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.
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 Subjects will complete the study at 2 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.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
OBSERVATIONAL
Enrollment
148
Filling of micro fractures or insufficiency fractures with a bone substitute material
OrthoArizona
Mesa, Arizona, United States
The CORE Institute
Sun City, Arizona, United States
OrthoNorcal
Capitola, California, United States
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.
Time frame: 24 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 3 Months postoperative
Pain and Functional Performance at 6 Months by the Foot Function Index-Revised (FFI-R) Short Form
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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
Capital Orthopaedics and Sports Medicine
Clive, Iowa, United States
Podiatry Center of the Lehigh Valley
Bethlehem, Pennsylvania, United States
Rothman Institute
Bryn Mawr, Pennsylvania, United States
Premier Orthopaedics & Sports Medicine
Exton, Pennsylvania, United States
...and 2 more locations
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 year postoperative