NCT04338607

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2024

Completed
Last Updated

March 5, 2021

Status Verified

April 1, 2020

Enrollment Period

4 years

First QC Date

April 5, 2020

Last Update Submit

March 3, 2021

Conditions

Foot Arthritis

Keywords

Subtalar ArthrodesisIntramedullary NailSustained Dynamic Compression

Outcome Measures

Primary Outcomes (1)

  • Fusion

    Joint Fusion, as measured by radiograph and CT scan

    From surgery up to one year post-surgery

Secondary Outcomes (5)

  • 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

Study Arms (1)

All study patients

All study patients will be in one group.

Procedure: Subtalar (Talocalcaneal) arthrodesisDevice: DynaNail Mini

Interventions

Subtalar (Talocalcaneal) arthrodesisPROCEDURE

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

All study patients
DynaNail MiniDEVICE

Utilization of a novel sustained dynamic compression pseudoelastic intramedullary nail

All study patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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. Patients will be screened for eligibility by the research coordinator/ key personnel in close coordination with the surgeon. Patients at institute with end-stage talocalcaneal (subtalar) joint arthritis from any etiology will be eligible to enroll in the study. Frequently, subtalar arthritis is caused by trauma. Traumatic injuries have no predilection for race, religion, cultural background, etc. Therefore, all demographic groups will have access to this study and should be represented. Approximately 60 patients will be recruited for the study.

You may qualify if:

  • 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
  • years of age or older

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis Medical Center

Sacramento, California, 95816, United States

RECRUITING

Related 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.

    PMID: 27920334BACKGROUND

MeSH Terms

Interventions

Arthrodesis

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresSurgical Procedures, Operative

Study Officials

  • Christopher Kreulen, MD, MS

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth M Dupont, PhD, MS

CONTACT

6782353336kenneth.dupont@medshape.com

Chancey Sweeney, MPH, MHA

CONTACT

9167346017cassweeney@ucdavis.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2020

First Posted

April 8, 2020

Study Start

April 2, 2020

Primary Completion

April 2, 2024

Study Completion

April 2, 2024

Last Updated

March 5, 2021

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)