Bone Marrow Edema Clinical Trial
Official title:
Prospective Post-Market Data Collection on Patients With Bone Marrow Lesions (BMLs) in the Knee Treated With the Subchondroplasty® (SCP®) Procedure
NCT number | NCT03430219 |
Other study ID # | SCP-EMEA-01 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2018 |
Est. completion date | March 16, 2023 |
Verified date | June 2023 |
Source | Zimmer Biomet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 93 |
Est. completion date | March 16, 2023 |
Est. primary completion date | March 16, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Universitaetsklinikum Regensburg | Regensburg | |
Italy | Istituto Clinico Humanitas | Rozzano (MI) | |
Netherlands | Maastricht UMC | Maastricht | |
Spain | Hospital Universitari Vall d´Hebron | Barcelona | |
United Kingdom | Gloucestershire Hospitals NHS | Cheltenham | |
United Kingdom | Harrogate & District NHS FOUNDATION TRUST | Leeds |
Lead Sponsor | Collaborator |
---|---|
Zimmer Biomet |
Germany, Italy, Netherlands, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale | 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. | 12 months | |
Secondary | Knee Injury and Osteoarthritis Outcome Score (KOOS) | 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. | 2 year | |
Secondary | Numerical Rating Scale (NRS) pain scale | 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 | 2 year | |
Secondary | EuroQol-5 Dimensions (EQ-5D) | 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 |
2 year | |
Secondary | Heath care utilization Questionnaire | 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. | 2 year | |
Secondary | Subject global satisfaction Questionnaire | 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". | 2 year | |
Secondary | Occurrence of Re-operations | Occurrence of subjects that require any re-operation on the index knee from initial SCP Procedure. | 2 year | |
Secondary | Time to Re-operations | Time from initial SCP Procedure to any re-operation | 2 year | |
Secondary | Occurrence of Revisions | Occurrence of subjects that require revision on the index knee from initial SCP Procedure. | 2 year | |
Secondary | Time to Revisions | Time from initial SCP Procedure to revisions | 2 year | |
Secondary | X-ray | X-ray evaluation of alignment, joint space narrowing, osteophyte and cyst formation and subchondral sclerosis | 12 months | |
Secondary | MRI BML lesion size | MRI evaluation of Bone Marrow Lesion Size | 12 months | |
Secondary | MRI BML type | MRI evaluation of Bone Marrow Lesion Type | 12 months | |
Secondary | MRI Intraosseous vascularity | MRI evaluation of Intraosseous Vascularity | 12 months | |
Secondary | MRI location of injectate | MRI evaluation of Location of Injectate. | 12 months | |
Secondary | Adverse Events | Occurrence of Adverse Events | 2 year |
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