Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT03686241 |
Other study ID # |
SARMC-SPS207720 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
May 22, 2017 |
Est. completion date |
May 2022 |
Study information
Verified date |
February 2021 |
Source |
MedShape, Inc |
Contact |
Kenneth M Dupont, Ph.D. |
Phone |
6782353336 |
Email |
kenneth.dupont[@]medshape.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The purpose of this study is to determine the clinical efficacy of a novel dynamic
compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis.
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.