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



Status:Recruiting
Conditions:Orthopedic, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:March 10, 2017
End Date:March 2024
Contact:Marianne D Rahme, BA
Email:marianne.rahme@zimmerbiomet.com
Phone:484-873-3343

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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.

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study at 5 years or will be withdrawn if the patient undergoes revision surgery of the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

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
We found this trial at
13
sites
6116 East Arbor Avenue
Mesa, Arizona 85206
Principal Investigator: Todd Haddon, DPM
Phone: 480-889-1211
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Bethlehem, Pennsylvania 18018
Principal Investigator: Brent Bernstein, DPM
Phone: 610-997-0408
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Bethlehem, PA
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Bryn Mawr, Pennsylvania 19010
Principal Investigator: David I Pedowitz, MD
Phone: 267-702-5159
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Bryn Mawr, PA
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4140 Jade Street
Capitola, California 95010
Principal Investigator: Nicholas Abidi, MD
Phone: 831-475-4024
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Capitola, CA
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Charlotte, North Carolina 28207
Principal Investigator: Robert B Anderson, MD
Phone: 704-323-2262
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Charlotte, NC
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12499 University Avenue
Clive, Iowa 50325
Principal Investigator: Michael S Lee, DPM
Phone: 515-440-2676
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Clive, IA
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491 John Young Way
Exton, Pennsylvania 19341
Principal Investigator: Jason R Miller, DPM
Phone: 610-280-1578
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Exton, PA
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Brian C Law, MD
Phone: 414-805-7386
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Rancho Mirage, California 92270
Principal Investigator: David A Friscia, MD
Phone: 760-766-2540
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Rancho Mirage, CA
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Redwood City, California 94063
Principal Investigator: Ariel Palanca, MD
Phone: 650-201-6317
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Redwood City, CA
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1 Shields Ave
Sacramento, California 95616
(530) 752-1011
Principal Investigator: Eric Giza, MD
Phone: 916-703-9191
University of California-Davis As we begin our second century, UC Davis is poised to become...
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10503 West Thunderbird Boulevard
Sun City, Arizona 85351
Principal Investigator: Jeffrey Holmes, DPM
Phone: 623-455-7142
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Sun City, AZ
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Vancouver, British Columbia
Principal Investigator: Alastair S Younger, MD
Phone: 604-806-8743
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