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Evaluation of Effectiveness of Combined Intra-articular and Intra-osseus Injection VS a Single Intra-articular Injection of Bone Marrow Concentrate (INTERFACE)

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. Identifier: NCT03876795
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : March 27, 2019
Information provided by (Responsible Party):
Federica Balboni, Istituto Ortopedico Rizzoli

Brief Summary:

Osteoarthritis (OA) is one of the most common diseases resulting in large burdens on society.

Among the emerging treatments, Bone Marrow Concentrate (BMC) intra-articular injections are a promising regenerative approach. However, they offer only a temporary benefit since they target synovial and chondral tissues but fail to address the osteochondral interface, which plays a key role in the onset and progression of joint degeneration.

This project will investigate the efficacy of combined BMC injections, targeting both intra-articular tissues and subchondral bone, to treat OA in a Randomized Controlled Trial (RCT).

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Biological: Bone Marrow Concentrate Phase 3

Detailed Description:

The main aim is to evaluate in a RCT the potential of a new combined BMC treatment for OA, through the use of scores for the clinical outcome, the study of imaging and biological samples for tissue regeneration and systemic effects, and the identification of BMC and patient characteristics predictive of better results.

All patients will undergo an arthroscopic procedure to debride degenerated tissues (this can offer a temporary benefit but not long lasting results) before BMC intra-articular injection. Half patients will receive also the injection of BMC at the subchondral level (bone samples obtained to allow BMC placement will be sent to the Lab).

The same minimally invasive incisions will be used for all patients, ensuring patient blinding. Evaluations, performed by medical staff not involved in the treatment to ensure double blinding, will document subjective clinical improvement, functional measurements, biomarker study, and imaging with the use of modern 3TMRI and qCT technology. BMC characterization and patient features will be analysed to identify factors predictive of a better outcome.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Effectiveness of Combined Intra-articular and Intra-osseus Injection VS a Single Intra-articular Injection of Bone Marrow Concentrate for the Treatment of Osteoarthritis in the Knee. (INTERFACE) Double Blind, Randomized Clinical Trial
Actual Study Start Date : May 9, 2018
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Active Comparator: Single intra-articular Bone Marrow Concentrate injection
Single intra-articular Bone Marrow Concentrate injection in the knee
Biological: Bone Marrow Concentrate
Bone Marrow Concentrate injection

Experimental: combined Bone Marrow Concentrate injection
combined Bone Marrow Concentrate injection (intra-articular and intra-osseus)
Biological: Bone Marrow Concentrate
Bone Marrow Concentrate injection

Primary Outcome Measures :
  1. change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score trend over time [ Time Frame: basal 2,6,12 months after treatment ]
    WOMAC is a validated score, designed to highlight the problems of patients with lower limb pathologies, in particular in terms of pain, stiffness and functionality. The score will be completed by the patient, possibly in the presence of an investigator, and simple guidelines for self-compilation will be provided.

Secondary Outcome Measures :
  1. IKDC Subjective Knee Evaluation Form (IKDC) [ Time Frame: 2,6,12 months ]
    IKDC is a validated score used in the evaluation of symptoms, function and sport activity in patients suffering of knee diseases, such as meniscal or ligamentous damage, osteoarthritis. The Subjective Knee Form provides the best method of overall assessment of the most significant symptoms and disabilities for a population that has undergone cartilage repair treatments.

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:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female patients, aged between 40 and 70;
  2. Arthrosis of the medial compartment (grade 2-3 according to the Kellgren-Lawrence score> 4 months);
  3. Failure after at least 6 months of conservative treatment (drug therapy with NSAIDs and painkillers, hyaluronic acid infiltration, corticosteroid infiltration, PRP);
  4. Patients' ability and consent to participate in clinical and radiological follow-up;
  5. Signature of informed consent.

Exclusion Criteria:

  1. Patients with trauma in the 6 months prior to surgery;
  2. Patients with maligncy;
  3. Patients suffering from rheumatic diseases;
  4. Patients suffering from non-compensated diabetes;
  5. Patients suffering from uncompensated thyroid metabolic disorders;
  6. Patients abusing alcoholic beverages, drugs or drugs;
  7. Patients with axial deviations> 5 °;
  8. Body Mass Index> 35;
  9. Patients treated with joint infiltrations in the previous 6 months;
  10. Patients treated with surgery at the same knee in the previous 12 months.

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 identifier (NCT number): NCT03876795

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Contact: Alessandro Di Martino, MD 0516366514
Contact: Alice Roffi, Phd 0516336072

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Rizzoli Orthopaedic Institute Recruiting
Bologna, Italy, 40136
Contact: Alessandro Di Martino, MD    0516366514   
Contact: Alice Roffi, PhD    0516366072      
Sponsors and Collaborators
Istituto Ortopedico Rizzoli

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Responsible Party: Federica Balboni, Sub-Investigator, Istituto Ortopedico Rizzoli Identifier: NCT03876795    
Other Study ID Numbers: INTERFACE
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Federica Balboni, Istituto Ortopedico Rizzoli:
Bone Marrow Comcentrate
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases