Clinical trial NCT03430219: Subchondroplasty Procedure in Patients With Bone Marrow Lesions
Official title: Prospective Post-Market Data Collection on Patients With Bone Marrow Lesions (BMLs) in the Knee Treated With the Subchondroplasty® (SCP®) Procedure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Marrow Lesions
Bone Marrow Edema
Keywords: AccuFill
Injectable Calcium Phosphate
Subchondroplasty
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2018-02-12
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with symptomatic BML(s) of the knee(s) who qualify for a SCP Procedure.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale
timeFrame: 12 months
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 2 year
measure: Numerical Rating Scale (NRS) pain scale
timeFrame: 2 year
measure: EuroQol-5 Dimensions (EQ-5D)
timeFrame: 2 year
measure: Heath care utilization Questionnaire
timeFrame: 2 year
measure: Subject global satisfaction Questionnaire
timeFrame: 2 year
measure: Occurrence of Re-operations
timeFrame: 2 year
measure: Time to Re-operations
timeFrame: 2 year
measure: Occurrence of Revisions
timeFrame: 2 year
measure: Time to Revisions
timeFrame: 2 year
measure: X-ray
timeFrame: 12 months
measure: MRI BML lesion size
timeFrame: 12 months
measure: MRI BML type
timeFrame: 12 months
measure: MRI Intraosseous vascularity
timeFrame: 12 months
measure: MRI location of injectate
timeFrame: 12 months
measure: Adverse Events
timeFrame: 2 year
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: Universitaetsklinikum Regensburg
city: Rozzano (MI)
country: Italy
facility: Istituto Clinico Humanitas
city: Maastricht
country: Netherlands
facility: Maastricht UMC
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d´Hebron
city: Cheltenham
country: United Kingdom
facility: Gloucestershire Hospitals NHS
city: Leeds
country: United Kingdom
facility: Harrogate & District NHS FOUNDATION TRUST
Study officials:
affiliation: University of Regensburg
name: Peter Angele, Prof.Dr.med
role: PRINCIPAL_INVESTIGATOR
References: