Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 Subjects will complete the study at 2 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment of insufficiency fractures | Device | Filling of micro fractures or insufficiency fractures with a bone substitute material |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks postoperative |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert B Anderson, MD | OrthoCarolina Research Institute, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OrthoArizona | Mesa | Arizona | 85206 | United States | ||
| The CORE Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Subchondroplasty With AccuFill® | Subjects with at least one bone marrow lesion (BML) of any of the bones of the foot and/or ankle, who have elected to undergo or who have undergone the Subchondroplasty procedure using AccuFill® bone substitute material. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 4, 2017 |
Not provided
Not provided
Not provided
Not provided
| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 2 year postoperative |
| Sun City |
| Arizona |
| 85351 |
| United States |
| OrthoNorcal | Capitola | California | 95010 | United States |
| Eisenhower Desert Orthopedic Center | Rancho Mirage | California | 92270 | United States |
| Stanford University Medical Center, Orthopedics | Redwood City | California | 94063 | United States |
| University of California, Davis | Sacramento | California | 95817 | United States |
| Capital Orthopaedics and Sports Medicine | Clive | Iowa | 50325 | United States |
| Podiatry Center of the Lehigh Valley | Bethlehem | Pennsylvania | 18018 | United States |
| Rothman Institute | Bryn Mawr | Pennsylvania | 19010 | United States |
| Premier Orthopaedics & Sports Medicine | Exton | Pennsylvania | 19341 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| St. Paul's Hospital (Providence Health) | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants had ≥1 bone marrow lesion (BML) in the foot/ankle and underwent the Subchondroplasty® procedure using AccuFill® bone substitute material. Per the Instructions For Use (IFU), AccuFill® was intended to be mixed with blood or saline; however, some participants received off-label treatment where other materials (e.g., platelet rich plasma or bone marrow aspirate concentrate) were used. All participants are reported together for baseline measures.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Subchondroplasty With AccuFill® | Subjects with at least one bone marrow lesion (BML) of any of the bones of the foot and/or ankle, who have elected to undergo or who have undergone the Subchondroplasty procedure using AccuFill® bone substitute material. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Pain and functional performance at baseline by the Foot Function Index | 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. | Of 148 enrolled participants, 134 were analyzed for most measures. For the activity limitation domain, N=133 due to missing data for one participant. Fourteen participants were not analyzed overall because data were unavailable or they discontinued early; specific reasons were not documented. | Mean | Standard Deviation | Percentage scale |
| |||||||||||||||
| Pain and functional performance at baseline by the Numeric Pain Scale (NPS) | NPS score reported on a 0-10 scale, where 0 indicates no pain and 10 indicates worst possible pain. Higher scores reflect greater pain intensity. | Mean | Standard Deviation | Points on a scale (0-10) |
| ||||||||||||||||
| Foot Function Index at Baseline | 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 and does not indicate worse function. Subscales calculated from applicable items and converted to 0-100%. Higher=more pain/worse function. | Of 148 enrolled participants, 134 were analyzed. Fourteen participants were not analyzed overall because data were unavailable or they discontinued early; specific reasons were not documented. | Mean | Standard Deviation | Percentage scale |
| |||||||||||||||
| Subject quality-of-life at baseline by the EQ-5D-5L | Mean | Standard Deviation | Index score (0-1) |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 24 months, N=98 reflects participants with available outcome data at that visit. | Posted | Mean | Standard Deviation | Percentage scale | 24 months |
|
|
| |||||||||||||||||||||||||||
