Patient Specific Talus Spacer Post Approval Study

Part of paid clinical trials in Santa Rosa, California.

Sponsor
Paragon 28
Study ID
NCT05364606
Status
Recruiting
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Conditions

  • Avascular Necrosis of the Talus

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Patient Specific Talus Spacer — DEVICE
    Patient Specific Talus Spacer is a solid polished replica of the patient's bone.

Study Details

Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study.

Key Dates

Start date
Jul 8, 2022
Status verified
Nov 2024
Primary completion
Aug 30, 2029
Completion
Nov 30, 2029

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: 50 Subjects
    50 Subjects Receiving the Patient Specific Talus Spacer.

Primary Outcome Measure

Clinically Significant Improvement in Pain on the Visual Analog Scale (VAS) [ Time Frame: At 5 years compared to Baseline ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Redwood OrthopaedicsSanta RosaCalifornia95403
Thomas Chang, DPM
707-544-3400
Thomas Chang, DMP (PRINCIPAL_INVESTIGATOR)
Fort Wayne OrthopedicsFort WayneIndiana46804
Faith Etherington, PA-C
260-436-8686
Matthew Beuchel, MD (PRINCIPAL_INVESTIGATOR)
Mercy Institute for Foot & Ankle ReconstructionBaltimoreMaryland21202
Maggie Manchester
[email protected]
Patrick Maloney, MD (PRINCIPAL_INVESTIGATOR)
Clifford Jeng, MD (SUB_INVESTIGATOR)
Lew Schon, MD (SUB_INVESTIGATOR)
Rebecca Cerrato, MD (SUB_INVESTIGATOR)
Duke Orthopeadics ArringdonMorrisvilleNorth Carolina27560
Kalynn Purnell
[email protected]
919-681-6035
Andrew Hanselman, MD (PRINCIPAL_INVESTIGATOR)
Mark Easley, MD (SUB_INVESTIGATOR)
Samuel Adams, MD (SUB_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
Josh Morningstar
[email protected]
Christoper Gross, MD (PRINCIPAL_INVESTIGATOR)
Daniel Scott, MD (SUB_INVESTIGATOR)
UT Physicians Orthopedics - PearlandPearlandTexas77584
Jordan Harmon
[email protected]
713-962-9954
Taggart Gauvain, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Santa Rosa, CA

By research site
Redwood Orthopaedics· Santa Rosa, CAFort Wayne Orthopedics· Fort Wayne, INMercy Institute for Foot & Ankle Reconstruction· Baltimore, MDDuke Orthopeadics Arringdon· Morrisville, NCMedical University of South Carolina· Charleston, SCUT Physicians Orthopedics - Pearland· Pearland, TX

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