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

Completed

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

In brief

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.

Key facts

Study ID

NCT03087396

Run by

Zimmer Biomet

People needed

148

Starts

2017-03-10

Expected to finish

2023-08-23

Last updated by the study team

2026-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

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

Where it is running

• OrthoArizona — Mesa, Arizona, United States
• The CORE Institute — Sun City, Arizona, United States
• OrthoNorcal — Capitola, California, United States
• Eisenhower Desert Orthopedic Center — Rancho Mirage, California, United States
• Stanford University Medical Center, Orthopedics — Redwood City, California, United States
• University of California, Davis — Sacramento, California, United States
• Capital Orthopaedics and Sports Medicine — Clive, Iowa, United States
• Podiatry Center of the Lehigh Valley — Bethlehem, Pennsylvania, United States
• Rothman Institute — Bryn Mawr, Pennsylvania, United States
• Premier Orthopaedics & Sports Medicine — Exton, Pennsylvania, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• St. Paul's Hospital (Providence Health) — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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