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| Name | Class |
|---|---|
| MedNet Solutions | UNKNOWN |
| Medical Metrics Diagnostics, Inc | INDUSTRY |
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This is a multi-center, prospective, single-blinded, two-arm study, randomized to include approximately 134 subjects treated with Subchondroplasty (SCP) + Arthroscopy and 67 subjects with arthroscopy alone.
The primary objective of this study is to demonstrate superiority of Subchondroplasty with arthroscopy compared to arthroscopy alone for treatment of Bone Marrow Lesions (BMLs) in the knee.
This is a multicenter, prospective, single-blinded, two-arm, randomized study. Enrolled subjects will have a single Bone Marrow Lesion of the tibia, single BML of the femur, or adjoining Bone Marrow Lesions of tibia and femur. Subjects will also be surgical candidates for knee arthroscopy due to mechanical symptoms, meniscus tear, loose body and/or synovitis.
A stratified blocked randomization will be used to assign subjects to either Subchondroplasty with arthroscopy or to arthroscopy alone in a 2:1 ratio. Individual sets of blocks will be determined within study site and lesion polarity status (unipolar vs. bipolar).
Subjects will be enrolled within 60 days prior to surgery and take part in follow-up visits for two years following surgery. A preoperative visit will occur at the time of enrollment. Follow-up visits were to initially occur at the study site at 6 weeks, 3 months, 6 months, 12 months, and 24 months post-surgery. Telephone follow-up interviews to be be performed at 9 and 18 months post-surgery. Target enrollment was 201 subjects, to include 134 subjects in the treatment group (Subchondroplasty + Arthroscopy) and 67 subjects in the control group (Arthroscopy alone).
As of October 2020, follow-up has been amended to be completed remotely, where all visits can be performed electronically and/or via telephone.
Subjects will complete the study at the 24 month follow-up visit. For the purposes of this protocol, a revision will be defined as any partial or total joint arthroplasty or any bone fixation, bone grafting or bone substitute procedure in the same compartment in the study knee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subchondroplasty with Arthroscopy | Active Comparator | After randomization to the study group, subjects assigned to the Subchondroplasty + Arthroscopy group will undergo the Subchondroplasty portion of the procedure before or after the Arthroscopy portion per the surgeon's discretion. All operative procedures are to be performed under aseptic conditions according to the institution's standards. |
|
| Arthroscopy Alone | Sham Comparator | After randomization, subjects assigned to the Arthroscopy control group will undergo arthroscopy of the study knee with one or more of the following procedures:
Superficial skin incision(s) should be created at the typical AccuPort® access point(s) as if the subject had undergone Subchondroplasty. The incisions should be closed in the typical fashion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subchondroplasty with Arthroscopy | Procedure | The Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Clinical Success | The primary objective of this study is to determine whether Subchondroplasty with arthroscopy is superior to arthroscopy alone for treatment of bone marrow lesions in the knee. Superiority will be evaluated in terms of Composite Clinical Success (CCS) requiring freedom from subsequent secondary surgical intervention (SSSI) and among those free from SSSI, a clinically meaningful reduction in self-reported pain based on a validated measure of subject-reported pain (improvement in KOOS (Knee Injury and Osteoarthritis Outcome Score) pain of at least 10 points at 12 months). For the purpose of this study, SSSI will include any partial or total joint arthroplasty or any bone grafting or bone substitute procedure in the study knee. | Superiority will be statistically tested at month 12 at p<0.01 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline KOOS Subscale Scores at 12 Months | Comparison of mean change in KOOS subscale scores (Pain, Activities of Daily Living), Symptoms, Sports and Recreation, Quality of Life). Each subscale is scored from 0 to 100 on a worst to best scale. | 12 months post-surgery |
| Change From Baseline Numeric Pain Score at 12 Months |
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Inclusion Criteria:
Candidates must meet ALL of the following:
Voluntary signature of the Institutional Review Board/Research Ethics Board approved Informed Consent,
Male or female subjects between the ages of 30 to 75 years,
Body Mass Index ≤ 40 (BMI=kg/m2),
Has experienced pain in study knee for at least 3 months,
Kellgren-Lawrence grade 1-3 Osteoarthritis, as reviewed on preoperative XR imaging, in the study knee,
BML is confirmed on T2 weighted or Proton Density MR Imaging by presence of white signal,
Single BML of tibia, single BML of femur, or adjoining BML's of tibia & femur, in the same compartment, extending to the articular surface of the joint,
Surgical candidate for knee arthroscopy due to mechanical symptoms, meniscus tear, loose body and/or synovitis,
Must record a response, at the preoperative study visit, of moderate to extreme pain for any one of the KOOS Pain Scale questions, P2 through P9,
Index knee alignment is defined radiographically as one of the following: Neutral, ≤ 6° mechanical varus, or ≤ 6° mechanical valgus,
Ligaments in the study knee are stable,
The contralateral (non-study) knee is stable and functional,
Is refractory to conservative non-surgical management
Must be physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to be compliant with the protocol - including all follow-up visits, survey completion, weight-bearing restrictions, and post-operative rehabilitation.
