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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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
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

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

Other trials in United States

Canada1 site

  • St. Paul's Hospital (Providence Health)

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

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.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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.

  1. First posted22 Mar 2017
  2. Study start10 Mar 2017
  3. Primary completion23 Aug 2023
  4. Study completion23 Aug 2023

Resources

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)
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
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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