Insufficiency FracturesNCT03087396
A Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Foot/Ankle
An observational study of Insufficiency Fractures and Stress Fracture, run by Zimmer Biomet at 12 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insufficiency Fractures, Stress Fracture, Stress Fracture, Ankle, Foot and Toes
- What is being tested?
- Treatment of insufficiency fractures
- Type of treatment
- Medical device
- How many people
- 148 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 10 Mar 2017to 23 Aug 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Subject is pregnant at the time of surgery
- Subject is incarcerated
- Subject is involved in active litigation related to the condition being treated
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
Podiatry Center of the Lehigh Valley
Bethlehem, Pennsylvania, 18018
Rothman Institute
Bryn Mawr, Pennsylvania, 19010
OrthoNorcal
Capitola, California, 95010
Capital Orthopaedics and Sports Medicine
Clive, Iowa, 50325
Premier Orthopaedics & Sports Medicine
Exton, Pennsylvania, 19341
OrthoArizona
Mesa, Arizona, 85206
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Eisenhower Desert Orthopedic Center
Rancho Mirage, California, 92270
Stanford University Medical Center, Orthopedics
Redwood City, California, 94063
University of California, Davis
Sacramento, California, 95817
The CORE Institute
Sun City, Arizona, 85351
Canada1 site
St. Paul's Hospital (Providence Health)
Vancouver, British Columbia, V6Z 1Y6
About this study
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.
Read the 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.
- Being tested
- Treatment of insufficiency fractures
- Keywords
- bone marrow defect, bone marrow lesion, stress fracture, calcium phosphate, bone substitute material
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of insufficiency fracturesDevice
Filling of micro fractures or insufficiency fractures with a bone substitute material
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot Function Index-Revised (FFI-R) Short Form Score at 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.
Measured: 24 months
Secondary outcomes (15)
Pain and Functional Performance by the Numeric Pain Score (NPS) From Baseline at 6-weeks
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.
Measured: 6 weeks postoperative
Pain and Functional Performance at 6 Weeks by the Foot Function Index-Revised (FFI-R) Short Form
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.
Measured: 6 weeks postoperative
Pain and Functional Performance at 3 Months by the Foot Function Index-Revised (FFI-R) Short Form
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.
Measured: 3 Months postoperative
Pain and Functional Performance at 6 Months by the Foot Function Index-Revised (FFI-R) Short Form
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.
Measured: 6 Months postoperative
Pain and Functional Performance at 1 Year by the Foot Function Index-Revised (FFI-R) Short Form
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.
Measured: 1 Year postoperative
Pain and Functional Performance at 12-weeks by the Numeric Pain Score (NPS)
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.
Measured: 12 weeks postoperative
Pain and Functional Performance at 3-months by the Numeric Pain Score (NPS)
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.
Measured: 3 months postoperative
Pain and Functional Performance at 6-months by the Numeric Pain Score (NPS)
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.
Measured: 6 months postoperative
Pain and Functional Performance at 1-year by the Numeric Pain Score (NPS)
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.
Measured: 1 year postoperative
Pain and Functional Performance at 2-years by the Numeric Pain Score (NPS)
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.
Measured: 2 years postoperative
Subject Quality-of-life at 6-weeks by the EQ-5D
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.
Measured: 6 weeks postoperative
Subject Quality-of-life at 3-months by the EQ-5D
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.
Measured: 3 months postoperative
Subject Quality-of-life at 6-months by the EQ-5D
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.
Measured: 6 months postoperative
Subject Quality-of-life at 1-year by the EQ-5D
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.
Measured: 1 year postoperative
Subject Quality-of-life at 2-years by the EQ-5D
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.
Measured: 2 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start10 Mar 2017
- Primary completion23 Aug 2023
- Study completion23 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Insufficiency FracturesStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert B Anderson, MD, Principal investigator, OrthoCarolina Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087396
- Sponsor's protocol ID
- KC.CR.I.AM.16.2
- Status last verified
- Jan 2024
- First submitted
- 21 Feb 2017
- Last updated
- 9 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Foot/Ankle
- ClinicalTrials.gov ID
- NCT03087396
- Acronym / sponsor ID
- KC.CR.I.AM.16.2
- Keywords
- bone marrow defect, bone marrow lesion, stress fracture, calcium phosphate, bone substitute material
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 23 Aug 2023 (actual)
- First posted
- 22 Mar 2017 (actual)
- Results
- Posted 9 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Subject is pregnant at the time of surgery
- Subject is incarcerated
- Subject is involved in active litigation related to the condition being treated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment of insufficiency fracturesFilling of micro fractures or insufficiency fractures with a bone substitute material | Device | – |
Primary outcome
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.
15 secondary outcomes
Pain and Functional Performance by the Numeric Pain Score (NPS) From Baseline at 6-weeks
Time frame: 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
Pain and Functional Performance at 3 Months by the Foot Function Index-Revised (FFI-R) Short Form
Time frame: 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
Pain and Functional Performance at 1 Year by the Foot Function Index-Revised (FFI-R) Short Form
Time frame: 1 Year postoperative
Pain and Functional Performance at 12-weeks by the Numeric Pain Score (NPS)
Time frame: 12 weeks postoperative
Pain and Functional Performance at 3-months by the Numeric Pain Score (NPS)
Time frame: 3 months postoperative
Pain and Functional Performance at 6-months by the Numeric Pain Score (NPS)
Time frame: 6 months postoperative
Pain and Functional Performance at 1-year by the Numeric Pain Score (NPS)
Time frame: 1 year postoperative
Pain and Functional Performance at 2-years by the Numeric Pain Score (NPS)
Time frame: 2 years postoperative
Subject Quality-of-life at 6-weeks by the EQ-5D
Time frame: 6 weeks postoperative
Subject Quality-of-life at 3-months by the EQ-5D
Time frame: 3 months postoperative
Subject Quality-of-life at 6-months by the EQ-5D
Time frame: 6 months postoperative
Subject Quality-of-life at 1-year by the EQ-5D
Time frame: 1 year postoperative
Subject Quality-of-life at 2-years by the EQ-5D
Time frame: 2 year postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert B Anderson, MD principal investigator
OrthoCarolina Research Institute, Inc.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insufficiency Fractures and Stress Fracture, run by Zimmer Biomet at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot Function Index-Revised (FFI-R) Short Form Score at 24 Months (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.