| Secondary | 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. | All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 6 weeks, N=136 reflects participants with available outcome data at that visit. | Posted | Mean | Standard Deviation | Points on scale | 6 weeks postoperative |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 6 weeks, N=134 reflects participants with available outcome data at that visit. | Posted | Mean | Standard Deviation | Percentage scale | 6 weeks postoperative |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 3 months, N=125 reflects participants with available outcome data at that visit. | Posted | Mean | Standard Deviation | Percentage scale | 3 Months postoperative |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 6 months, N=118 reflects participants with available outcome data at that visit. | Posted | Mean | Standard Deviation | Percentage scale | 6 Months postoperative |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 1 year, N=114 reflects participants with available outcome data at that visit. | Posted | Mean | Standard Deviation | Percentage scale | 1 Year postoperative |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 12-weeks, N=136 reflects participants with available outcome data at that visit. | Posted | Mean | Standard Deviation | Points on scale | 12 weeks postoperative |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 3 months, N=125 reflects participants with available outcome data at that visit. | Posted | Mean | Standard Deviation | Points on scale | 3 months postoperative |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 6 months, N=118 reflects participants with available outcome data at that visit. | Posted | Mean | Standard Deviation | Points on scale | 6 months postoperative |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 1 year, N=113reflects participants with available outcome data at that visit. | Posted | Mean | Standard Deviation | Points on scale | 1 year postoperative |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 2 years, N=99 reflects participants with available outcome data at that visit. | Posted | Mean | Standard Deviation | Points on scale | 2 years postoperative |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 6-weeks, N=137 reflects participants with available outcome data at that visit. | Posted | Mean | Standard Deviation | Index score | 6 weeks postoperative |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 3 months, N=126 reflects participants with available outcome data at that visit. | Posted | Mean | Standard Deviation | Index score | 3 months postoperative |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 6 months, N=119 reflects participants with available outcome data at that visit. | Posted | Mean | Standard Deviation | Index score | 6 months postoperative |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 1 year, N=114 reflects participants with available outcome data at that visit. | Posted | Mean | Standard Deviation | Index score | 1 year postoperative |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 2 years, N=99 reflects participants with available outcome data at that visit. | Posted | Mean | Standard Deviation | Index score | 2 year postoperative |
|
|
Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subchondroplasty With AccuFill® (On-Label) | Subjects with at least one bone marrow lesion (BML) of any of the bones of the foot and/or ankle, who have elected to undergo or who have undergone the Subchondroplasty procedure using AccuFill® bone substitute material. | 1 | 142 | 24 | 142 | 44 | 142 |
| EG001 | Subchondroplasty With AccuFill® (Off-Label) | Participants had ≥1 bone marrow lesion (BML) in the foot/ankle and underwent the Subchondroplasty® procedure using AccuFill® bone substitute material. Per the Instructions For Use (IFU), AccuFill® was intended to be mixed with blood or saline; however, some participants received off-label treatment where other materials (e.g., platelet rich plasma or bone marrow aspirate concentrate) were used. | 0 | 6 | 1 | 6 | 3 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain similar to pre-existing level with ambulation | Musculoskeletal and connective tissue disorders | Systematic Assessment | Continued to describe pain similar to pre-existing level with ambulation. Provided intraarticular steroid injection without relief, MRI found medial and lateral talar dome lesion |
| |
| Contracture of fifth toe, TTP and spasming of the extensor tendon | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Degenerative disc | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Exacerbation of lymphedema of right leg | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Fibroid Uterus causing abnormal uterine bleeding | Reproductive system and breast disorders | Systematic Assessment | Symptoms include pelvic and back pain. Confirmed with imaging. |
| |
| Fibrous coalition | Musculoskeletal and connective tissue disorders | Systematic Assessment | Worsened with a midfoot sprain SCP was used to try stabilized the bone marrow lesion of the cuboid. |
| |
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Intractable subacute left foot postoperative pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Iron deficiency, anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Left ankle nerve pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | With numbing, burning, tingling sensations; cramping and cold toes |
| |
| Left foot and ankle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | With point tenderness overlying plantar fibroma |
| |
