Bone Marrow Edema, Bone Marrow Lesions
Conditions
Keywords
AccuFill, Injectable Calcium Phosphate, Subchondroplasty
Brief summary
This is a prospective, multi-center, post-market data collection study intended to collect data on the short- and long-term safety and performance of the SCP Procedure.
Detailed description
Patients with symptomatic BML(s) of the knee(s) who qualify for a SCP Procedure will be invited to participate. This study will enroll up to 95 patients across 4 investigative centers in Europe over a period of 12 months. The maximum study duration is expected to be 6 years. Follow-up assessments will be conducted at 1 month, 3, 6, 12-months and 24-months post injection; and subjects will be asked questions regarding their pain and functioning to further understand long-term outcomes. For all subjects at selected centers, a long standing X-ray and MRI at screening and either at 12 months or 24 months will be obtained.
Interventions
DEVICESubchondroplasty Procedure
AccuFill is an injectable, self-setting, macro-porous, osteoconductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the lower extremities (pelvis through foot) that are not intrinsic to the stability of the bony structure
Sponsors
Zimmer Biomet
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age at time of screening * Patient with BML(s) in one or both knees, as diagnosed by the treating physician, willing and eligible to undergo the SCP Procedure * One or more BML(s) of the tibial plateau and/or femoral condyle extending to the articular surface of the joint confirmed on T2 weighted fat-suppressed or fat-suppressed Proton Density MR Imaging by presence of white signal * Patient's index knee alignment, which is defined radiographically, must be one of the following: Neutral, 6 degree mechanical varus, or 6 degree mechanical valgus * Patient is refractory to conservative non-surgical management of BML: * Having failed 2 or more of the following: hyaluronic acid (HA) injection, corticosteroid injection, non-steroidal anti-inflammatory drugs (NSAIDs), physical therapy, bracing, or minimal surgical intervention (e.g. arthroscopy, debridement/chondroplasty, and/or loose body removal) * and diagnosis of BML is more than 3 months of the study treatment * Willing and able to comply with the study procedures * Signed an informed consent form approved by independent ethics committee (IEC)
Exclusion criteria
* Existing acute or chronic infections at the surgical site * Bone in the index knee is non-viable or not capable of supporting and anchoring the implant. * Known systemic disorders or any systemic inflammatory condition (e.g. rheumatoid arthritis) * Acute traumatic injuries with open wounds close to the bone defect which are likely to become infected * Known metabolic bone disease, including disorders in calcium metabolism * Known immunologic abnormalities, including inflammatory bone disease * 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 * Diagnosis of patella-femoral joint OA and/or primarily patella-femoral symptoms * 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: * Kellgren-Lawrence grade 4 Osteoarthritis (OA) * BML located at anterior cruciate ligament (ACL)/ posterior cruciate ligament (PCL) insertion * Any major or cartilage repair or alignment surgery (i.e. osteotomy, autograft, scaffold, marrow stimulation, debridement, all cell-based therapies, etc.) of the index knee within 12 months prior to enrollment * Pregnant at time of injection * Lactating at time of injection * Use of any investigational drug or device within 30 days prior to enrollment * Use of any investigational biologics within 30 days prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale | 12 months | Change in pain following SCP Procedure as measured by the KOOS pain subscale. The KOOS is a validated instrument which measures knee pain and function using five subscales: pain, symptoms, function in daily living, function in sport and recreation, and quality of life. The instrument consists of 42 standardized questions each having 5 point Likert response scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 2 year | Occurrence of Adverse Events |
| X-ray | 12 months | X-ray evaluation of alignment, joint space narrowing, osteophyte and cyst formation and subchondral sclerosis |
| MRI BML lesion size | 12 months | MRI evaluation of Bone Marrow Lesion Size |
| MRI BML type | 12 months | MRI evaluation of Bone Marrow Lesion Type |
| MRI Intraosseous vascularity | 12 months | MRI evaluation of Intraosseous Vascularity |
| Time to Re-operations | 2 year | Time from initial SCP Procedure to any re-operation |
| Occurrence of Revisions | 2 year | Occurrence of subjects that require revision on the index knee from initial SCP Procedure. |
| MRI location of injectate | 12 months | MRI evaluation of Location of Injectate. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | 2 year | Change in KOOS pain and function subscales and overall scores. The KOOS is a validated instrument which measures knee pain and function using five subscales: pain, symptoms, function in daily living, function in sport and recreation, and quality of life. The instrument consists of 42 standardized questions each having 5 point Likert response scale. |
| Numerical Rating Scale (NRS) pain scale | 2 year | Change in pain as measured by NRS pain scale. The NRS is a validated measure of knee pain. The NRS is an 11 point Likert type scale anchored by 0 no pain and 10 worst possible pain. Subjects rate their average pain over the last week |
| EuroQol-5 Dimensions (EQ-5D) | 2 year | Change in quality of life as measured by EQ-5D. The EQ-5D is a validated instrument that assesses an individual's current health status and heath related quality of life. The EQ-5D-5L descriptive component assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression over five levels of severity |
| Heath care utilization Questionnaire | 2 year | Healthcare utilization for each subject will be recorded via a not validated questionnaire to capture information about any treatments, therapies, specialists, etc. utilized for pain or symptom relief following study treatment and follow-up. |
| Subject global satisfaction Questionnaire | 2 year | The subject global satisfaction is concerned with determining patient-related factors such as patients' satisfaction with treatment, and experienced health outcomes. The questionnaire uses a not validated 11 point scale anchored by 0 totally dissatisfied and 10 extremely satisfied. |
| Occurrence of Re-operations | 2 year | Occurrence of subjects that require any re-operation on the index knee from initial SCP Procedure. |
| Time to Revisions | 2 year | Time from initial SCP Procedure to revisions |
Countries
Germany, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed