullary nail.
DynaNail
Utilization of a novel dynamic compression pseudoelastic intramedullary nail
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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The University of Texas Medical Branch, Galveston
OTHER
MedShape, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Vinod K Panchbhavi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas
Locations
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The University of Texas Medical Branch at Galveston
Galveston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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18-0050
Identifier Type: -
Identifier Source: org_study_id
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