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Completed

NCT Number: NCT03087396

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

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.

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Key information

Conditions

Insufficiency Fractures Fractures, Bone Fractures, Stress Stress Fracture Stress Fracture, Ankle, Foot and Toes Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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 Subjects will complete the study at 2 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment of insufficiency fractures

Device

Filling of micro fractures or insufficiency fractures with a bone substitute material

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Mar 22, 2017
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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