for people ages 18 years and up (full criteria)
at Sacramento, California and other locations
study started



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.

Official Title

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


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 Subjects will complete the study at 2 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.


Insufficiency Fractures, Stress Fracture, Stress Fracture, Ankle, Foot and Toes, bone marrow defect, bone marrow lesion, calcium phosphate, bone substitute material, Bone Fractures, Stress Fractures, Ankle Fractures, Treatment of insufficiency fractures


You can join if…

Open to people ages 18 years and up

  • Subject has at least one bone defect such as a bone marrow lesion (BML), cyst or stress fracture confirmed by diagnostic imaging
  • Surgeon considers the patient appropriate for the SCP procedure
  • Subject provides voluntary signature on the Institutional Review Board (IRB) approved Informed Consent
  • Subject is at least 18 years of age
  • Subject must be physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to complete outcome forms via the internet, telephone or regular mail

You CAN'T join if...

  • Subject is pregnant at the time of surgery
  • Subject is incarcerated
  • Subject is involved in active litigation related to the condition being treated


  • University of California, Davis
    Sacramento California 95817 United States
  • Stanford University Medical Center, Orthopedics
    Redwood City California 94063 United States


accepting new patients
Start Date
Completion Date
Zimmer Biomet
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Study Type
About 148 people participating
Last Updated