Insufficiency Fractures, Stress Fracture, Stress Fracture, Ankle, Foot and Toes
Conditions
Keywords
bone marrow defect, bone marrow lesion, stress fracture, calcium phosphate, bone substitute material
Brief 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. 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 Subjects will complete the study at 2 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.
Interventions
DEVICETreatment of insufficiency fractures
Filling of micro fractures or insufficiency fractures with a bone substitute material
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Foot Function Index-Revised (FFI-R) Short Form Score at 24 Months | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain and Functional Performance by the Numeric Pain Score (NPS) From Baseline at 6-weeks | 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. |
| Pain and Functional Performance at 6 Weeks by the Foot Function Index-Revised (FFI-R) Short Form | 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. |
| Pain and Functional Performance at 3 Months by the Foot Function Index-Revised (FFI-R) Short Form | 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. |
| Pain and Functional Performance at 6 Months by the Foot Function Index-Revised (FFI-R) Short Form | 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. |
| Pain and Functional Performance at 1 Year by the Foot Function Index-Revised (FFI-R) Short Form | 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. |
| Pain and Functional Performance at 12-weeks by the Numeric Pain Score (NPS) | 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. |
| Pain and Functional Performance at 3-months by the Numeric Pain Score (NPS) | 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. |
| Pain and Functional Performance at 6-months by the Numeric Pain Score (NPS) | 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. |
| Pain and Functional Performance at 1-year by the Numeric Pain Score (NPS) | 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. |
| Pain and Functional Performance at 2-years by the Numeric Pain Score (NPS) | 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. |
| Subject Quality-of-life at 6-weeks by the EQ-5D | 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. |
| Subject Quality-of-life at 3-months by the EQ-5D | 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. |
| Subject Quality-of-life at 6-months by the EQ-5D | 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. |
| Subject Quality-of-life at 1-year by the EQ-5D | 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. |
| Subject Quality-of-life at 2-years by the EQ-5D | 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. |
Countries
Canada, United States
Contacts
PRINCIPAL_INVESTIGATORRobert B Anderson, MD
OrthoCarolina Research Institute, Inc.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 45.27 years STANDARD_DEVIATION 12.61 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 120 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Foot Function Index at Baseline | 62.5 Percentage scale STANDARD_DEVIATION 16.6 |
| Pain and functional performance at baseline by the Foot Function Index Activity Limitation | 65.4 Percentage scale STANDARD_DEVIATION 20.2 |
| Pain and functional performance at baseline by the Foot Function Index Difficulty | 69.9 Percentage scale STANDARD_DEVIATION 17.9 |
| Pain and functional performance at baseline by the Foot Function Index Pain | 65.7 Percentage scale STANDARD_DEVIATION 18.2 |
| Pain and functional performance at baseline by the Foot Function Index Social Issues | 50.9 Percentage scale STANDARD_DEVIATION 20.6 |
| Pain and functional performance at baseline by the Foot Function Index Stiffness | 61.0 Percentage scale STANDARD_DEVIATION 21.4 |
| Pain and functional performance at baseline by the Numeric Pain Scale (NPS) | 5.2 Points on a scale (0-10) STANDARD_DEVIATION 2.3 |
| Race/Ethnicity, Customized Asian | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants |
| Race/Ethnicity, Customized Decline to Respond | 5 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Other | 5 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 3 Participants |
| Race/Ethnicity, Customized White | 125 Participants |
| Region of Enrollment Canada | 7 participants |
| Region of Enrollment United States | 141 participants |
| Sex: Female, Male Female | 85 Participants |
| Sex: Female, Male Male | 63 Participants |
| Subject quality-of-life at baseline by the EQ-5D-5L | 0.5 Index score (0-1) STANDARD_DEVIATION 0.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 142 | 0 / 6 |
| other Total, other adverse events | 44 / 142 | 3 / 6 |
| serious Total, serious adverse events | 24 / 142 | 1 / 6 |
Outcome results
None listed