Exclusion Criteria:
Candidates will be excluded if they meet ANY of the following:
BML caused by acute trauma less than 3 months prior to enrollment,
Clinical and/or radiographic disease diagnosis of the index knee that includes any of the following:
Passive knee flexion < 110° or flexion contracture >30°,
History of systemic diseases which could contribute to secondary arthropathies (e.g., sickle cell disease, hemochromatosis, or autoimmune disease),
Has a neuromuscular, neurosensory, or musculoskeletal deficiency that limits the ability to perform objective functional assessment of either knee,
If diabetic, blood glucose over 200 mg/dL at time of enrollment,
Current daily tobacco or high nicotine product user or < 3 months from nicotine cessation,
Presents a high surgical risk due to unstable cardiac and/or pulmonary disease,
Has HIV or other immunodeficient state including subjects on immunosuppressant therapies, or has significant illness (metastasis of any type) that decreases the probability of survival to the 2 year endpoint,
Is at substantial risk for the need of organ transplantation, such as renal insufficiency,
Is pregnant or breast-feeding at the time of surgery,
Has a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and with no clinical signs or symptoms of the malignancy for 5 years,
Has primary bone tumor in the knee area,
Anticipates having a lower extremity surgery other than the investigational surgery during the course of the study,
Is participating concurrently in another clinical trial, or has participated in a clinical trial within 30 days of surgery,
Is receiving prescription pain medication other than NSAIDs or acetaminophen for conditions unrelated to the index knee condition, chronic use of anticoagulants, or taking corticosteroids,
Active joint infection or history of chronic joint infection at the surgical site,
Prior total meniscectomy of index knee,
Has primarily patellofemoral symptoms,
Is indicated for concomitant procedures (i.e., microfracture, subchondral drilling, cartilage allograft, ligament or tendon repair, distal realignment/osteotomy, root repair) in the index knee, with the exception of incidental loose body removal, debridement, synovectomy, osteophyte removal in locations other than adjacent to BMLs, and/or partial meniscectomy,
Has contraindications for Magnetic Resonance Imaging (MRI),
Is receiving worker's compensation or is currently involved in litigation relating to the index knee,
Has a history of substance abuse.
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| Name | Affiliation | Role |
|---|---|---|
| Jason Dragoo, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CORE Orthopaedic Medical Center | Encinitas | California | 92024 | United States | ||
| Loma Linda University Health System |
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| ID | Title | Description |
|---|---|---|
| FG000 | Subchondroplasty With Arthroscopy | After randomization to the study group, subjects assigned to the Subchondroplasty + Arthroscopy group will undergo the Subchondroplasty portion of the procedure before or after the Arthroscopy portion per the surgeon's discretion. All operative procedures are to be performed under aseptic conditions according to the institution's standards. Subchondroplasty with Arthroscopy: The Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 | Oct 23, 2020 |
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A stratified blocked randomization will be used to assign subjects to either Subchondroplasty with arthroscopy or to arthroscopy alone in a 2:1 ratio. Individual sets of blocks will be determined within study site and lesion polarity status (unipolar vs. bipolar).
