Use of a Sustained Dynamic Compression Intramedullary Nail for Subtalar Arthrodesis

NCT ID: NCT04784156

Last Updated: 2021-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2024-03-31

Brief Summary

The purpose of this study is to determine the clinical efficacy of a novel dynamic sustained compression intramedullary nail for subtalar (talocalcaneal) arthrodesis.

Detailed 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.

Conditions

Foot Arthritis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

All study patients

All study patients will be in one group.

Interventions:

Procedure: Subtalar (Talocalcaneal) arthrodesis Device: DynaNail Mini

Subtalar (Talocalcaneal) Arthrodesis

Intervention Type: PROCEDURE

Subtalar (Talocalcaneal) arthrodesis with a novel sustained dynamic compression intramedullary nail

DynaNail Mini

Intervention Type: DEVICE

Utilization of a novel sustained dynamic compression pseudoelastic intramedullary nail

Interventions

Subtalar (Talocalcaneal) Arthrodesis

Subtalar (Talocalcaneal) arthrodesis with a novel sustained dynamic compression intramedullary nail

Intervention Type: PROCEDURE

DynaNail Mini

Utilization of a novel sustained dynamic compression pseudoelastic intramedullary nail

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• End-stage talocalcaneal (subtalar) joint arthritis from any etiology will be eligible to enroll in the study
• Meets indications for subtalar arthrodesis to receive the DynaNail Mini implant
• Able to understand the requirements of the study, provide a written consent, and willing to comply with the study protocol
• 18 years of age or older

Exclusion Criteria

• Investigator determines that the subject is unlikely to comply with the requirements of the study
• Non-English speaker
• Blind
• Illiterate
• Prisoner
• Pregnant women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: collaborator

MedShape, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Gross, MD

Role: PRINCIPAL_INVESTIGATOR

ASSOCIATE PROFESSOR

Locations

The Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Central Contacts

Kenneth Dupont, Ph.D.

Role: CONTACT

Kenneth.dupont@medshape.com

6782353336

Caroline Hoch

Role: CONTACT

hoch@musc.edu

9193897136

Facility Contacts

Caroline Hoch

Role: primary

hoch@musc.edu

919-389-7136

Other Identifiers

Pro00104048

Identifier Type: -

Identifier Source: org_study_id