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

March 30, 2026 updated by: Zimmer Biomet
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Subjects will complete the study at 2 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
148

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Foot Function Index-Revised (FFI-R) Short Form Score at 24 Months
Time Frame: 24 months
Foot Function Index - Revised Short Form (FFI-R SF) subscale scores. Measures foot pain, disability, and activity limitation. Items scored 1-4 (1=best, 4=worst); 5=not applicable to the subject and does not indicate worse function. Subscales calculated from applicable items and converted to 0-100%. Higher=more pain/worse function.
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain and Functional Performance by the Numeric Pain Score (NPS) From Baseline at 6-weeks
Time Frame: 6 weeks postoperative
Numeric Pain Score (NPS) reported on a 0-10 scale, where 0 = no pain and 10 = worst possible pain. Higher scores indicate greater pain intensity. Baseline values reflect pre-operative pain levels.
6 weeks postoperative
Pain and Functional Performance at 6 Weeks by the Foot Function Index-Revised (FFI-R) Short Form
Time Frame: 6 weeks postoperative
Foot Function Index - Revised Short Form (FFI-R SF) subscale scores. Measures foot pain, disability, and activity limitation. Items scored 1-4 (1=best, 4=worst); 5=not applicable to the subject and does not indicate worse function. Subscales calculated from applicable items and converted to 0-100%. Higher=more pain/worse function.
6 weeks postoperative
Pain and Functional Performance at 3 Months by the Foot Function Index-Revised (FFI-R) Short Form
Time Frame: 3 Months postoperative
Foot Function Index - Revised Short Form (FFI-R SF) subscale scores. Measures foot pain, disability, and activity limitation. Items scored 1-4 (1=best, 4=worst); 5=not applicable to the subject and does not indicate worse function. Subscales calculated from applicable items and converted to 0-100%. Higher=more pain/worse function.
3 Months postoperative
Pain and Functional Performance at 6 Months by the Foot Function Index-Revised (FFI-R) Short Form
Time Frame: 6 Months postoperative
Foot Function Index - Revised Short Form (FFI-R SF) subscale scores. Measures foot pain, disability, and activity limitation. Items scored 1-4 (1=best, 4=worst); 5=not applicable to the subject and does not indicate worse function. Subscales calculated from applicable items and converted to 0-100%. Higher=more pain/worse function.
6 Months postoperative
Pain and Functional Performance at 1 Year by the Foot Function Index-Revised (FFI-R) Short Form
Time Frame: 1 Year postoperative
Foot Function Index - Revised Short Form (FFI-R SF) subscale scores. Measures foot pain, disability, and activity limitation. Items scored 1-4 (1=best, 4=worst); 5=not applicable to the subject and does not indicate worse function. Subscales calculated from applicable items and converted to 0-100%. Higher=more pain/worse function.
1 Year postoperative
Pain and Functional Performance at 12-weeks by the Numeric Pain Score (NPS)
Time Frame: 12 weeks postoperative
Numeric Pain Score (NPS) reported on a 0-10 scale, where 0 = no pain and 10 = worst possible pain. Higher scores indicate greater pain intensity. Baseline values reflect pre-operative pain levels.
12 weeks postoperative
Pain and Functional Performance at 3-months by the Numeric Pain Score (NPS)
Time Frame: 3 months postoperative
Numeric Pain Score (NPS) reported on a 0-10 scale, where 0 = no pain and 10 = worst possible pain. Higher scores indicate greater pain intensity. Baseline values reflect pre-operative pain levels.
3 months postoperative
Pain and Functional Performance at 6-months by the Numeric Pain Score (NPS)
Time Frame: 6 months postoperative
Numeric Pain Score (NPS) reported on a 0-10 scale, where 0 = no pain and 10 = worst possible pain. Higher scores indicate greater pain intensity. Baseline values reflect pre-operative pain levels.
6 months postoperative
Pain and Functional Performance at 1-year by the Numeric Pain Score (NPS)
Time Frame: 1 year postoperative
Numeric Pain Score (NPS) reported on a 0-10 scale, where 0 = no pain and 10 = worst possible pain. Higher scores indicate greater pain intensity. Baseline values reflect pre-operative pain levels.
1 year postoperative
Pain and Functional Performance at 2-years by the Numeric Pain Score (NPS)
Time Frame: 2 years postoperative
Numeric Pain Score (NPS) reported on a 0-10 scale, where 0 = no pain and 10 = worst possible pain. Higher scores indicate greater pain intensity. Baseline values reflect pre-operative pain levels.
2 years postoperative
Subject Quality-of-life at 6-weeks by the EQ-5D
Time Frame: 6 weeks postoperative
Assesses health-related quality of life across five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Scores typically range from -0.594 to 1.000, where 1.000 indicates perfect health and lower scores indicate poorer health status.
6 weeks postoperative
Subject Quality-of-life at 3-months by the EQ-5D
Time Frame: 3 months postoperative
Assesses health-related quality of life across five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Scores typically range from -0.594 to 1.000, where 1.000 indicates perfect health and lower scores indicate poorer health status.
3 months postoperative
Subject Quality-of-life at 6-months by the EQ-5D
Time Frame: 6 months postoperative
Assesses health-related quality of life across five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Scores typically range from -0.594 to 1.000, where 1.000 indicates perfect health and lower scores indicate poorer health status.
6 months postoperative
Subject Quality-of-life at 1-year by the EQ-5D
Time Frame: 1 year postoperative
Assesses health-related quality of life across five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Scores typically range from -0.594 to 1.000, where 1.000 indicates perfect health and lower scores indicate poorer health status.
1 year postoperative
Subject Quality-of-life at 2-years by the EQ-5D
Time Frame: 2 year postoperative
Assesses health-related quality of life across five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Scores typically range from -0.594 to 1.000, where 1.000 indicates perfect health and lower scores indicate poorer health status.
2 year postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zimmer Biomet

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert B Anderson, MD, OrthoCarolina Research Institute, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 23, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 23, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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