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The surgeon will be blinded to the treatment group until the time of surgery to avoid potential selection bias during the screening process. The subject will be blinded to the treatment group. The research coordinator will consult the central randomization list to determine which group the subject is in. Subjects may be randomized prior to surgery to allow for OR set-up. However, randomization should be performed as close to the time of surgery as possible to reduce the risk of randomization failures due to cancelled procedures.
|
| Arthroscopy Alone | Procedure | An endoscopic examination, therapy and surgery of the knee joint. |
|
Comparison of mean Numeric Pain Score (NPS). The NPS is scored from 0 to 10 where 0 indicates no pain; 5 indicates moderate pain; and 10 indicates the worst pain. |
| 12 months post-surgery |
| Change From Baseline EQ-5D Index Score at 12 Months | Comparison of mean EQ-5D Index score | 12 months post-surgery |
| Global Satisfaction Score at 6-Weeks | Patient satisfaction with knee procedure rated on a 0-10 scale, where 0 = totally dissatisfied and 10 = extremely satisfied. | 6-weeks post-surgery |
| Change From Baseline KOOS Subscale Scores at 24 Months | Comparison of mean change in KOOS subscale scores (Pain, Activities of Daily Living), Symptoms, Sports and Recreation, Quality of Life). Each subscale is scored from 0 to 100 on a worst to best scale. | 24 months post-surgery |
| Change From Baseline Numeric Pain Score at 24 Months | Comparison of mean Numeric Pain Score (NPS). The NPS is scored from 0 to 10 where 0 indicates no pain; 5 indicates moderate pain; and 10 indicates the worst pain. | 24 months post-surgery |
| Change From Baseline EQ-5D Overall Health Score at 12 Months | Comparison of mean EQ-5D Overall Health score using the EQ Visual Analog Scale (VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health). | 12 months post-surgery |
| Change From Baseline EQ-5D Overall Health Score at 24 Months | Comparison of mean EQ-5D Overall Health score using the EQ Visual Analog Scale (VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health). | 24 months post-surgery |
| Global Satisfaction Score at 3 Months | Patient satisfaction with knee procedure rated on a 0-10 scale, where 0 = totally dissatisfied and 10 = extremely satisfied. | 3 Months post-surgery |
| Global Satisfaction Score at 6 Months | Patient satisfaction with knee procedure rated on a 0-10 scale, where 0 = totally dissatisfied and 10 = extremely satisfied. | 6 months post-surgery |
| Global Satisfaction Score at 12 Months | Patient satisfaction with knee procedure rated on a 0-10 scale, where 0 = totally dissatisfied and 10 = extremely satisfied. | 12 months post-surgery |
| Global Satisfaction Score at 24 Months | Patient satisfaction with knee procedure rated on a 0-10 scale, where 0 = totally dissatisfied and 10 = extremely satisfied. | 24 months post-surgery |
| Loma Linda |
| California |
| 92354 |
| United States |
| Stanford University | Stanford | California | 94305 | United States |
| Foundation for Orthopaedic Research and Education | Tampa | Florida | 33637 | United States |
| Emory University | Atlanta | Georgia | 30329 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612-3833 | United States |
| MedStar Health Research Institute | Timonium | Maryland | 21093 | United States |
| New Mexico Orthopaedic Fellowship Foundation | Albuquerque | New Mexico | 87106 | United States |
| The Ohio State University | Columbus | Ohio | 43202 | United States |
| Hawkins Foundation | Greenville | South Carolina | 29615 | United States |
| Orthopedic Associates of Central Texas | Austin | Texas | 78745 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| Research St. Joseph's - Hamilton | Hamilton | Ontario | L8N4A6 | Canada |
| FG001 | Arthroscopy Alone | After randomization, subjects assigned to the Arthroscopy control group will undergo arthroscopy of the study knee with one or more of the following procedures:
