Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04831645 |
| Other study ID # |
MedShape011221 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 24, 2021 |
| Est. completion date |
May 24, 2024 |
Study information
| Verified date |
April 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 sustained dynamic
compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis utilizing
longitudinal weight-bearing computed tomographic imaging. Of particular focus will be
assessment of compressive element recovery and its relation to fusion development over time
and weight-bearing status. Additionally, the study will incorporate longitudinal fusion
assessment to evaluate differences between three-dimensional weight-bearing computed
tomography (WBCT) scans and two-dimensional radiographs (X-rays) at multiple points of the
fusion process. Finally, the study will evaluate the differences in WBCT-based fusion
assessment between automated and manual methodologies for fusion area calculation.
Description:
This study is a collaborative effort between the Orthopedic Foot and Ankle Center, MedShape,
Inc, and CurveBeam. This is a prospective investigation to assess the clinical outcomes of
patients with a tibiotalocalcaneal arthrodesis with the Sustained Dynamic Compression
Intramedullary Nail (DynaNail), including longitudinal assessment with weight-bearing CT. The
investigators plan to enroll 45 patients. No placebo control will be used, as there is no
other IM nail available capable of providing sustained compression. Additionally, given that
many patients receiving this treatment have had prior failed treatments and face poor
alternatives such as amputation, using a prior-generation IM nail as a control treatment
would be unethical.
Design:
This is a prospective, single-group study. Patients of the Orthopedic Foot and Ankle Center
who are scheduled to undergo TTC arthrodesis will be screened for eligibility and informed
consent will be obtained from those who meet the inclusion/exclusion criteria. Subjects will
be assessed pre-operatively and then at five post-operative intervals: 1 week, 6 weeks, 3
months, 6 months, and 12 months. A WBCT scan will be obtained at each interval.
Selection of Subjects:
Patients will be identified in the clinic by an attending orthopaedic foot and ankle surgeon
or his/her physician assistant based on clinical exam and radiographic findings. Patients
will be screened for eligibility by the research coordinator/ key personnel in close
coordination with the surgeon and co-investigator.
Pre-operative Questionnaire:
After informed consent, the patients will be asked to complete patient reported outcomes
questionnaires that are part of the SOS Registry associated with function and pain, including
VAS, VR-12, FFI-R, FAAM, AOS, and AOFAS. The patients will also be asked to provide
information related to prior medical history (including potential co-morbidities associated
with non-union, i.e. tobacco usage, neuropathy, renal disease, obesity, etc.) and surgical
history of the subject lower extremity.
Surgery:
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 initially. The patient will be discharged from the hospital when
medically ready. Weight-bearing will start at seven weeks post-surgery.
Follow-Up Visits and Questionnaires:
The patient will return to clinic for visits at the following intervals after surgery: 1
week, 6 weeks, 3 months, 6 months, and 12 months. At each of these time points, a clinical
exam will be conducted, and SOS patient questionnaires will be administered, as well as a
radiographic and clinical follow-up form. Additionally, radiograph and weight-bearing CT
imaging will be obtained of both the ankle and subtalar joints. At 3 months and 12 months
post-op, all X-ray and CT images will be de-identified, burned to a DVD, and copies will be
sent to both co-sponsors.
