Prospective Post-Market Data Collection on Patients with Bone Marrow Lesions in the Knee Treated with Subchondroplasty procedure
- Conditions
- Bone marrow lesion | Bone defect10005959
- Registration Number
- NL-OMON52931
- Lead Sponsor
- Zimmer Biomet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
- 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, <= 6° mechanical varus, or <= 6° mechanical valgus
- A KOOS Pain subscale total score < 70
- Is refractory to conservative non-surgical management of BML:
- having failed 2 or more of the following: hyaluronic acid (HA) injection,
corti-costeroid injection, non-steroidal anti-inflammatory drugs (NSAIDs),
physical therapy, bracing, or minimal surgical intervention (e.g. arthroscopy,
debride-ment/chondroplasty, and/or loose body removal)
- and diagnosis of BML is >= 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)
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale:<br /><br>KOOS is a validated instrument which measures knee pain and function using five<br /><br>subscales: pain, symptoms, function in daily living, function in sport and<br /><br>recreation, and quality of life. The instrument consists of 42 standardized<br /><br>questions each having 5 point Likert response scale. </p><br>
- Secondary Outcome Measures
Name Time Method