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

Stress Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03087396
• Other study ID #: KC.CR.I.AM.16.2
• Status: Completed
• Start date: March 10, 2017
• Est. completion date: August 23, 2023

Study information

• Verified date: January 2024
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 Subjects will complete the study at 2 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: August 23, 2023
• Est. primary completion date: August 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Treatment of insufficiency fractures
Filling of micro fractures or insufficiency fractures with a bone substitute material

Locations

Country	Name	City	State
Canada	St. Paul's Hospital (Providence Health)	Vancouver	British Columbia
United States	Podiatry Center of the Lehigh Valley	Bethlehem	Pennsylvania
United States	Rothman Institute	Bryn Mawr	Pennsylvania
United States	OrthoNorcal	Capitola	California
United States	Capital Orthopaedics and Sports Medicine	Clive	Iowa
United States	Premier Orthopaedics & Sports Medicine	Exton	Pennsylvania
United States	OrthoArizona	Mesa	Arizona
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
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	The CORE Institute	Sun City	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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