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

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.

Study Overview

• Status: Completed
• Conditions: Stress Fracture; Insufficiency Fractures; Stress Fracture, Ankle, Foot and Toes
• Intervention / Treatment: Device: Treatment of insufficiency fractures

Detailed Description

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 Subjects will complete the study at 2 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.

• Study Type: Observational
• Enrollment (Actual): 148

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St. Paul's Hospital (Providence Health)
• United States
  • Arizona
    • Mesa, Arizona, United States, 85206
      • OrthoArizona
    • Sun City, Arizona, United States, 85351
      • The Core Institute
  • California
    • Capitola, California, United States, 95010
      • OrthoNorcal
    • Rancho Mirage, California, United States, 92270
      • Eisenhower Desert Orthopedic Center
    • Redwood City, California, United States, 94063
      • Stanford University Medical Center, Orthopedics
    • Sacramento, California, United States, 95817
      • University of California, Davis
  • Iowa
    • Clive, Iowa, United States, 50325
      • Capital Orthopaedics and Sports Medicine
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18018
      • Podiatry Center of the Lehigh Valley
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Rothman Institute
    • Exton, Pennsylvania, United States, 19341
      • Premier Orthopaedics & Sports Medicine
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Approximately 140 subjects, each with at least one bone marrow lesion (BML) in any of the bones of the foot and/or ankle who have elected to undergo or have undergone the Subchondroplasty (SCP) procedure will be enrolled in the study.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Foot Function Index-Revised (FFI-R) short form score at 12 Months	Change from baseline score, range 0-100, for patient reported pain, stiffness, difficulty, activity limitation and social issues at 12 months.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of device and/or procedure related adverse events and re-visions/re-operations	Summary and description of procedure and device related adverse events and surgical re-operations and relatedness to the bone substitute material and procedure	5 years
Change in numeric pain score from baseline at 12 Months	Change in numeric pain score using a 0-10 scale from baseline at 12 months.	12 months
Change in EuroQol-5 Dimensions (EQ-5D) from baseline at 12 months	Change in patient quality of life from baseline at 12 months. A scoring function is created using a population preference weighted health index. The change from the baseline score will be measured at 12 months.	12 months

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Principal Investigator: Robert B Anderson, MD, OrthoCarolina Research Institute, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2017
• Primary Completion (Actual): August 23, 2023
• Study Completion (Actual): August 23, 2023

Study Registration Dates

• First Submitted: February 21, 2017
• First Submitted That Met QC Criteria: March 15, 2017
• First Posted (Actual): March 22, 2017

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: calcium phosphate; bone marrow defect; bone marrow lesion; stress fracture; bone substitute material
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries; Fractures, Bone; Fractures, Stress; Ankle Fractures
• Other Study ID Numbers: KC.CR.I.AM.16.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No