Summary

for people ages 18 years and up (full criteria)
at Sacramento, California and other locations
study started
estimated completion
Eric Giza, MD

Description

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.

Details

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 Subjects will complete the study at 5 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.

Keywords

Insufficiency Fractures Stress Fracture Stress Fracture, Ankle, Foot and Toes bone marrow defect bone marrow lesion calcium phosphate bone substitute material Fractures, Bone Fractures, Stress Ankle Fractures Treatment of insufficiency fractures

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join if...

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

Locations

  • University of California, Davis accepting new patients
    Sacramento California 95817 United States
  • Stanford University Medical Center, Orthopedics accepting new patients
    Redwood City California 94063 United States

Lead Scientist

  • Eric Giza, MD
    Professor, Orthopaedic Surgery. Authored (or co-authored) 29 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Zimmer Biomet
Links
Sign up for this study
ID
NCT03087396
Study Type
Observational
Last Updated