- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03876795
Evaluation of Effectiveness of Combined Intra-articular and Intra-osseus Injection VS a Single Intra-articular Injection of Bone Marrow Concentrate (INTERFACE)
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
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).
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Bologna, Italy, 40136
- Rizzoli Orthopaedic Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or female patients, aged between 40 and 70;
- Arthrosis of the medial compartment (grade 2-3 according to the Kellgren-Lawrence score> 4 months);
- Failure after at least 6 months of conservative treatment (drug therapy with NSAIDs and painkillers, hyaluronic acid infiltration, corticosteroid infiltration, PRP);
- Patients' ability and consent to participate in clinical and radiological follow-up;
- Signature of informed consent.
Exclusion Criteria:
- Patients with trauma in the 6 months prior to surgery;
- Patients with maligncy;
- Patients suffering from rheumatic diseases;
- Patients suffering from non-compensated diabetes;
- Patients suffering from uncompensated thyroid metabolic disorders;
- Patients abusing alcoholic beverages, drugs or drugs;
- Patients with axial deviations> 5 °;
- Body Mass Index> 35;
- Patients treated with joint infiltrations in the previous 6 months;
- Patients treated with surgery at the same knee in the previous 12 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Single intra-articular Bone Marrow Concentrate injection
Single intra-articular Bone Marrow Concentrate injection in the knee
|
Bone Marrow Concentrate injection
|
Experimental: combined Bone Marrow Concentrate injection
combined Bone Marrow Concentrate injection (intra-articular and intra-osseus)
|
Bone Marrow Concentrate injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
basal 2,6,12 months after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2,6,12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- InterFACE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteoarthritis, Knee
-
LifeBridge HealthMicroPort Orthopedics Inc.; Rubin Institute for Advanced OrthopedicsRecruitingKnee Osteoarthritis | Osteoarthritis, Knee | Knee Pain Chronic | Arthropathy of Knee Joint | Knee Disease | Osteoarthritis Knees Both | Osteoarthritis Knee Left | Osteoarthritis Knee RightUnited States
-
University Hospital, Clermont-FerrandSanofiCompletedKnee Osteoarthritis (Knee OA)France
-
Joseph E. BroylesCompletedDegenerative Lesion of Articular Cartilage of Knee | Degeneration; Articular Cartilage, Knee | Unilateral Primary Osteoarthritis of Knee | Osteoarthritis Knee
-
The Hong Kong Polytechnic UniversityCompleted
-
Federal University of São PauloCompletedKNEE OSTEOARTHRITISBrazil
-
Jiangsu XinChen-Techfields Pharma Co., LTD.Completed
-
Thammasat UniversityCompletedPrimary Knee OsteoarthritisThailand
-
Galderma R&DCompletedUnilateral Knee OsteoarthritisUnited Kingdom
-
National Yang Ming UniversityFar Eastern Memorial HospitalCompletedMedial Knee OsteoarthritisTaiwan
-
Hanlim Pharm. Co., Ltd.CompletedKnee OsteoarthritisKorea, Republic of
Clinical Trials on Bone Marrow Concentrate
-
APM Spine and Sports PhysiciansUnknownDiscogenic PainUnited States
-
Rush University Medical CenterRecruitingOsteoarthritis of the KneeUnited States
-
Cardiogenesis Corporation, a wholly-owned subsidiary...TerminatedAnginaSpain, Russian Federation
-
Hospital ZnojmoCompleted
-
Yasser Mohamed Nabil Ahmed Khirat El HadidiCompletedHemifacial Microsomia | Distraction of Bone
-
Grigory KarmyRecruiting
-
Stem CuresUnknownLow Back Pain | Radiculopathy | Spinal Stenosis | Disc Degeneration | Disc Disease | Arthropathy Vertebrae | Sacral DisorderUnited States
-
Regenexx, LLCTerminatedOsteoarthritis, KneeUnited States
-
Regenerative Pain Center, IllinoisCompletedHip and Knee OsteoarthritisUnited States
-
Zimmer BiometNo longer availablePeripheral Arterial Disease | Peripheral Vascular Diseases | Critical Limb IschemiaUnited States