NCT03087396

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 148 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a post-market, multi-center, patient outcomes centered study to evaluate the on-label use of AccuFill during the Subchondroplasty procedure (SCP). Enrolled subjects will sign an informed consent form, satisfy the inclusion/exclusion criteria and have at least one bone marrow lesion, such as a cyst or stress fracture confirmed by diagnostic imaging in the foot and/or ankle joint. Demographics, medical history and medications will recorded at the time of enrollment. Surgical details including the SCP procedure, concomitant surgical procedures and intraoperative safety events will be recorded. Subjects will complete validated patient reported outcomes measures pre-operatively including the Foot Function Index (FFI) revised short form, the EQ-5D™ and numeric pain score. These measures plus a subject satisfaction survey will also be administered post-operatively at 6 weeks, 3 months, 6 months, 1 year, and 2 years. Screening for adverse events and revision surgeries will occur throughout the study. Target enrollment is 140 patients at up to 25 clinical sites. Subjects will complete the study at 2 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Treatment of insufficiency fractures	Filling of micro fractures or insufficiency fractures with a bone substitute material

Timeline

• Start date: 2017-03-10
• Primary completion: 2023-08-23
• Completion: 2023-08-23
• First posted: 2017-03-22
• Last updated: 2026-04-09
• Results posted: 2026-04-09

Locations

12 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study