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

Zimmer Biomet

Status: Completed

Conditions: Stress Fracture, Ankle, Foot and Toes; Insufficiency Fractures; Stress Fracture

Treatments: Device: Treatment of insufficiency fractures

Study type: Observational

Funder types: Industry

Identifiers

NCT03087396

KC.CR.I.AM.16.2

Details and patient eligibility

About

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.

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 Subjects will complete the study at 2 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.

Enrollment: 148 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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