CompletedNot Applicable

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

United States148 participantsStarted 2017-03-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial 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

What they're measuring

Foot Function Index-Revised (FFI-R) Short Form Score at 24 Months

Timeframe: 24 months

Trial details

NCT IDNCT03087396

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-08-23

Results submitted2026-01-15

View on ClinicalTrials.gov More Insufficiency Fractures trials