Subchondroplasty Procedure in Patients With Bone Marrow Lesions

NCT ID: NCT03430219

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 93 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2023-03-16

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.

Conditions

Bone Marrow Lesions; Bone Marrow Edema

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Subchondroplasty Procedure

The SCP Procedure targets and fills bone defects with AccuFill bone substitute material utilizing an arthroscopic / percutaneous approach

Subchondroplasty Procedure

Intervention Type: DEVICE

AccuFill is an injectable, self-setting, macro-porous, osteoconductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the lower extremities (pelvis through foot) that are not intrinsic to the stability of the bony structure

Interventions

Subchondroplasty Procedure

AccuFill is an injectable, self-setting, macro-porous, osteoconductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the lower extremities (pelvis through foot) that are not intrinsic to the stability of the bony structure

Intervention Type: DEVICE

Other Intervention Names

AccuFill Injectable Calcium Phosphate

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Angele, Prof.Dr.med

Role: PRINCIPAL_INVESTIGATOR

University of Regensburg

Locations

Universitaetsklinikum Regensburg

Regensburg, , Germany

Istituto Clinico Humanitas

Rozzano (MI), , Italy

Maastricht UMC

Maastricht, , Netherlands

Hospital Universitari Vall d´Hebron

Barcelona, , Spain

Gloucestershire Hospitals NHS

Cheltenham, , United Kingdom

Harrogate & District NHS FOUNDATION TRUST

Leeds, , United Kingdom

Countries

Germany; Italy; Netherlands; Spain; United Kingdom

Other Identifiers

SCP-EMEA-01

Identifier Type: -

Identifier Source: org_study_id