Subchondroplasty Procedure in Patients With Bone Marrow Lesions

NCT03430219 | Completed

• 1 other identifier: SCP-EMEA-01
• Study Type: observational
• Target: 93
• Locations: 5 countries
• Sites: 6

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.

Conditions

Bone Marrow Lesions; Bone Marrow Edema

Keywords

AccuFill; Injectable Calcium Phosphate; Subchondroplasty

Outcome Measures

Primary Outcomes (1)

• Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale

  Change in pain following SCP Procedure as measured by the KOOS pain subscale. The KOOS is a validated instrument which measures knee pain and function using five subscales: pain, symptoms, function in daily living, function in sport and recreation, and quality of life. The instrument consists of 42 standardized questions each having 5 point Likert response scale.

  12 months

Secondary Outcomes (15)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  2 year

• Numerical Rating Scale (NRS) pain scale

  2 year

• EuroQol-5 Dimensions (EQ-5D)

  2 year

• Heath care utilization Questionnaire

  2 year

• Subject global satisfaction Questionnaire

  2 year

Study Arms (1)

Subchondroplasty Procedure

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

Device: Subchondroplasty Procedure

Interventions

Subchondroplasty Procedure 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

Also known as: AccuFill Injectable Calcium Phosphate

Subchondroplasty Procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with symptomatic BML(s) of the knee(s) who qualify for a SCP Procedure.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (6)

Universitaetsklinikum Regensburg

Regensburg, Germany

Location

Istituto Clinico Humanitas

Rozzano (MI), Italy

Location

Maastricht UMC

Maastricht, Netherlands

Location

Hospital Universitari Vall d´Hebron

Barcelona, Spain

Location

Gloucestershire Hospitals NHS

Cheltenham, United Kingdom

Location

Harrogate & District NHS FOUNDATION TRUST

Leeds, United Kingdom

Location

Study Officials

• Peter Angele, Prof.Dr.med

  University of Regensburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: February 12, 2018
• Study Start: March 1, 2018
• Primary Completion: March 16, 2023
• Study Completion: March 16, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

IT (1); GB (2); DE (1); ES (1); NL (1)