Bone marrow lesion | Bone defect
Conditions
Interventions
Subchondroplasty (SCP) to fill subchondral osseous defects associated with BMLs
using an injectable bone substitute material (BSM), AccuFill.
Sponsors
Zimmer Biomet
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 ar-ticular surface of the joint confirmed on T2 weighted fat-suppressed or Proton Density MR Imaging by presence of white signal - Index knee alignment is defined radiographically as one of the following: Neutral, = 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
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 osteoarthritis (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 OA1 - 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, , 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 |
|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale: 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 |
|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS): 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. EuroQol-5 Dimensions (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. Numeric Rating Scale (NRS) for pain: 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. Heathcare Utilization: Health economics will be evaluated throughout the study. Healthcare utilization for each subject will be recorded to capture information about their use of healthcare resources following study treatment and follow-up. Subject Global Satisfaction Scale: The subject global satisfaction is concerned with determining patient-related factors such as patients* satisfaction with treatment, and experienced health outcomes. Patient preferences will be measured utilizing questions to elicit patient satisfaction following a SCP Procedure within the study. Knee Radiograph A long standing anterior-posterior (AP) fixed flexion radiograph of the index knee is acquired. Alignment and K-L grade will be measured according to validated, prospectively defined techniques described in signed charters produced by the Imaging Core Laboratory. This charter will specify radiograph acquisition details, transfer, and analysis techniques. All X-rays will be transferred to the Imaging Core Laboratory for independent re- view. Radiographs will be taken for a subset of sub | — |
Countries
Netherlands
Outcome results
None listed