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, 2
years. At 3 years, 4 years, and 5 years, numeric pain scores and a patient satisfaction
survey will be collected. Screening for adverse events and revision surgeries will occur
throughout the study.

Target enrollment is 250 patients at up to 25 clinical sites. Subjects will complete the
study at 5 years or will be withdrawn if the patient undergoes revision surgery of the
Subchondroplasty site.

Inclusion Criteria:

- 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

Exclusion Criteria:

- Subject is pregnant at the time of surgery

- Subject is incarcerated

- Subject is involved in active litigation related to the condition being treated