MedTrace Logo

A Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Foot/Ankle

NCT03087396 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 148

Last updated 2026-04-09

Study results available
· View outcomes & findings →

Summary

Post Market clinical outcomes study to collect data on the short - and long-term outcomes for subjects who are undergoing or who have undergone the Subchondroplasty Procedure in the foot and/or ankle in a standard clinical setting. Outcomes to be assessed include pain medication usage, pain, function, activity levels and patient satisfaction.

Conditions

  • Insufficiency Fractures
  • Stress Fracture
  • Stress Fracture, Ankle, Foot and Toes

Interventions

DEVICE

Treatment of insufficiency fractures

Filling of micro fractures or insufficiency fractures with a bone substitute material

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Robert B Anderson, MD · OrthoCarolina Research Institute, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-10
Primary Completion
2023-08-23
Completion
2023-08-23
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03087396 on ClinicalTrials.gov