Superficial skin incision(s) should be created at the typical AccuPort® access point(s) as if the subject had undergone Subchondroplasty. The incisions should be closed in the typical fashion. Arthroscopy Alone: An endoscopic examination, therapy and surgery of the knee joint. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Subchondroplasty With Arthroscopy | After randomization to the study group, subjects assigned to the Subchondroplasty + Arthroscopy group will undergo the Subchondroplasty portion of the procedure before or after the Arthroscopy portion per the surgeon's discretion. All operative procedures are to be performed under aseptic conditions according to the institution's standards. Subchondroplasty with Arthroscopy: The Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process. |
| BG001 | Arthroscopy Alone | After randomization, subjects assigned to the Arthroscopy control group will undergo arthroscopy of the study knee with one or more of the following procedures:
Superficial skin incision(s) should be created at the typical AccuPort® access point(s) as if the subject had undergone Subchondroplasty. The incisions should be closed in the typical fashion. Arthroscopy Alone: An endoscopic examination, therapy and surgery of the knee joint. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| KOOS Subscale Scores | KOOS Subscale Scores (Pain, Activities of Daily Living, Symptoms, Sports and Recreation, and Quality of Life) were collected at baseline and follow-up visits. Each subscale is scored from 0 to 100 on a worst to best scale. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Numeric Pain Score | Numeric Rating Scale (NRS) for pain, where patients rate their current knee pain from 0 (no pain) to 10 (worst imaginable pain). | Mean | Standard Deviation | Score (0-10) |
| ||||||||||||||||
| EQ-5D Index Score | The EQ-5D Index Score is a standardized measure of health-related quality of life derived from five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scores range from 0 (worst health state) to 1 (perfect health). | Mean | Standard Deviation | Index Score |
| ||||||||||||||||
| Imaging Completed at Baseline | Count of Participants | Participants |
| ||||||||||||||||||
| Number of Bone Lesions | Assessment of bone marrow lesions (BMLs) by MRI, reported as number of lesions per knee (e.g., 1 or 2). Location was recorded but not included in this measure. | Count of Participants | Participants |
| |||||||||||||||||
| EQ-5D Overall Health | Patient-reported overall health status measured using the EQ Visual Analog Scale (VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health). | Mean | Standard Deviation | Points on a scale (0-100) |
|
| 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 | Composite Clinical Success | The primary objective of this study is to determine whether Subchondroplasty with arthroscopy is superior to arthroscopy alone for treatment of bone marrow lesions in the knee. Superiority will be evaluated in terms of Composite Clinical Success (CCS) requiring freedom from subsequent secondary surgical intervention (SSSI) and among those free from SSSI, a clinically meaningful reduction in self-reported pain based on a validated measure of subject-reported pain (improvement in KOOS (Knee Injury and Osteoarthritis Outcome Score) pain of at least 10 points at 12 months). For the purpose of this study, SSSI will include any partial or total joint arthroplasty or any bone grafting or bone substitute procedure in the study knee. | Posted | Count of Participants | Participants | Superiority will be statistically tested at month 12 at p<0.01 |
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| Secondary | Change From Baseline KOOS Subscale Scores at 12 Months | Comparison of mean change in KOOS subscale scores (Pain, Activities of Daily Living), Symptoms, Sports and Recreation, Quality of Life). Each subscale is scored from 0 to 100 on a worst to best scale. | Posted | Mean | Standard Deviation | score on a scale | 12 months post-surgery |
