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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

148 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-10

Study Completion Date

2023-08-23

Brief Summary

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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.

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Detailed Description

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 Subjects will complete the study at 2 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.

Conditions

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Insufficiency Fractures Stress Fracture Stress Fracture, Ankle, Foot and Toes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Treatment of insufficiency fractures

Filling of micro fractures or insufficiency fractures with a bone substitute material

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No