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Subchondroplasty Procedure in Patients With Bone Marrow Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date January 11, 2018
First Posted Date February 12, 2018
Last Update Posted Date January 23, 2019
Actual Study Start Date March 1, 2018
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 5, 2018)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03430219 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 26, 2018)
  • 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.
  • 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
  • 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
  • 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.
  • 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".
  • Occurrence of Re-operations [ Time Frame: 5 year ]
    Occurrence of subjects that require any re-operation on the index knee from initial SCP Procedure.
  • Time to Re-operations [ Time Frame: 5 year ]
    Time from initial SCP Procedure to any re-operation
  • Occurrence of Revisions [ Time Frame: 5 year ]
    Occurrence of subjects that require revision on the index knee from initial SCP Procedure.
  • Time to Revisions [ Time Frame: 5 year ]
    Time from initial SCP Procedure to revisions
  • X-ray [ Time Frame: 12 months ]
    X-ray evaluation of alignment, joint space narrowing, osteophyte and cyst formation and subchondral sclerosis
  • MRI BML lesion size [ Time Frame: 12 months ]
    MRI evaluation of Bone Marrow Lesion Size
  • MRI BML type [ Time Frame: 12 months ]
    MRI evaluation of Bone Marrow Lesion Type
  • MRI Intraosseous vascularity [ Time Frame: 12 months ]
    MRI evaluation of Intraosseous Vascularity
  • MRI location of injectate [ Time Frame: 12 months ]
    MRI evaluation of Location of Injectate.
  • Adverse Events [ Time Frame: 5 year ]
    Occurrence of Adverse Events
Original Secondary Outcome Measures
 (submitted: February 5, 2018)
  • 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.
  • 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
  • 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
  • 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.
  • 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".
  • Occurrence of Re-operations [ Time Frame: 5 year ]
    Occurrence of subjects that require any re-operation on the index knee from initial SCP Procedure.
  • Time to Re-operations [ Time Frame: 5 year ]
    Time from initial SCP Procedure to any re-operation
  • Occurrence of Revisions [ Time Frame: 5 year ]
    Occurrence of subjects that require revision on the index knee from initial SCP Procedure.
  • Time to Revisions [ Time Frame: 5 year ]
    Time from initial SCP Procedure to revisions
  • X-ray [ Time Frame: 12 months ]
    X-ray evaluation of alignment, joint space narrowing, osteophyte and cyst formation and subchondral sclerosis
  • MRI [ Time Frame: 12 months ]
    BML variables via MRI
  • Adverse Events [ Time Frame: 5 year ]
    Occurrence of Adverse Events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with symptomatic BML(s) of the knee(s) who qualify for a SCP Procedure.
Condition
  • Bone Marrow Lesions
  • Bone Marrow Edema
Intervention 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
Study Groups/Cohorts Subchondroplasty Procedure
The SCP Procedure targets and fills bone defects with AccuFill bone substitute material utilizing an arthroscopic / percutaneous approach
Intervention: Device: Subchondroplasty Procedure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 5, 2018)
250
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 1, 2024
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Linda Korthout +31610072.853 linda.korthout@zimmerbiomet.com
Contact: Cahit Akbas +31622981737 cahit.akbas@zimmerbiomet.com
Listed Location Countries Germany,   Italy,   Netherlands,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03430219
Other Study ID Numbers SCP-EMEA-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Zimmer Biomet
Study Sponsor Zimmer Biomet
Collaborators Not Provided
Investigators
Principal Investigator: Peter Angele, Prof.Dr.med University of Regensburg
PRS Account Zimmer Biomet
Verification Date January 2019