The Use of a Sustained Dynamic Compression Intramedullary Nail for Subtalar Arthrodesis

The Use of a Sustained Dynamic Compression Intramedullary Nail for Subtalar Arthrodesis

Sponsors

Lead Sponsor: MedShape, Inc

Collaborator: University of California, Davis

Source MedShape, Inc
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 University of California, Davis Medical Center. 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.

Overall Status Recruiting
Start Date April 2, 2020
Completion Date April 2, 2024
Primary Completion Date April 2, 2024
Study Type Observational
Primary Outcome
Measure Time Frame
Fusion From surgery up to one year post-surgery
Secondary Outcome
Measure Time Frame
Pain - VAS Pre-Operative up to one year post-surgery
Veterans RAND 12 Item Health Survey (VR-12) Pre-Operative up to one year post-surgery
Foot Function Index - Revised (FFI-R) Pre-Operative up to one year post-surgery
Foot and Ankle Ability Measure (FAAM) Pre-Operative up to one year post-surgery
American Orthopaedic Foot and Ankle Society Scales (AOFAS) Pre-Operative up to one year post-surgery
Enrollment 60
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Subtalar (Talocalcaneal) arthrodesis

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

Arm Group Label: All study patients

Intervention Type: Device

Intervention Name: DynaNail Mini

Description: Utilization of a novel sustained dynamic compression pseudoelastic intramedullary nail

Arm Group Label: All study patients

Eligibility

Sampling Method: Non-Probability Sample

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Christopher Kreulen, MD, MS Principal Investigator University of California, Davis
Overall Contact

Last Name: Kenneth M Dupont, PhD, MS

Phone: 6782353336

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: University of California, Davis Medical Center Christopher Kreulen, MD, MS 916-734-6805 [email protected]
Location Countries

United States

Verification Date

April 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: All study patients

Description: All study patients will be in one group.

Patient Data No
Study Design Info

Observational Model: Case-Control

Time Perspective: Prospective

Source: ClinicalTrials.gov