Subchondroplasty Procedure in Patients With Bone Marrow Lesions

Prospective Post-Market Data Collection on Patients With Bone Marrow Lesions (BMLs) in the Knee Treated With the Subchondroplasty® (SCP®) Procedure

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.

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.

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