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Bone Marrow LesionsNCT03430219

Subchondroplasty Procedure in Patients With Bone Marrow Lesions

An observational study of Bone Marrow Lesions and Bone Marrow Edema, run by Zimmer Biomet at 6 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bone Marrow Lesions, Bone Marrow Edema
What is being tested?
Subchondroplasty Procedure
How many people
93 participants
Where
6 sitesin 5 countries
Study dates
1 Mar 2018to 16 Mar 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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)
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  • 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)

Who cannot join

  • 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
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  • 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

Trial locations and contacts

6 sites in 5 countries.

6 sites in 5 countries

United Kingdom2 sites

  • Gloucestershire Hospitals NHS

    Cheltenham

  • Harrogate & District NHS FOUNDATION TRUST

    Leeds

Other trials in United Kingdom

Germany1 site

  • Universitaetsklinikum Regensburg

    Regensburg

Other trials in Germany

Italy1 site

  • Istituto Clinico Humanitas

    Rozzano (MI)

Other trials in Italy

Netherlands1 site

  • Maastricht UMC

    Maastricht

Other trials in Netherlands

Spain1 site

  • Hospital Universitari Vall d´Hebron

    Barcelona

Other trials in Spain

About this study

Official title: Prospective Post-Market Data Collection on Patients With Bone Marrow Lesions (BMLs) in the Knee Treated With the Subchondroplasty® (SCP®) Procedure

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.

Read the 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.

Being tested
Subchondroplasty Procedure
Keywords
AccuFill, Injectable Calcium Phosphate, Subchondroplasty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Subchondroplasty ProcedureDevice

    Also called AccuFill Injectable Calcium Phosphate

    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

Study groups in NCT03430219
Study groupRoleWhat they receive
Subchondroplasty ProcedureThe SCP Procedure targets and fills bone defects with AccuFill bone substitute material utilizing an arthroscopic / percutaneous approach
Receives: Device: Subchondroplasty Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (15)

  1. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Change in KOOS pain and function subscales and overall scores. 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.

    Measured: 2 year

  2. Numerical Rating Scale (NRS) pain scale

    Change in pain as measured by NRS pain scale. The NRS is a validated measure of knee pain. The NRS is an 11 point Likert type scale anchored by 0 "no pain" and 10 "worst possible pain". Subjects rate their average pain over the last week

    Measured: 2 year

  3. EuroQol-5 Dimensions (EQ-5D)

    Change in quality of life as measured by EQ-5D. The EQ-5D is a validated instrument that assesses an individual's current health status and heath related quality of life. The EQ-5D-5L descriptive component assesses five dimensions:

    mobility, self-care, usual activities, pain/discomfort, and anxiety/depression over five levels of severity

    Measured: 2 year

  4. Heath care utilization Questionnaire

    Healthcare utilization for each subject will be recorded via a not validated questionnaire to capture information about any treatments, therapies, specialists, etc. utilized for pain or symptom relief following study treatment and follow-up.

    Measured: 2 year

  5. Subject global satisfaction Questionnaire

    The subject global satisfaction is concerned with determining patient-related factors such as patients' satisfaction with treatment, and experienced health outcomes. The questionnaire uses a not validated 11 point scale anchored by 0 "totally dissatisfied" and 10 "extremely satisfied".

    Measured: 2 year

  6. Occurrence of Re-operations

    Occurrence of subjects that require any re-operation on the index knee from initial SCP Procedure.

    Measured: 2 year

  7. Time to Re-operations

    Time from initial SCP Procedure to any re-operation

    Measured: 2 year

  8. Occurrence of Revisions

    Occurrence of subjects that require revision on the index knee from initial SCP Procedure.

    Measured: 2 year

  9. Time to Revisions

    Time from initial SCP Procedure to revisions

    Measured: 2 year

  10. X-ray

    X-ray evaluation of alignment, joint space narrowing, osteophyte and cyst formation and subchondral sclerosis

    Measured: 12 months

  11. MRI BML lesion size

    MRI evaluation of Bone Marrow Lesion Size

    Measured: 12 months

  12. MRI BML type

    MRI evaluation of Bone Marrow Lesion Type

    Measured: 12 months

  13. MRI Intraosseous vascularity

    MRI evaluation of Intraosseous Vascularity

    Measured: 12 months

  14. MRI location of injectate

    MRI evaluation of Location of Injectate.

    Measured: 12 months

  15. Adverse Events

    Occurrence of Adverse Events

    Measured: 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2018
  2. Study start1 Mar 2018
  3. Primary completion16 Mar 2023
  4. Study completion16 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03430219
Sponsor's protocol ID
SCP-EMEA-01
Status last verified
Jun 2023
First submitted
11 Jan 2018
Last updated
22 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Di Matteo B, Anzillotti G, Conte P, Angele P, Emans P, Minguell-Monyart J, Woodell-May J, Correa-Tapia M, Kon E. Subchondroplasty(R) (SCP) Provides Resolution of Symptoms and Functional Improvements in Mild-to-Moderate Knee Osteoarthritis with Persistent Bone Marrow Lesions: 12-Month Follow-Up Results from a Multicentric Open-Label Prospective Clinical Trial. Cartilage. 2025 Jun;16(2):181-189. doi: 10.1177/19476035241264011. Epub 2024 Jul 30.

    PubMed 39076070

Questions about this trial

What is this clinical trial studying?

An observational study of Bone Marrow Lesions and Bone Marrow Edema, run by Zimmer Biomet at 6 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United Kingdom, Germany, Italy, Netherlands, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03430219, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

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