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| Secondary | Change From Baseline Numeric Pain Score at 12 Months | Comparison of mean Numeric Pain Score (NPS). The NPS is scored from 0 to 10 where 0 indicates no pain; 5 indicates moderate pain; and 10 indicates the worst pain. | Posted | Mean | Standard Deviation | score on a scale (0-10) | 12 months post-surgery |
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| Secondary | Change From Baseline EQ-5D Index Score at 12 Months | Comparison of mean EQ-5D Index score | Posted | Mean | Standard Deviation | Index score | 12 months post-surgery |
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| Secondary | Global Satisfaction Score at 6-Weeks | Patient satisfaction with knee procedure rated on a 0-10 scale, where 0 = totally dissatisfied and 10 = extremely satisfied. | Posted | Mean | Standard Deviation | Score on a scale (0-10) | 6-weeks post-surgery |
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| Secondary | Change From Baseline KOOS Subscale Scores at 24 Months | Comparison of mean change in KOOS subscale scores (Pain, Activities of Daily Living), Symptoms, Sports and Recreation, Quality of Life). Each subscale is scored from 0 to 100 on a worst to best scale. | Posted | Mean | Standard Deviation | score on a scale | 24 months post-surgery |
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| Secondary | Change From Baseline Numeric Pain Score at 24 Months | Comparison of mean Numeric Pain Score (NPS). The NPS is scored from 0 to 10 where 0 indicates no pain; 5 indicates moderate pain; and 10 indicates the worst pain. | Posted | Mean | Standard Deviation | score on a scale (0-10) | 24 months post-surgery |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline EQ-5D Overall Health Score at 12 Months | Comparison of mean EQ-5D Overall Health score using the EQ Visual Analog Scale (VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health). | Posted | Mean | Standard Deviation | Points (0-100) | 12 months post-surgery |
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| Secondary | Change From Baseline EQ-5D Overall Health Score at 24 Months | Comparison of mean EQ-5D Overall Health score using the EQ Visual Analog Scale (VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health). | Posted | Mean | Standard Deviation | Points (0-100) | 24 months post-surgery |
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| Secondary | Global Satisfaction Score at 3 Months | Patient satisfaction with knee procedure rated on a 0-10 scale, where 0 = totally dissatisfied and 10 = extremely satisfied. | Posted | Mean | Standard Deviation | Score on a scale (0-10) | 3 Months post-surgery |
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| Secondary | Global Satisfaction Score at 6 Months | Patient satisfaction with knee procedure rated on a 0-10 scale, where 0 = totally dissatisfied and 10 = extremely satisfied. | Posted | Mean | Standard Deviation | Score on a scale (0-10) | 6 months post-surgery |
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| Secondary | Global Satisfaction Score at 12 Months | Patient satisfaction with knee procedure rated on a 0-10 scale, where 0 = totally dissatisfied and 10 = extremely satisfied. | Posted | Mean | Standard Deviation | Score on a scale (0-10) | 12 months post-surgery |
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| Secondary | Global Satisfaction Score at 24 Months | Patient satisfaction with knee procedure rated on a 0-10 scale, where 0 = totally dissatisfied and 10 = extremely satisfied. | Posted | Mean | Standard Deviation | Score on a scale (0-10) | 24 months post-surgery |
|
Adverse event data were collected for the operative, 6-week, 3-month, 6-month, 9-month, 12-month, 18-month, and 24-month windows.
Adverse events were collected during the operative and postoperative periods. Operative events were documented by the surgical team during hospitalization. Postoperative events were assessed via structured telephone interviews at 6 weeks and 3, 6, 9, 12, 18, and 24 months. All adverse events that were collected are reported in this record.
