Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04784156 |
| Other study ID # |
Pro00104048 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 2021 |
| Est. completion date |
March 2024 |
Study information
| Verified date |
March 2021 |
| Source |
MedShape, Inc |
| Contact |
Kenneth 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 sustained
compression intramedullary nail for subtalar (talocalcaneal) arthrodesis.
Description:
This proposal is a collaborative effort between MedShape and the Medical University of South
Carolina. This is a prospective investigation to assess the clinical outcomes of patients
with a subtalar arthrodesis with the Sustained Dynamic Compression Intramedullary Nail
(DynaNail Mini). The study plan is to enroll 60 patients.
Patients with end-stage 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 as part of the Surgical Outcomes
System (SOS) Global Registry: Visual Analog Scale (VAS) for pain, Veterans RAND 12 Item
Health Survey for function, Foot Function Index - Revised for function and pain, the Foot and
Ankle Ability Measure (FAAM) for function, and the American Orthopaedic Foot and Ankle
Society (AOFAS) scales for pain, function, and alignment. 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
subtalar (talocalcaneal) joint preparation through a lateral approach. The use of
supplemental bone graft is at the discretion of the treating surgeon but must be documented.
The MedShape DynaNail Mini 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.
The patient will return to clinic for visits at the following intervals after surgery: 6 (+/-
1) weeks, 14 (+/- 1) weeks, 6 months (+/- 2 weeks), and 12 months (+/- 2 weeks). At each of
these time points, the same SOS patient specific outcome questionnaires will be administered.
3-view X-rays will be taken at each of these visits to assess the amount of travel of the
Mini compressive element. At 15 (+/- 1) weeks post-op, a CT scan will be obtained to assess
healing. Additionally, a radiographic and clinical follow-up form will be filled out at each
of the following follow-up visits: 6 weeks, 14 weeks, 6 months, and 1 year.
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 end-stage 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. Additionally, pregnant women will be excluded. Patients
of all racial, religious, and cultural backgrounds will be included in this study.
