Status
Conditions
Treatments
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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:
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:
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
93 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal