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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)

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

Tracking Information
First Submitted Date  ICMJE March 12, 2019
First Posted Date  ICMJE March 15, 2019
Last Update Posted Date March 27, 2019
Actual Study Start Date  ICMJE May 9, 2018
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
change from baselino to follow up of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: 2,6,12 months ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Effectiveness of Combined Intra-articular and Intra-osseus Injection VS a Single Intra-articular Injection of Bone Marrow Concentrate
Official Title  ICMJE 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
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).

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE Biological: Bone Marrow Concentrate
Bone Marrow Concentrate injection
Study Arms  ICMJE
  • Active Comparator: Single intra-articular Bone Marrow Concentrate injection
    Single intra-articular Bone Marrow Concentrate injection in the knee
    Intervention: Biological: Bone Marrow Concentrate
  • Experimental: combined Bone Marrow Concentrate injection
    combined Bone Marrow Concentrate injection (intra-articular and intra-osseus)
    Intervention: Biological: Bone Marrow Concentrate
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  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 14, 2019)
86
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2021
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alessandro Di Martino, MD 0516366514 a.dimartino@biomec.ior.it
Contact: Alice Roffi, Phd 0516336072 alice.roffi@ior.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03876795
Other Study ID Numbers  ICMJE INTERFACE
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  ICMJE
Plan to Share IPD: No
Responsible Party Federica Balboni, Istituto Ortopedico Rizzoli
Study Sponsor  ICMJE Istituto Ortopedico Rizzoli
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Istituto Ortopedico Rizzoli
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP