Status:
COMPLETED
Subchondroplasty Procedure in Patients With Bone Marrow Lesions
Lead Sponsor:
Zimmer Biomet
Conditions:
Bone Marrow Lesions
Bone Marrow Edema
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 16 2023
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT03430219
Start Date
March 1 2018
End Date
March 16 2023
Last Update
June 22 2023
Active Locations (6)
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1
Universitaetsklinikum Regensburg
Regensburg, Germany
2
Istituto Clinico Humanitas
Rozzano (MI), Italy
3
Maastricht UMC
Maastricht, Netherlands
4
Hospital Universitari Vall d´Hebron
Barcelona, Spain