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| 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 Arthroscopy | After randomization to the study group, subjects assigned to the Subchondroplasty + Arthroscopy group will undergo the Subchondroplasty portion of the procedure before or after the Arthroscopy portion per the surgeon's discretion. All operative procedures are to be performed under aseptic conditions according to the institution's standards. Subchondroplasty with Arthroscopy: The Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process. | 0 | 88 | 13 | 88 | 30 | 88 |
| EG001 | Arthroscopy Alone | After randomization, subjects assigned to the Arthroscopy control group will undergo arthroscopy of the study knee with one or more of the following procedures:
Superficial skin incision(s) should be created at the typical AccuPort® access point(s) as if the subject had undergone Subchondroplasty. The incisions should be closed in the typical fashion. Arthroscopy Alone: An endoscopic examination, therapy and surgery of the knee joint. | 0 | 43 | 5 | 43 | 14 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Total knee replacement (study knee) | Surgical and medical procedures | Systematic Assessment |
| ||
| Displaced MFC fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Medial femoral condyle fracture during postoperative period resulting in total knee arthroplasty. |
| |
| Revision amputation, left small finger at middle phalanx | Injury, poisoning and procedural complications | Systematic Assessment | Table saw laceration to middle phalanx of left small finger leading to revision amputation due to extended time between encounter and injury (over 24 hours). |
| |
| Total knee arthroplasty (contralateral, non-study knee) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Right arm fracture requiring ORIF | Injury, poisoning and procedural complications | Systematic Assessment | Right arm fractures of the radius and ulna secondary to bicycle accident. |
| |
| Right breast cancer with surgical intervention and radiation therapy | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Unicompartmental knee arthroplasty (study knee) | Musculoskeletal and connective tissue disorders | Systematic Assessment | Ongoing pain following study surgery due to medial compartment arthritis |
| |
| Right rotator cuff repair, biceps tenodesis | Surgical and medical procedures | Systematic Assessment |
| ||
| Knee debridement, medial and lateral meniscectomy (contralateral, non-study knee) | Surgical and medical procedures | Systematic Assessment |
| ||
| L1 vertebral fracture due to osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Surgical repair |
| |
| Knee arthroscopy, lysis of adhesions, anterior notch adhesions, & manipulation under anesthesia | Surgical and medical procedures | Systematic Assessment | Treatment of flexion contracture, study knee |
| |
| Severe back and leg pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Occurred postoperatively |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Knee Effusion (possibly, probably, or definitely related) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| AccuFill Leakage (possibly, probably, or definitely related) | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Deep Vein Thrombosis (possibly, probably, or definitely related) | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pulmonary Embolism (possibly, probably, or definitely related) | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Knee Osteoarthritis (possibly, probably, or definitely related) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Increased knee pain (possibly, probably, or definitely related) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Stiffness with flexion contracture (possibly, probably, or definitely related) | Musculoskeletal and connective tissue disorders | Systematic Assessment | 10 weeks status-post arthroscopy/subchondroplasty |
| |
| Extravasation of cement material during implantation (possibly, probably, or definitely related) | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Cubital and carpal tunnel syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Increased Pain (non-knee, not related) | General disorders | Systematic Assessment |
| ||
| Increased knee pain (not related) | Musculoskeletal and connective tissue disorders | Systematic Assessment | Secondary to collapse of weight bearing medial femoral condyle of knee |
| |
| Osteoarthritis (not related) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Fall, accident, or collision | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Knee effusion (not related) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Knee Bursitis (not related) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Rotator cuff issue | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Lumbago with sciatica | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| AccuFill Leakage (not related) | Injury, poisoning and procedural complications | Systematic Assessment |
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| Left foot numbness | Musculoskeletal and connective tissue disorders | Systematic Assessment | "Sock distribution", previously only numbness in big toe |
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| Throbbing pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Right lower leg |
| |
| L1 Fracture | Injury, poisoning and procedural complications | Systematic Assessment | requiring surgical intervention |
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| Psoas tendinitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| Acute midline low back pain with left-sided sciatica | Musculoskeletal and connective tissue disorders | Systematic Assessment | With medical history of spinal stenosis |
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| Total knee arthroplasty (not related) | Surgical and medical procedures | Systematic Assessment |
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| Knee swelling (not related) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hip and low back pain (not related) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Lumbar spondylosis | Musculoskeletal and connective tissue disorders | Systematic Assessment | "due to fall" |
| |
| Acute choking while eating | Injury, poisoning and procedural complications | Systematic Assessment | While in the ED, patient expelled food bolus by vomitting with complete resolution of symptoms |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annette Tieu | Zimmer Biomet | 971-482-9622 | annette.tieu@zimmerbiomet.com |
| Sep 16, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001182 | Arthroscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019637 | Orthopedic Procedures |
Not provided
Not provided
| >=65 years |
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| Male |
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| Asian |
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| Black or African American |
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| Decline to Respond |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Hispanic or Latino |
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| United States |
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| Activities of Daily Living |
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| Symptoms |
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| Sports and Recreation |
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| Quality of Life |
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| 2 |
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| Did not answer |
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