| Left talus bony edema | Injury, poisoning and procedural complications | Systematic Assessment | Identified via MRI post subject fall |
| |
| Medial foot pain (Left) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Morton's neuroma | Musculoskeletal and connective tissue disorders | Systematic Assessment | Between second and third metatarsals of right foot |
| |
| Numbness left lateral hindfoot | Musculoskeletal and connective tissue disorders | Systematic Assessment | At peroneal tendon/calcaneal osteotomy site |
| |
| Ongoing pain from multiple pre-existing injuries | Musculoskeletal and connective tissue disorders | Systematic Assessment | Left knee, left foot, both ankles. Original SCP procedure to treat aforementioned injuries. Also had pre-existing painful hardware. |
| |
| Chest pain radiating to left arm | Cardiac disorders | Systematic Assessment | History of CHF and has been maintained on high dose Carvedilol at 25mg BID but ran out of Carvedilol |
| |
| Chronic left ankle stability (reported term) | Musculoskeletal and connective tissue disorders | Systematic Assessment | Event likely refers to chronic left ankle instability, a condition characterized by recurrent giving way of the ankle joint. Reported as an adverse event following the procedure. |
| |
| Postmenopausal bleeding | Reproductive system and breast disorders | Systematic Assessment | Diagnostic tests show endometrial polyps, removed surgically. |
| |
| Continued osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Early arthritis in the right ankle had undergone original SCP procedure in 2019 to help slow progression but remains symptomatic |
| |
| Plantar fasciitis and Achilles tendon pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Right Ankle Instability and 2nd Hammertoe | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Right ankle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| L 2nd/5th metatarsal fractures | Musculoskeletal and connective tissue disorders | Systematic Assessment | Subject was non-compliant with weight-bearing restrictions, walked on a golf course in flip-flops, and experienced a "snap." Subsequent imaging confirmed fractures of the left 2nd and 5th metatarsals. |
| |
| Stress Fracture (or Stress Response of Metatarsal) | Injury, poisoning and procedural complications | Systematic Assessment | Patient diagnosed with stress response in surgical metatarsal via MRI. Did not respond to conservative treatment (bone stimulator, immobilization). Source description truncated; no further details available. |
| |
| Exacerbation of lymphedema of right leg | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Severe postop pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Right ankle |
| |
| Increased right medial ankle/midfoot pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | with swelling and bruising (hematoma) |
| |
| Right ankle pain for months/years | Musculoskeletal and connective tissue disorders | Systematic Assessment | Developed more pain and impingement after contralateral side healed from surgery |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ankle instability | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Sinus tarsi syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Increase in VAS pain score | Musculoskeletal and connective tissue disorders | Systematic Assessment | Expected increase in VAS pain score from preop vs. 2-week postop period |
| |
| Increased numeric pain score postop | Musculoskeletal and connective tissue disorders | Systematic Assessment | From 1/10 at 1-year follow-up to 5/10 at 2-year follow-up, likely due to increase in activity and requiring proper shoes and orthotics |
| |
| Increased numeric pain score postop | Musculoskeletal and connective tissue disorders | Systematic Assessment | Increased from 3/10 to 5/10 at 1-year follow up; patient had instability and ankle osteoarthritis at the time of surgery |
| |
| Increased VAS pain score due to increased activity | Musculoskeletal and connective tissue disorders | Systematic Assessment | 1/10 preop, 3/10 at 2 weeks postop, 4/10 at 6 weeks postop, then 3/10 3-months postop, and finally 4/10 at 6-months postop |
| |
| Increased VAS pain score | Musculoskeletal and connective tissue disorders | Systematic Assessment | 5/10 at preop to 8/10 at 2 weeks, then 6/10 at 6 weeks, and finally to 6/10 at 3 months |
| |
| Pain score increased from baseline to 2 weeks | Musculoskeletal and connective tissue disorders | Systematic Assessment | Consistent with normal postop course. Pain scale went down by 6 week follow up but patient lost to follow up. |
| |
| Patient numeric pain scale increased intensity with resolution | Musculoskeletal and connective tissue disorders | Systematic Assessment | Increased from preop to 2 weeks postop and from 6 weeks to 3 months. Pain fully resolved now. |
| |
| Increased pain scale postop with subsequent improvement | Musculoskeletal and connective tissue disorders | Systematic Assessment | Pain scale increased from preop score to 2 weeks and from 6 weeks to 3 months. Pain steadily decreased from 6 months to 1 year. |
