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Subchondroplasty Procedure in Patients With Bone Marrow Lesions

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ClinicalTrials.gov Identifier: NCT03430219
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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.

Condition or disease Intervention/treatment
Bone Marrow Lesions Bone Marrow Edema Device: Subchondroplasty 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 250 patients across 10 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 annually up to 5 years post injection; and subjects will be asked questions regarding their pain and functioning to further understand long-term outcomes.

For a subset of approximately 100 consecutive subjects at selected centers, a long standing X-ray and MRI at screening and 12 months will be obtained.


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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Post-Market Data Collection on Patients With Bone Marrow Lesions (BMLs) in the Knee Treated With the Subchondroplasty® (SCP®) Procedure
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Group/Cohort Intervention/treatment
Subchondroplasty Procedure
The SCP Procedure targets and fills bone defects with AccuFill bone substitute material utilizing an arthroscopic / percutaneous approach
Device: 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
Other Name: AccuFill Injectable Calcium Phosphate




Primary Outcome Measures :
  1. Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 5 year ]
    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.

  2. Numerical Rating Scale (NRS) pain scale [ Time Frame: 5 year ]
    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

  3. EuroQol-5 Dimensions (EQ-5D) [ Time Frame: 5 year ]

    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


  4. Heath care utilization Questionnaire [ Time Frame: 5 year ]
    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.

  5. Subject global satisfaction Questionnaire [ Time Frame: 5 year ]
    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".

  6. Occurrence of Re-operations [ Time Frame: 5 year ]
    Occurrence of subjects that require any re-operation on the index knee from initial SCP Procedure.

  7. Time to Re-operations [ Time Frame: 5 year ]
    Time from initial SCP Procedure to any re-operation

  8. Occurrence of Revisions [ Time Frame: 5 year ]
    Occurrence of subjects that require revision on the index knee from initial SCP Procedure.

  9. Time to Revisions [ Time Frame: 5 year ]
    Time from initial SCP Procedure to revisions

  10. X-ray [ Time Frame: 12 months ]
    X-ray evaluation of alignment, joint space narrowing, osteophyte and cyst formation and subchondral sclerosis

  11. MRI BML lesion size [ Time Frame: 12 months ]
    MRI evaluation of Bone Marrow Lesion Size

  12. MRI BML type [ Time Frame: 12 months ]
    MRI evaluation of Bone Marrow Lesion Type

  13. MRI Intraosseous vascularity [ Time Frame: 12 months ]
    MRI evaluation of Intraosseous Vascularity

  14. MRI location of injectate [ Time Frame: 12 months ]
    MRI evaluation of Location of Injectate.

  15. Adverse Events [ Time Frame: 5 year ]
    Occurrence of Adverse Events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with symptomatic BML(s) of the knee(s) who qualify for a SCP Procedure.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430219


Contacts
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Contact: Linda Korthout +31610072.853 linda.korthout@zimmerbiomet.com
Contact: Cahit Akbas +31622981737 cahit.akbas@zimmerbiomet.com

Locations
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Germany
Universitaetsklinikum Regensburg Recruiting
Regensburg, Germany
Contact: Peter Angele, MD         
Italy
Istituto Clinico Humanitas Recruiting
Rozzano (MI), Italy
Contact: Elizaveta Kon, MD         
Netherlands
Maastricht UMC Recruiting
Maastricht, Netherlands
Contact: Pieter Emans, MD         
Spain
Hospital Universitari Vall d´Hebron Recruiting
Barcelona, Spain
Contact: Joan Minguell, MD         
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Principal Investigator: Peter Angele, Prof.Dr.med University of Regensburg

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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT03430219     History of Changes
Other Study ID Numbers: SCP-EMEA-01
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zimmer Biomet:
AccuFill
Injectable Calcium Phosphate
Subchondroplasty
Additional relevant MeSH terms:
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Calcium, Dietary
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents