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

Foot Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04338607
• Other study ID #: 1572490
• Status: Recruiting
• Start date: April 2, 2020
• Est. completion date: April 2, 2024

Study information

• Verified date: April 2020
• Source: MedShape, Inc
• Contact: Kenneth M Dupont, PhD, MS
• Phone: 6782353336
• Email: kenneth.dupont[@]medshape.com
• Is FDA regulated: No
• 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2, 2024
• Est. primary completion date: April 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Foot Arthritis

Intervention

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

Device:
• DynaNail Mini
Utilization of a novel sustained dynamic compression pseudoelastic intramedullary nail

Locations

Country	Name	City	State
United States	University of California, Davis Medical Center	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
MedShape, Inc	University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kreulen C, Lian E, Giza E. Technique for Use of Trabecular Metal Spacers in Tibiotalocalcaneal Arthrodesis With Large Bony Defects. Foot Ankle Int. 2017 Jan;38(1):96-106. doi: 10.1177/1071100716681743. Epub 2016 Dec 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fusion	Joint Fusion, as measured by radiograph and CT scan	From surgery up to one year post-surgery
Secondary	Pain - VAS	Pain Visual Analog Scale (VAS) - Rates the intensity of pain from 0 - 10 with 10 being the worst pain possible.	Pre-Operative up to one year post-surgery
Secondary	Veterans RAND 12 Item Health Survey (VR-12)	The Veterans RAND 12 Item Health Survey (VR-12, formerly called the Veterans SF-12) was Version Date 01.27.2020 3 developed from the Veterans RAND 36 (VR-36, formerly called the Veterans SF-36), which was modified from the original Medical Outcomes Survey (MOS) SF-36. The VR-12 measures Physical functioning (PF), social functioning (SF), role limitation due to physical problems (RP), role limitation due to emotional problems (RE), mental health (MH), energy and vitality (VT), bodily pain (BP) and general perception of health (GH). Standard based scoring (sometimes called norm based scoring) is used to calculate the physical component summary (PCS) and mental component summary (MCS) for both measures. The PCS and MCS are standardized using a t-score transformation and normed to a US population at a score of 50 and a standard deviation of 10.	Pre-Operative up to one year post-surgery
Secondary	Foot Function Index - Revised (FFI-R)	Measures the impact of foot pathology on function in terms of pain, disability, and activity restriction. The score is a percentage. The higher the score, the greater the disability.	Pre-Operative up to one year post-surgery
Secondary	Foot and Ankle Ability Measure (FAAM)	Measures activities of daily living and sports. The final score is a percentage. The higher final score represents a higher level of physical function.	Pre-Operative up to one year post-surgery
Secondary	American Orthopaedic Foot and Ankle Society Scales (AOFAS)	Clinician-based outcome that measures foot/ankle pain, function, and alignment. The lower the score, the greater the disability. The maximum score is 100.	Pre-Operative up to one year post-surgery