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

Completed

• Conditions: Insufficiency Fractures; Stress Fracture, Ankle, Foot and Toes; Stress Fracture

• Registration Number: NCT03087396
• Lead Sponsor: Zimmer Biomet

Brief 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.

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 Subjects will complete the study at 2 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.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

• Study First Submitted: 2017-02-21
• Study Start: 2017-03-10
• Study First Submitted QC: 2017-03-15
• Study First Posted: 2017-03-22
• Primary Completion: 2023-08-23
• Study Completion: 2023-08-23
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in EuroQol-5 Dimensions (EQ-5D) from baseline at 12 months	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.
Incidence and severity of device and/or procedure related adverse events and re-visions/re-operations	5 years	Summary and description of procedure and device related adverse events and surgical re-operations and relatedness to the bone substitute material and procedure
Change in numeric pain score from baseline at 12 Months	12 months	Change in numeric pain score using a 0-10 scale from baseline at 12 months.

Trial Locations

Locations (12)

OrthoArizona; 🇺🇸 Mesa,, Arizona, United States

The CORE Institute; 🇺🇸 Sun City, Arizona, United States

OrthoNorcal; 🇺🇸 Capitola, California, United States

Eisenhower Desert Orthopedic Center; 🇺🇸 Rancho Mirage, California, United States

Stanford University Medical Center, Orthopedics; 🇺🇸 Redwood City, California, United States

University of California, Davis; 🇺🇸 Sacramento, California, United States

Capital Orthopaedics and Sports Medicine; 🇺🇸 Clive, Iowa, United States

Podiatry Center of the Lehigh Valley; 🇺🇸 Bethlehem, Pennsylvania, United States

Rothman Institute; 🇺🇸 Bryn Mawr, Pennsylvania, United States

Premier Orthopaedics & Sports Medicine; 🇺🇸 Exton, Pennsylvania, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

St. Paul's Hospital (Providence Health); 🇨🇦 Vancouver, British Columbia, Canada