| |
| Post traumatic arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Tendinitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| No resolution in pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Decreased edema confirmed on MRI |
| |
| Suspected Morton's neuroma | Musculoskeletal and connective tissue disorders | Systematic Assessment | Patient reported increased discomfort to the top of the left foot; traeted with steroid injection |
| |
| Morton's Neuroma, right | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Expected routine postoperative pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Pain in patient with low pain tolerance |
| |
| Posterolateral ankle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| First MTP pain with increased activity | Musculoskeletal and connective tissue disorders | Systematic Assessment | Minimal pain at SCP site |
| |
| Further ankle surgery (right) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Small spur on the lateral foot causing shoe gear irritation | Musculoskeletal and connective tissue disorders | Systematic Assessment | Surgical excision of bone spur completed |
| |
| Pain and inflammation of surgically treated foot | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| MCJ Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| New fracture in the cuboid bone (operative foot) | Musculoskeletal and connective tissue disorders | Systematic Assessment | Patient wearing boot again |
| |
| Peroneal tendon repair surgery (left foot) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Cortical perforation during cannula placement | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pain score at 3 month is higher than baseline | Musculoskeletal and connective tissue disorders | Systematic Assessment | Patient underwent a further procedure which likely led to pain increase score during recovery |
| |
| Sinus tarsi inflammation (Left foot) | Musculoskeletal and connective tissue disorders | Systematic Assessment | Non-study site implant area, caused by increased PT for her knee |
| |
| Small abscess/cellulitis on upper left calf due | Musculoskeletal and connective tissue disorders | Systematic Assessment | Patient reported occasional skin infections |
| |
| Worsening of pain and decreased mobility | Musculoskeletal and connective tissue disorders | Systematic Assessment | With moderate swelling, increased pronation, and deformity. Medial and lateral tenderness to palpitation, worsening of Left hindfoot valgus, posterion tibial tendon dysfunction worsened |
| |
| Nocturnal seizure | Psychiatric disorders | Systematic Assessment | History of chronic seizures; recent seizure caused significant pain in his right shoulder |
| |
| X-ray finding of minimal extravasation...of the right ankle | Musculoskeletal and connective tissue disorders | Systematic Assessment | Minimal swelling at 2 week follow up |
| |
| Increased pain in foot/ankle after ambulation | Musculoskeletal and connective tissue disorders | Systematic Assessment | Patient walked without brace resulting in increased pain. Also discontinued gabapentin due to beginning a new pain medication. |
| |
| Pain overlying left cuboid | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Left tarsal tunnel syndrome with bone marrow edema | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Severe erythema of left ankle (non-study) site incision | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Wound dehiscence with drainage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Bursitis (right ankle) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Attenuation/scarring of posterior right tibial tendon | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain (Left Ankle) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Right medial ankle erythema | Injury, poisoning and procedural complications | Systematic Assessment | Right ankle incision macerated with 2 areas of dehiscence |
| |
| 1 inch superficial non healing wound | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| increased pain at the metatarsal ORIF surgical site | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment | Patient fell on surgery foot |
| |
| Increased pain and swelling (Left ankle) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Right ankle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annette Tieu, Clinical Research Specialist | Zimmer Biomet | 971-482-9622 | annette.tieu@zimmerbiomet.com |
| Oct 22, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015775 | Fractures, Stress |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
Not provided
Not provided
|
| Unknown or Not Reported |
|
|
|
| White |
|
|
| Other |
|
|
| Decline to Respond |
|
|
| Asian |
|
|
| Unknown or Not Reported |
|
|
|
| Stiffness |
|
|
| Difficulty |
|
|
| Activity Limitation |
|
|
| Social Issues |
|
|
|
| Off-Label |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|